the
Is she getting right support for her menopause symptoms?
Explore the most common clinical questions around menopause and vasomotor symptoms – and gain applicable knowledge you can use in practice today.
MAT-NO-VEO-2025-00048 | Date of preparation 21.10.2025
to
Explore approaches support women with vasomotor symptoms (VMS)
What’s happening to my patients?
Is VEOZA right for her?
What can patients expect from VEOZA?
What to consider when prescribing VEOZA?
Learn about menopause and VMS, why symptoms occur, and their impact on women and society.
Understand the challenges women face when VMS go untreated.
Discover how VEOZA works and which patients are suitable for this therapy. Explore different patient profiles and understand who may benefit from this treatment.
Explore the clinical data supporting VEOZA’s efficacy and safety profile in treating VMS. Learn how this therapy provides clinically meaningful relief for patients.
Learn about the prescribing considerations for VEOZA therapy. Access dosing protocols, contraindications, and safety considerations before starting therapy.
What’s happening to my patients?
Is VEOZA right for her?
What can patients expect from VEOZA?
What to consider when prescribing VEOZA?
How much do you know about menopause & VMS?
QUIZ
Back
What to expect when menopause symptoms appear?
MENOPAUSE
What is the extent of the VMS burden for women and society?
LIFE WITH VMS
What's happening my patients?
to
What's happening in the body when VMS occur?
MECHANISM OF VMS
Menopause is associated with a wide range of symptoms – some clearly linked to hormonal changes, others less immediately recognised. VMS, also known as hot flushes and night sweats, are common and often underreported.1,2 Learn how these symptoms
can impact your patients.
What are the current VMS treatments and barriers to care?
TREATMENT OPTIONS
MAT-NO-VEO-2025-00048 | Date of preparation 21.10.2025
Abbreviations & references
How much do you know about menopause & VMS?
QUIZ
Back
What to expect when menopause symptoms appear?
MENOPAUSE
What's happening my patients?
to
What is the extent of the VMS burden for women and society?
LIFE WITH VMS
Menopause is associated with a wide range of symptoms – some clearly linked to hormonal changes, others less immediately recognised. VMS, also known as hot flushes and night sweats, are common and often underreported.1,2 Learn how these symptoms
can impact your patients.
What's happening in the body when VMS occur?
MECHANISM OF VMS
more
Do you want information?
Get the latest updates and events related to VMS and VEOZA
What are the current VMS treatments and barriers to care?
TREATMENT OPTIONS
MAT-NO-VEO-2025-00048 | Date of preparation 21.10.2025
Abbreviations & references
MENOPAUSE
Back
when
What TO expect menopause symptoms appear?
Menopause is a natural biological process marking the permanent cessation of menstruation for at least 12 consecutive months, resulting from the loss of ovarian follicular activity.1,2
Menopause transition:
menopause
Premenopause
postmenopause
perimenopause
51 yr on average Final menstrual period
35-45 yr Last regular menstrual cycle
11-15 yr Menarche
12 months with amenorrhoea
Figure adapted from references 3 and 4.
References
MENOPAUSE
Back
What TO expect menopause symptoms appear?
when
The symptoms of menopause can be very distressing and can considerably affect the personal, social, and work lives of women.1
Click to
EXPLORE
Vasomotor symptoms
Vasomotor symptoms (VMS):
Central nervous system
Skin, mucosa, & hair
Occurring often multiple times a day, VMS are reported as the most burdensome symptoms of menopause.1,2
VMS affect up to
80%
of women1,3
Muscoskeletal system
Substantially impact women’s QoL by severely affecting:1,2
Weight & metabolism
Energy levels
Concentration
Sleep
Mood
Sexual function
Despite VMS being one of the main reasons for seeking menopause treatment,3,4 VMS remain
undertreated.3
Urogenital system
Figure adapted from reference 1.
Abbreviations & references
MENOPAUSE
Back
What TO expect menopause symptoms appear?
when
Different trajectories of VMS scores (based on self-reported frequency of hot flushes and night sweat):2
Severity types of VMS:1
Flip the cards to learn more about VMS severity.
MILD
MODERATE
SEVERE
A sensation of heat with sweating. Ability to continue with activities.
A sensation of heat with sweating. Causes cessation of activities.
A sensation of heat without sweating.
SEVERE
MODERATE
MILD
Figure adapted from reference 2.
Duration of symptoms:
median of 7.4 years3
Women follow different VMS patterns, underlining the individual nature of menopause2
Abbreviations & references
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
VMS last for a median of 7.4 years and generally peak within the first two years after the final menstrual period.1,2
EFFECT ON WOMEN'S QoL
Night sweats frequency
Prevalence
Hot flushes frequency
80%
VMS can have a negative impact on women’s QoL.
The frequency of
night sweats varies greatly, from only a few times a month to several times a night.3
The frequency of
hot flushes varies greatly, from only a few times a month to several times a day.3
Up to
VMS are frequently associated with:4-5
Do you know how many hot flushes women experience daily?
Do you know how many night sweats women experience daily?
Do you know how many women experience VMS during the menopausal transition?
Do you know how VMS can affect women’s quality of life?
Sleep disruption
Peri- and postmenopausal women can experience multiple VMS episodes per night – with most reporting 1–2 nightly episodes.3
Peri- and postmenopausal women can experience multiple VMS episodes per day – with some reporting 7 or more hot flushes daily.3
Reduced focus
will experience VMS during the menopausal transition.1-4
Impaired productivity
Abbreviations & references
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
VMS trigger a “domino effect” of symptoms
Beyond the primary heat sensation and sweating, VMS can trigger a cascade of secondary symptoms such as sleep disturbances, cognitive difficulties, and mood changes, that intensify with VMS frequency.1-3
Click on the icons to
EXPLORE
VMS
Figure made by Astellas from references 3–14.
Abbreviations & references
1.7
million
menopausal women
In the Nordic region, nearly
1.7 million women are aged 45–54 years, the typical range for menopause onset.6
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
How VMS can impact women in the 21st century:
1/3
Increased life expectancy means that many women will spend up to a third of their lives postmenopausal.1
This life phase may be even longer for
women experiencing early menopause.1
Increased life expectancy
Impact on work and private life
Treatment gaps
Abbreviations & references
1.7
million
menopausal women
In the Nordic region, nearly
1.7 million women are aged 45–54 years, the typical range for menopause onset.6
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
How VMS can impact women in the 21st century:
Increased life expectancy
Multiple studies demonstrate that VMS significantly impair QoL and productivity at:2,3
Home
Impact on work and private life
Work
Treatment gaps
Abbreviations & references
1.7
million
menopausal women
In the Nordic region, nearly
1.7 million women are aged 45–54 years, the typical range for menopause onset.6
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
How VMS can impact women in the 21st century:
Increased life expectancy
VMS are the primary reason why women seek menopause care.2
However, VMS remain widely untreated.4
Impact on work and private life
of symptomatic women do not take treatment for their VMS5
>60%
not receiving therapy even after clinical consultation2
40%
Treatment gaps
Abbreviations & references
1.7
million
menopausal women
In the Nordic region, nearly
1.7 million women are aged 45–54 years, the typical range for menopause onset.6
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
How VMS can impact women in the 21st century:
1/3
Increased life expectancy means that many women will spend up to a third of their lives postmenopausal.1
This life phase may be even longer for
women experiencing early menopause.1
Increased life expectancy
Impact on work and private life
Treatment gaps
Abbreviations & references
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
VMS in working women in the Nordics
Presenteeism and absenteeism
Nordic women represent nearly half the workforce and are among the most economically active worldwide.1,2
Moderate to severe VMS significantly reduce work productivity through both presenteeism and absenteeism, especially during women’s most professionally active years.6
Reduced productivity while at work.6
Presenteeism:
Absence from work.6
Absenteeism:
Women comprise the majority in healthcare, public services, and service sectors.3–5
Across the Nordic countries,
the estimated annual costs due to VMS are
~€865 million.6
How do VMS affect women in my country?
Click to expand the graph
Understanding menopause's impact on workforce participation is crucial, with growing economic implications as more women work through and beyond menopause.1,6
Abbreviations & references
MECHANISM OF VMS
Back
when
What's happening in the body VMS occur?
During menopause, dropping oestrogen levels disrupt the brain's temperature control. This leads to an overactivity of the thermoregulatory centre, causing hot flushes and night sweats.1,2
Narrowing of the interthreshold zone throughout menopause3
With menopause, the natural depletion of ovarian follicles leads to a drop in circulating oestrogen.1,2 At this point, the regulatory control of KNDy neurons is lost.3
PERIMENOPAUSE
Oestrogen secreted by the ovaries regulates KNDy neurons in the hypothalamus,1 which help maintain the core temperature of the body within the sweating and shivering thresholds.3
PREMENOPAUSE
At low oestrogen levels, the thermoneutral zone is narrowed. This causes exaggerated physiological responses that are experienced as hot flushes and night sweats.3
MENOPAUSE
PERIMENOPAUSE
PREMENOPAUSE
MENOPAUSE
Sweating threshold
Hot flushes
Core body temperature
Body temperature fluctuation
Shiveringthreshold
Figure adapted from reference 3.
Abbreviations & references
MECHANISM OF VMS
Back
when
What's happening in the body VMS occur?
Inside a hot flush: from brain to symptom
KNDy neurons, located in the hypothalamus, are typically balanced by oestrogen and NKB and become hyperactive as oestrogen declines during menopause. This imbalance leads to increased NKB signalling, dysregulating the thermoregulatory centre and consequently leading to VMS.1,2
peri- and postmenopause3
Premenopause3
Switch between premenopause and peri- and postmenopause and click to explore
NK3R
NK3R
NKB binds to neurokinin 3 receptors (NK3R).
Normal cooling
KNDY neuron
Physiological response
Regulated NKB signalling results in normal cooling of the body.
KNDy neuron
KNDy neurons innervate the thermoregulatory centre and are stimulated by NKB via NK3R and are inhibited by oestrogen.
Thermoregulatory centre
Changes in temperature trigger heat dissipation mechanisms, like sweating and peripheral vasodilatation.
NKB
NKB
NKB stimulates KNDy neurons.
Thermo- regulatory centre
NKB signalling
Balanced KNDy activity, maintained by oestrogen’s inhibition of KNDy neurons, keeps
the thermoregulatory centre stable.
Oestrogen
Oestrogen
Circulating oestrogen inhibits KNDy neurons.
NKB signalling
Figure adapted from reference 3.
Abbreviations & references
MECHANISM OF VMS
Back
when
What's happening in the body VMS occur?
Inside a hot flush: from brain to symptom
KNDy neurons, located in the hypothalamus, are typically balanced by oestrogen and NKB and become hyperactive as oestrogen declines during menopause. This imbalance leads to increased NKB signalling, dysregulating the thermoregulatory centre and consequently leading to VMS.1,2
Premenopause3
peri- and postmenopause3
NK3R
NK3R
Increased NKB binds to neurokinin 3 receptors (NK3R).
KNDy neuron
KNDy neurons become hypertrophied, contributing to increased signalling to the thermoregulatory centre.
Hot flushes
Hot flushes
Increased activation of heat dissipation mechanisms results in hot flushes and night sweats.
KNDY neuron
Altered thermoregulatory centre
Altered signalling in the thermoregulatory centre shifts the balance for control of core body temperature and activates heat dissipation effectors.
NKB
NKB
NKB stimulates KNDy neurons further, as oestrogen declines.
Increased NKB signalling
Loss of oestrogen inhibition causes KNDy overactivity, increasing NKB signals to the thermoregulatory centre.
Thermo- regulatory centre
Oestrogen
Oestrogen
Declining oestrogen levels leave NKB signalling unopposed.
NKB signalling
Figure adapted from reference 3.
Abbreviations & references
MECHANISM OF VMS
Back
when
What's happening in the body VMS occur?
Inside a hot flush: from brain to symptom
KNDy neurons, located in the hypothalamus, are typically balanced by oestrogen and NKB and become hyperactive as oestrogen declines during menopause. This imbalance leads to increased NKB signalling, dysregulating the thermoregulatory centre and consequently leading to VMS.1,2
peri- and postmenopause3
Premenopause3
NK3R
NK3R
NKB binds to neurokinin 3 receptors (NK3R).
KNDy neuron
KNDy neurons innervate the thermoregulatory centre and are stimulated by NKB via NK3R and are inhibited by oestrogen.
Normal cooling
KNDY neuron
Physiological response
Regulated NKB signalling results in normal cooling of the body.
Thermoregulatory centre
Changes in temperature trigger heat dissipation mechanisms, like sweating and peripheral vasodilatation.
NKB
NKB
NKB stimulates KNDy neurons.
NKB signalling
Balanced KNDy activity, maintained by oestrogen’s inhibition of KNDy neurons, keeps
the thermoregulatory centre stable.
Thermo- regulatory centre
Oestrogen
Oestrogen
Circulating oestrogen inhibits KNDy neurons.
NKB signalling
Figure adapted from reference 3.
Abbreviations & references
MECHANISM OF VMS
Back
when
What's happening in the body VMS occur?
During menopause, dropping oestrogen levels disrupt the brain's temperature control. This leads to an overactivity of the thermoregulatory centre, causing hot flushes and night sweats.1,2
Narrowing of the interthreshold zone throughout menopause3
At low oestrogen levels, the thermoneutral zone is narrowed. This causes exaggerated physiological responses that are experienced as hot flushes and night sweats.3
MENOPAUSE
Oestrogen secreted by the ovaries regulates KNDy neurons in the hypothalamus,1 which help maintain the core temperature of the body within the sweating and shivering thresholds.3
PREMENOPAUSE
With menopause, the natural depletion of ovarian follicles leads to a drop in circulating oestrogen.1,2 At this point, the regulatory control of KNDy neurons is lost.3
PERIMENOPAUSE
Sweating threshold
Hot flushes
Core body temperature
Body temperature fluctuation
Shiveringthreshold
Figure adapted from reference 3.
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Despite available treatments, many women with moderate to severe VMS remain untreated, highlighting an unmet need.1-3
Can you identify the hidden barriers for menopause care? Click on the dialogues to explore.
BARRIERS
TREATMENT GAPS
Lack of information about available prescription treatment options may deter women from seeking treatment until symptoms become severe, and insufficient knowledge among HCPs about the full range of menopause therapies can further limit access to appropriate care.3,5
Menopause is often viewed as a natural and inevitable part of aging, and because it affects all women, many believe it doesn’t require any treatment.2-4
"You’ll be fine, menopause is natural"
"I don’t know the treatment options"
Many patients feel discomfort discussing intimate symptoms and may experience stigma around menopause and limited awareness of treatment options.3-5
Classic menopause symptoms can be easily diagnosed. However, subtle or isolated symptoms are often dismissed or misattributed to other conditions, with menopause frequently overlooked.3
"I don’t get the help I need from my doctor"
"I don’t like talking about it"
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Despite available treatments, many women with moderate to severe VMS remain untreated, highlighting an unmet need.1-3
Treatment gaps often go unnoticed until they widen. Explore the underlying gaps in VMS care.
TREATMENT GAPS
BARRIERS
43–50%
5,*
How many postmenopausal women experiencing VMS do not seek medical help?
Less than
50%
6,†
What percentage of GPs feel comfortable managing and treating patients with menopause-related health problems?
46%
4,‡
Among Nordic women, how many have never received any treatment for VMS, regardless of seeking advice?
*Based on an online survey conducted across five European countries (France, Germany, Italy, Spain, and the United Kingdom; N=2610).5 †Based on an online survey and interview conducted with GPs in the United Kingdom (N=173).6 ‡Based on an online survey conducted with women aged 40–65 years in the Nordics (Denmark, Finland, Norway, and Sweden; N=863).4
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Despite available treatments, many women with moderate to severe VMS remain untreated, highlighting an unmet need.1-3
Can you identify the hidden barriers for menopause care? Click on the dialogues to explore.
BARRIERS
TREATMENT GAPS
Lack of information about available prescription treatment options may deter women from seeking treatment until symptoms become severe, and insufficient knowledge among HCPs about the full range of menopause therapies can further limit access to appropriate care.3,5
Menopause is often viewed as a natural and inevitable part of aging, and because it affects all women, many believe it doesn’t require any treatment.2-4
"You’ll be fine, menopause is natural"
"I don’t know the treatment options"
Many patients feel discomfort discussing intimate symptoms and may experience stigma around menopause and limited awareness of treatment options.3-5
Classic menopause symptoms can be easily diagnosed. However, subtle or isolated symptoms are often dismissed or misattributed to other conditions, with menopause frequently overlooked.3
"I don’t get the help I need from my doctor"
"I don’t like talking about it"
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Treatment options for VMS have evolved significantly, offering women multiple therapeutic approaches that differ in their mechanisms of action, effectiveness, safety, and patient suitability.1-3
MENOPAUSAL HORMONE THERAPY (MHT)
NON-hormonal therapies
Self-help strategies
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Treatment options for VMS have evolved significantly, offering women multiple therapeutic approaches that differ in their mechanisms of action, effectiveness, safety, and patient suitability.1-3
MENOPAUSAL HORMONE THERAPY (MHT)
- Current treatment classes for hot flushes and night sweats include hormone therapy, which has long been the standard of care.4
NON-hormonal therapies
Self-help strategies
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Treatment options for VMS have evolved significantly, offering women multiple therapeutic approaches that differ in their mechanisms of action, effectiveness, safety, and patient suitability.1-3
NON-hormonal therapies
- Non-hormonal therapies provide an alternative for women unable or unwilling to take MHT.1,3
- There are both on- and off-label non-hormonal options available to treat VMS.4,5
MENOPAUSAL HORMONE THERAPY (MHT)
Self-help strategies
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Treatment options for VMS have evolved significantly, offering women multiple therapeutic approaches that differ in their mechanisms of action, effectiveness, safety, and patient suitability.1-3
self-help strategies
- Other treatment strategies include over-the-counter remedies like supplements and herbs.4
MENOPAUSAL HORMONE THERAPY (MHT)
NON-hormonal therapies
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Treatment options for VMS have evolved significantly, offering women multiple therapeutic approaches that differ in their mechanisms of action, effectiveness, safety, and patient suitability.1-3
MENOPAUSAL HORMONE THERAPY (MHT)
NON-hormonal therapies
Self-help strategies
Abbreviations & references
Back
and
QUICK CHECK: MENOPAUSE VMS
VMS affects millions of women, yet many cases go untreated. As VMS is the most common and often reported as the most bothersome symptom during the menopausal transition, understanding its mechanisms, duration, and the latest evidence is key to better supporting patients.1-3 Test your knowledge with this quick quiz.
Abbreviations & references
QUIZ
Back
Quick check: Menopause & VMS
of
QUESTION 1 5
Do you know the median duration of VMS?
2.7 years
4.8 years
5.6 years
7.4 years
Abbreviations & references
QUIZ
Back
Quick check: Menopause & VMS
of
QUESTION 2 5
How common are VMS among women in the menopausal transition?
Up to 2 in 10 women experience VMS
Up to 5 in 10 women experience VMS
Up to 8 in 10 women experience VMS
Every woman experiences VMS
Abbreviations & references
QUIZ
Back
Quick check: Menopause & VMS
of
QUESTION 3 5
Do you know the role of KNDy neurons in VMS pathophysiology?
They respond to temperature changes by regulating norepinephrine release
They become hyperactive due to loss of oestrogen inhibition, disrupting thermoregulation
They regulate vasodilation through spinal cord reflexes
They stimulate sweat glands directly through autonomic pathways
Abbreviations & references
QUIZ
Back
Quick check: Menopause & VMS
of
QUESTION 4 5
Why is blocking neurokinin B (NKB)-mediated activation of KNDy neurons effective in the treatment of VMS?
Because it restores normal KNDy neuron activity, reducing overstimulation of thermoregulatory pathways
Because it stimulates oestrogen production through the hypothalamic-pituitary feedback loop
Because it enhances serotonin activity, stabilising temperature regulation
Because it promotes cooling by directly stimulating peripheral vasodilation
Abbreviations & references
QUIZ
Back
Quick check: Menopause & VMS
of
QUESTION 5 5
What proportion of women with menopausal symptoms seek treatment?
Almost every woman
Around 3/4 of women
Around half of women
Around 1/4 of women
Abbreviations & references
Back
Is VEOZA right her?
for
Many women experience persistent moderate to severe VMS despite of lifestyle modifications or current therapies. VEOZA might provide a non-hormonal alternative for patients with unmet needs, hormone therapy contraindications or with non-hormonal therapy preferences.1,2 VEOZA™ (fezolinetant) is indicated for the treatment of moderate to severe VMS associated with menopause.3,*
How does VEOZA support VMS treatment?
MODE OF ACTION
How do I identify patients who might benefit from VEOZA?
PATIENT PROFILES
*See section 5.1 in SmPC.
MAT-NO-VEO-2025-00051 | Date of preparation 21.10.2025
Abbreviations & references
Back
Is VEOZA right her?
for
Many women experience persistent moderate to severe VMS despite of lifestyle modifications or current therapies. VEOZA might provide a non-hormonal alternative for patients with unmet needs, hormone therapy contraindications or with non-hormonal therapy preferences.1,2 VEOZA™ (fezolinetant) is indicated for the treatment of moderate to severe VMS associated with menopause.3,*
more
Do you want information?
Get the latest updates and events related to VMS and VEOZA
How does VEOZA support VMS treatment?
MODE OF ACTION
How do I identify patients who might benefit from VEOZA?
PATIENT PROFILES
*See section 5.1 in SmPC.
MAT-NO-VEO-2025-00051 | Date of preparation 21.10.2025
Abbreviations & references
MODE OF ACTION
Back
How does VEOZA support VMS treatment?
VEOZA is indicated for the treatment of moderate to severe VMS associated with menopause.1,*
NON-HORMONAL
NK3R ANTAGONIST
Addresses the source of VMS
*See section 5.1 in SmPC.
Abbreviations & references
MODE OF ACTION
Back
How does VEOZA support VMS treatment?
VEOZA is indicated for the treatment of moderate to severe VMS associated with menopause.1,*
NON-HORMONAL
Non-Hormonal Therapy
As a non-hormonal therapy, VEOZA offers an alternative for women who cannot or prefer not to use menopausal hormone therapy. This might provide an alternative to address an unmet need.2,3
NK3R ANTAGONIST
Addresses the source of VMS
*See section 5.1 in SmPC.
Abbreviations & references
MODE OF ACTION
Back
How does VEOZA support VMS treatment?
VEOZA is indicated for the treatment of moderate to severe VMS associated with menopause.1,*
NON-HORMONAL
NK3R ANTAGONIST
NK3R ANTAGONIST
VEOZA is a first-in-class NK3R antagonist that targets KNDy neurons in the hypothalamus, which are a source of VMS.2,3
Addresses the source of VMS
*See section 5.1 in SmPC.
Abbreviations & references
MODE OF ACTION
Back
How does VEOZA support VMS treatment?
VEOZA is indicated for the treatment of moderate to severe VMS associated with menopause.1,*
NON-HORMONAL
NK3R ANTAGONIST
Addresses the source of VMS
By blocking the binding of NKB to the NK3 receptor, VEOZA helps reduce heat signals at their source, offering relief from hot flushes and night sweats.2-4
Addresses the source of VMS
*See section 5.1 in SmPC.
Abbreviations & references
MODE OF ACTION
Back
How does VEOZA support VMS treatment?
Watch VEOZA’s mode of action:
Abbreviations
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Sara*
Maria*
Katarina*
Michelle*
Eligible for MHT, but cautious due to risk profile
Cautious / contraindicated for MHT
Untreated, prefers
non-hormonal treatment options
Wants to discuss other non-hormonal options
Sara seeks relief for her VMS and prefers a non-hormonal option due to her underlying health conditions.
Maria is currently untreated due to her medical history, but she is looking for a VMS treatment that suits her needs.
Katarina would like help with her VMS, but does not want hormones.
Michelle has issues with her current treatment, and she wants to explore other non-hormonal treatment options.
Explore
Explore
Explore
Explore
*Hypothetical patient profile.
Abbreviations
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Katarina*
Untreated, prefers
non-hormonal treatment options
Katarina would like help with her VMS, but does not want hormones.
About Katarina
- Katarina is a 49-year-old woman
- She lives alone with her teenage daughter
- She works as a high school teacher
- She has a very active social life in her spare time
- Currently, she is seeking treatment for her VMS
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Katarina*
Untreated, prefers
non-hormonal treatment options
Katarina would like help with her VMS, but does not want hormones.
Symptoms
VMS began about 6 months ago and have gradually worsened over time.
Hot flushes:
Sudden waves of heat affect her concentration and comfort at work and make her feel uncomfortable during classes.
Night Sweats:
Frequent episodes disrupt her sleep, leaving her soaked and needing to change clothes.
Poor sleep quality due to night sweats impacts Katarina’s next-day energy, making her tired and irritable, affecting her mood and performance.
Sleep disruption:
Low energy:
Katarina feels constantly drained and lacks her usual vitality throughout the day.
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Katarina*
Untreated, prefers
non-hormonal treatment options
Katarina would like help with her VMS, but does not want hormones.
Treatment
- OTC: Katarina has tried various over-the-counter options, but she was not satisfied.
- No medication: She initially discussed her symptoms with her GP and was offered MHT, which she did not want. Believing her symptoms might improve with time, she tried to manage them herself, but after six months without improvement she sought help from her doctor again.
Looking for:
Non-hormonal
Lasting effect
Less disturbed sleep
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Katarina*
Untreated, prefers
non-hormonal treatment options
Katarina would like help with her VMS, but does not want hormones.
How can VEOZA help?
Non-hormonal
VEOZA is a first-in-class NK3R antagonist that targets specific neurons in the hypothalamus, which are a source of VMS.1,2
Lasting effect
Patients taking VEOZA experienced a reduction in the mean daily frequence of VMS episodes, which was sustained up to 52 weeks.3,4 See statistics under footnotes.‡
Less disturbed sleep
Women taking VEOZA reported less bothersome sleep disturbances at Week 12 compared to the placebo group.3-5 See statistics under footnotes.§
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
About Michelle
- Michelle is a 53-year-old woman
- She lives with her husband and their dog
- She works as a designer at a marketing agency
- She enjoys art and going to museums
- She is currently taking an SSRI† off-label for her VMS, but wants to try another non-hormonal option
Michelle*
Wants to discuss other non-hormonal options
Michelle has issues with her current treatment, and she wants to explore other non-hormonal treatment options.
†No SSRIs have an approved indication for the treatment of VMS in Europe (https://www.ema.europa.eu/en/medicines), but they are mentioned in guidelines as a treatment option (https://metodebok.no/index.php?action=topic&item=XfjH5Pzi. Accessed 17.09.2025).
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Symptoms
VMS began 2 years ago and have gradually intensified over time.
Meeting disruptions:
Sudden hot flushes interrupt Michelle’s professional interactions, making her feel embarrassed in front of colleagues and clients.
Sleep fragmentation:
She wakes up 3-4 times nightly, due to drenching night sweats, making her feel exhausted.
Michelle*
Wants to discuss other non-hormonal options
Mood volatility:
Unexpected symptom flare-ups trigger intense irritability and anxiety, that she struggles to manage.
Physical discomfort:
Intense sweating episodes force her to change clothes during the workday, leaving her feeling self-conscious and constantly worried about her appearance.
Michelle has issues with her current treatment, and she wants to explore other non-hormonal treatment options.
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Treatment
- SSRI therapy: Michelle started on SSRI† for VMS due to her preference to avoid hormone therapy.
- Current status: Despite some improvement, she went back to her doctor to discuss other non-hormonal treatment options.
Michelle*
†No SSRIs have an approved indication for the treatment of VMS in Europe (https://www.ema.europa.eu/en/medicines), but they are mentioned in guidelines as a treatment option (https://metodebok.no/index.php?action=topic&item=XfjH5Pzi. Accessed 17.09.2025).
Wants to discuss other non-hormonal options
Looking for:
Michelle has issues with her current treatment, and she wants to explore other non-hormonal treatment options.
Non-hormonal
Fewer episodes
Milder episodes
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
How can VEOZA help?
Non-hormonal
VEOZA is a first-in-class NK3R antagonist that targets KNDy neurons in the hypothalamus, which are a source of VMS.1,2
fewer episodes
Michelle*
VEOZA eliminated ~2 out of every 3 VMS episodes (63% reduction) at
Week 12.1 See statistics under footnotes.‡
Wants to discuss other non-hormonal options
milder episodes
VEOZA reduced VMS severity of remaining episodes – shifting from moderate/severe at baseline to mostly mild/moderate by Week 12.1,3,4 See statistics under footnotes.§
Michelle has issues with her current treatment, and she wants to explore other non-hormonal treatment options.
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Maria*
Cautious / contraindicated for MHT
Maria is currently untreated due to her medical history, but she is looking for a VMS treatment that suits her needs.
About Maria
- Maria is a 54-year-old woman
- She lives with her partner
- She holds a leadership role with a demanding schedule and frequent travel
- She enjoys spending quiet evenings at home
- She has a personal history of thromboembolism, which makes her cautious / contraindicated for MHT
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Maria*
Cautious / contraindicated for MHT
Maria is currently untreated due to her medical history, but she is looking for a VMS treatment that suits her needs.
Symptoms
VMS started 18 months ago and continue to worsen, creating additional challenges alongside her already demanding schedule.
Unpredictable episodes:
Hot flushes strike Maria during critical client meetings and high-stakes presentations, and she struggles to regain her composure.
Performance impact:
Disrupted sleep from night sweats leaves her mentally foggy, affecting her ability to perform at the quality level her role demands.
Concentration issues:
VMS make it harder for Maria to maintain her usual focus and decision-making abilities.
Stress cycle:
Her symptoms intensify during high-pressure situations, creating additional workplace anxiety.
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Maria*
Cautious / contraindicated for MHT
Maria is currently untreated due to her medical history, but she is looking for a VMS treatment that suits her needs.
Treatment
- MHT caution / contraindication: Maria’s history of thromboembolism requires caution / contraindicates MHT use.1 Despite implementing lifestyle adjustments, her symptoms continue to disrupt her demanding schedule.
- Seeking options: Open to exploring non-hormonal treatments that provide symptom relief.
Looking for:
Non-hormonal
Lasting effect
EARLY EFFECT
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Maria*
Cautious / contraindicated for MHT
Maria is currently untreated due to her medical history, but she is looking for a VMS treatment that suits her needs.
How can VEOZA help?
Non-hormonal
VEOZA is a first-in-class NK3R antagonist that targets KNDy neurons in the hypothalamus, which are a source of VMS.2,3
Lasting effect
Patients taking VEOZA experienced a reduction in the daily frequency of VMS episodes, which was sustained up to 52 weeks.4,5 See statistics under footnotes.‡
EARLY EFFECT
Patients taking VEOZA experienced a reduction in VMS episodes as early as Week 4.4,5 See statistics under footnotes.§
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Sara*
Eligible for MHT, but cautious due to risk profile
Sara seeks relief for her VMS and prefers a non-hormonal option due to her underlying health conditions.
About Sara
- Sara is a 50-year-old woman
- She lives with her husband and a teenage son
- She works at the city administrative office
- She has a high BMI and smokes occasionally, increasing her CV risk
- She enjoys long walks and catching up with friends over coffee
- She has previously tried systemic MHT under careful supervision given her risk profile
- She wants to explore other alternatives for her VMS
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Sara*
Eligible for MHT, but cautious due to risk profile
Sara seeks relief for her VMS and prefers a non-hormonal option due to her underlying health conditions.
Symptoms
VMS began 2 years ago and have become increasingly frequent and severe, so she contacted her doctor to get help.
Personal discomfort:
Sudden hot flushes drain Sara’s energy and make managing daily tasks challenging.
Sleep disturbances:
Night sweats wake Sara repeatedly, leaving her fatigued for her work and family activities.
Lifestyle limitations:
Symptoms interfere with her work and social coffee dates with friends.
Family impact:
Fatigue and irritability from poor sleep affect her interactions with her husband and teenage son.
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Sara*
Eligible for MHT, but cautious due to risk profile
Sara seeks relief for her VMS and prefers a non-hormonal option due to her underlying health conditions.
Treatment
- MHT: Sara tried systemic MHT, which initially relieved her symptoms, but she and her doctor decided to stop the treatment for medical reasons.
- Current status: Discontinued MHT and now seeks alternatives, given her higher BMI and occasional smoking.
Looking for:
Studied safety profile for VMS‡
Non-hormonal
Milder episodes
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Sara*
Eligible for MHT, but cautious due to risk profile
Sara seeks relief for her VMS and prefers a non-hormonal option due to her underlying health conditions.
How can VEOZA help?
Non-hormonal
VEOZA is a first-in-class NK3R antagonist that targets KNDy neurons in the hypothalamus, which are a source of VMS.1,2
milder episodes
VEOZA reduced VMS severity of remaining episodes – shifting from moderate/severe at baseline to mostly mild/moderate by Week 12.1,3,4 See statistics under footnotes.§
Studied safety profile for VMS‡
In the clinical trials, there were no SAEs at an incidence >1% across the total study population. The most common TEAEs (≥3%) were diarrhoea (3.2%) and insomnia (3.0%).5,¶
‡Liver function tests must be performed prior to treatment initiation and monthly during the first three months; thereafter based on clinical judgement. Treatment should not be started or continued if test results meet pre-defined criteria.5 – This section has been rewritten and/or abbreviated compared to the authorised SmPC.
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
How effective is VEOZA at reducing VMS frequency?
EFFICACY: FREQUENCY
Back
How effective is VEOZA at reducing VMS severity?
EFFICACY: SEVERITY
What should I know about VEOZA’s safety profile?
SAFETY PROFILE
Can treating VMS positively impact sleep quality?
SLEEP IMPROVEMENT
What patients expect from VEOZA?
can
VEOZA (fezolinetant) is a first-in-class, non-hormonal treatment targeting the NKB pathway in the thermoregulatory centre of the hypothalamus. By selectively blocking NK3 receptors, VEOZA restores temperature regulation and reduces VMS frequency and severity.1-3 Explore its clinical efficacy and patient-reported benefits.
What are VEOZA’s key benefits?
BENEFITS
MAT-NO-VEO-2025-00052 | Date of preparation 21.10.2025
Abbreviations & references
How effective is VEOZA at reducing VMS frequency?
EFFICACY: FREQUENCY
Back
Back
How effective is VEOZA at reducing VMS severity?
EFFICACY: SEVERITY
What patients expect from VEOZA?
can
What should I know about VEOZA’s safety profile?
SAFETY PROFILE
VEOZA (fezolinetant) is a first-in-class, non-hormonal treatment targeting the NKB pathway in the thermoregulatory centre of the hypothalamus. By selectively blocking NK3 receptors, VEOZA restores temperature regulation and reduces VMS frequency and severity.1-3 Explore its clinical efficacy and patient-reported benefits.
Can treating VMS positively impact sleep quality?
SLEEP IMPROVEMENT
more
Do you want information?
What are VEOZA’s key benefits?
BENEFITS
Get the latest updates and events related to VMS and VEOZA
MAT-NO-VEO-2025-00052 | Date of preparation 21.10.2025
Abbreviations & references
EFFICACY: FREQUENCY
Back
at
How effective is VEOZA reducing VMS frequency?
Can you guess....
In the SKYLIGHT 1 & 2 trials, VEOZA significantly reduced the average number of VMS episodes per day at Week 12.5 How many episodes were eliminated?
of women will experience VMS during the menopausal transition.1-4
Up to 80%
~2 out of 7 episodes
The frequency of
hot flushes varies greatly, from only a few times a month to
~3 out of 5 episodes
several times a day.3
~2 out of 3 episodes
~2 out of 4 episodes
Abbreviations & references
EFFICACY: FREQUENCY
Back
at
How effective is VEOZA reducing VMS frequency?
SKYLIGHT 1 & 2 overview
The efficacy of VEOZA was evaluated in two identical 12-week, randomised, placebo-controlled, double-blind Phase 3 studies (SKYLIGHT 1 & SKYLIGHT 2), followed by a 40-week non-placebo-controlled extension treatment period.1-3
Coprimary endpoints:1-3
Treatment gaps often go unnoticed until they widen. Explore the underlying gaps in VMS care.
TREATMENT GAPS
Learn more about the study design
Mean change from baseline to Week 4 and to Week 12 in:
- Moderate-severe VMS frequency
- Moderate-severe VMS severity
Study design
Participants
Secondary endpoints:2,3
The following were evaluated from baseline to Week 12:
- Mean change in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) total score
- Mean change in daily frequency and severity of moderate-severe VMS every week up to 12 weeks
- The proportion of women experiencing reductions of at least 50% and 75% in frequency of moderate-severe VMS
Inclusion & exclusion criteria
Abbreviations & references
EFFICACY: FREQUENCY
Back
at
How effective is VEOZA reducing VMS frequency?
VEOZA can help reduce your patients’ hot flushes and night sweats1-3
VMS frequency at Week 4
VMS frequency at Week 12
MEAN CHANGE FROM BASELINE
MEAN CHANGE FROM BASELINE
63%
53%
VEOZA
VEOZA
ELIMINATED
episodes by
REDUCED MODERATE TO SEVERE VMS
at Week 12 vs 40% with placebo.1
fewer VMS episodes
at Week 4 vs 32% with placebo.1
fewer VMS episodes
Title
Title
Use this side to give more information about a topic.
Use this side to give more information about a topic.
~2 out of every 3
Subtitle
Subtitle
LS mean change from baseline
LS mean change from baseline
53%
VMS episodes (63% reduction) at Week 12 vs 40% with placebo.1
See Week 4 results
See Week 12 results
at Week 4 vs 32% with placebo.1
Figures adapted from reference 1. LS mean: least square mean estimated from a mixed model for repeated measures analysis of covariance.1 Data contain a pooled analysis of SKYLIGHT 1 and SKYLIGHT 2.1 *Improvement compared with placebo, does not indicate statistical significance.4
Abbreviations & references
EFFICACY: FREQUENCY
Back
at
How effective is VEOZA reducing VMS frequency?
VEOZA provides sustained reduction in VMS frequency for up to 52 weeks1,2
Change in moderate to severe VMS up to Week 521,2
VEOZA showed a reduction in VMS episodes at Weeks 4 & 12, sustaining it through 52 weeks.1,2
VEOZA shows improvements in VMS frequency as early as Week 1.1,2
Switched to VEOZA 45 mg
AT WEEK 12
Reduction in frequency of VMS episodes was sustained through the study period.1,2
Patients initially in the placebo group who switched to VEOZA at Week 12 experienced similar long-term benefits.1,2
Figure adapted from references 1 and 2. Unpooled data from the Phase 3 studies SKYLIGHT 1 and SKYLIGHT 2.
Abbreviations & references
EFFICACY: SEVERITY
Back
at
How effective is VEOZA reducing VMS SEVERITY?
Can you guess....
VMS can vary in intensity, being mild, moderate, or severe.1
Compared to baseline, VEOZA significantly reduced the severity of remaining VMS episodes at 12 weeks.3
MILD
A sensation of heat without sweating.
VEOZA did not show a difference in VMS severity compared to placebo
MODERATE
A sensation of heat with sweating. Ability to continue with activities.
VEOZA shifted VMS severity from moderate-severe to mild-moderate
SEVERE
VEOZA shifted VMS severity from moderate-severe to moderate
A sensation of heat with sweating. Causes cessation of activities.
Patients taking VEOZA only reported improvement in night sweats
VMS last for a
median of 7.4 years2
Abbreviations & references
EFFICACY: SEVERITY
Back
at
How effective is VEOZA reducing VMS SEVERITY?
SKYLIGHT 1 & 2 overview
The efficacy of VEOZA was evaluated in two identical 12-week, randomised, placebo-controlled, double-blind Phase 3 studies (SKYLIGHT 1 & SKYLIGHT 2), followed by a 40-week non-placebo-controlled extension treatment period.1-3
Coprimary endpoints:1-3
Treatment gaps often go unnoticed until they widen. Explore the underlying gaps in VMS care.
TREATMENT GAPS
Learn more about the study design
Mean change from baseline to Week 4 and to Week 12 in:
- Moderate-severe VMS frequency
- Moderate-severe VMS severity
Study design
Participants
Secondary endpoints:2,3
The following were evaluated from baseline to Week 12:
- Mean change in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) total score
- Mean change in daily frequency and severity of moderate-severe VMS every week up to 12 weeks
- The proportion of women experiencing reductions of at least 50% and 75% in frequency of moderate-severe VMS
Inclusion & exclusion criteria
Abbreviations & references
EFFICACY: SEVERITY
Back
at
How effective is VEOZA reducing VMS SEVERITY?
VEOZA provides significant reductions in the severity of VMS compared to placebo1
- Sensation of heat
- Sweating
- Causing disruption to activity
Shift in symptom severity1-3
SEVERE2,3
mild- moderate
moderate- severe
From
To
- Sensation of heat
- Sweating
From a baseline score of 2.4, VEOZA reduced VMS severity to 1.9 at Week 4 and 1.7 at Week 12 compared with 2.1 and 2.0 on placebo, respectively.1-3
MODERATE2,3
Improvements at Weeks 4 & 12 vs placebo
MILD2,3
Figure adapted from references 1-3. *Data contain a pooled analysis of SKYLIGHT 1 and SKYLIGHT 2.1
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Adverse reactions
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1
Adverse reactions for VEOZA 45 mg1
Legend: Common (≥1/100 to <1/10); Not known (cannot be estimated from the available data).
MOST COMMON ADVERSE REACTIONS1
NO SAEs AT AN INCIDENCE >1% IN THE CLINICAL STUDIES1
The most common adverse reactions with VEOZA 45 mg were:1
Use this side of the card to provide more information about a topic. Focus on one concept. Make learning and communication more efficient.
There were no SAEs reported at an incidence greater than 1% across the total study population.1
Use this side of the card to provide more information about a topic. Focus on one concept. Make learning and communication more efficient.
Diarrhoea 3.2%
NO SAEs AT AN INCIDENCE >1% IN THE CLINICAL STUDIES1
MOST COMMON ADVERSE REACTIONS1
Title
On VEOZA, 4 SAEs were reported, the most serious one being endometrial adenocarcinoma (0.1%).1
Title
Write a brief description here
Insomnia 3.0%
Write a brief description here
Table adapted from reference 1. *See SmPC section 4.8.
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Adverse reactions
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1,2
Liver function tests must be performed prior to treatment initiation1,2
Before starting VEOZA Perform a baseline liver function test (LFT) prior to initiating treatment with VEOZA. Treatment should not be started if ALT ≥2× ULN or if total bilirubin is elevated (e.g. 2× ULN).
While using VEOZA Continue LFTs monthly for the first 3 months of treatment. Thereafter, additional monitoring may be conducted based on clinical judgement or when symptoms suggestive of liver injury occur.
Discontinue VEOZA if:
- Transaminase elevations are ≥3× ULN with: total bilirubin >2× ULN or if patients develop symptoms of liver injury
- Transaminase elevations >5× ULN
Patients should be informed about the signs and symptoms of liver injury and should be advised to contact their doctor immediately once these occur.
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Frequently reported TEAEs by preferred term (safety analysis set)2
Adverse reactions
Preferred term, n (%)
Placebo (n=952)
VEOZA (n=1,100)*
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1
TEAEs ≥2% in any group
Additional common TEAEs
Table adapted from reference 2. *The VEOZA group included participants who were re-randomised from placebo after 12 weeks on placebo from SKYLIGHT 1 and 2 studies.2
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Frequently reported TEAEs by preferred term (safety analysis set)2
Adverse reactions
Preferred term, n (%)
Placebo (n=952)
VEOZA (n=1,100)*
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1
TEAEs ≥2% in any group
Additional common TEAEs
Table adapted from reference 2. *The VEOZA group included participants who were re-randomised from placebo after 12 weeks on placebo from SKYLIGHT 1 and 2 studies.2
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Frequently reported TEAEs by preferred term (safety analysis set)2
Adverse reactions
Preferred term, n (%)
Placebo (n=952)
VEOZA (n=1,100)*
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1
TEAEs ≥2% in any group
Table adapted from reference 2. *The VEOZA group included participants who were re-randomised from placebo after 12 weeks on placebo from SKYLIGHT 1 and 2 studies.2
Additional common TEAEs
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Frequently reported TEAEs by preferred term (safety analysis set)2
Adverse reactions
Preferred term, n (%)
Placebo (n=952)
VEOZA (n=1,100)*
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1
TEAEs ≥2% in any group
Additional common TEAEs
Table adapted from reference 2. *The VEOZA group included participants who were re-randomised from placebo after 12 weeks on placebo from SKYLIGHT 1 and 2 studies.2
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Frequently reported TEAEs by preferred term (safety analysis set)2
Adverse reactions
Preferred term, n (%)
Placebo (n=952)
VEOZA (n=1,100)*
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1
TEAEs ≥2% in any group
Table adapted from reference 2. *The VEOZA group included participants who were re-randomised from placebo after 12 weeks on placebo from SKYLIGHT 1 and 2 studies.2
Additional common TEAEs
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
SKYLIGHT 4 overview
SKYLIGHT 4 was a randomised, placebo-controlled, double-blind, 52-week Phase 3 safety study of postmenopausal women, aged ≥40 to ≤65 years, seeking treatment for VMS.1
Primary endpoints1
Learn more about the study design
Frequency and severity of TEAEs
Study design
Percentage of participants with endometrial hyperplasia and endometrial malignancy
Participants
Inclusion & exclusion criteria
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Endometrial safety
304 postmenopausal women had baseline and
post-baseline endometrial biopsies during 52 weeks of treatment.1
In the long-term safety data (SKYLIGHT 1, 2, and 4), endometrial safety of VEOZA was assessed by transvaginal ultrasound and endometrial biopsies.1
Women were monitored for the following outcomes:1
Endometrial HYPERPLASIA or MALIGNANCY
Endometrial ADENOCARCINOMA
Endometrial THICKNESS
Endometrial HYPERPLASIA or MALIGNANCY
Endometrial ADENOCARCINOMA
Endometrial THICKNESS
NO INCREASED RISK
NO INCREASE
ONE CASE (0.1%)
Title
Title
Title
Use this side to give more information about a topic.
Use this side to give more information about a topic.
Use this side to give more information about a topic.
Subtitle
Subtitle
Subtitle
as revealed by endometrial biopsy assessments1
as revealed by transvaginal ultrasound1
of endometrial adenocarcinoma was observed2
References
SLEEP IMPROVEMENT
Back
Can treating VMS positively impact sleep quality?
Can you guess....
VMS are frequently associated with sleep disruption1,2
In the pooled results from SKYLIGHT 1 and 2, a higher proportion of participants receiving VEOZA reported positive change in sleep disturbance at Week 12 compared to placebo.7 Can you guess the proportion of women that reported “much better” sleep?
Did you know hot flushes and night sweats impacted sleep for
82%
of women who reported at least moderate VMS?3,*
Sleep disturbance can trigger further negative effects on women's QoL:
12.5%
Disturbed daily activities1
21.7%
Reduced work productivity1,4
Sleep disruption
Mood disturbance/depression4,5
27.8%
CVD6
32.4%
*From the MEPI Study of postmenopausal women 40 to 65 years old; N=1542 experiencing at least moderate VMS due to menopause.3
Abbreviations & references
SLEEP IMPROVEMENT
Back
Can treating VMS positively impact sleep quality?
VMS can disrupt daily life, with sleep quality being the most affected area for the majority of women going through menopause.1
VMS substantially impacted sleep, affecting
over 80% of women
while also interfering with mood and concentration.1,*
Figure adapted from reference 1. *In a study conducted among 2,703 postmenopausal women in the US aged 40–65 years. Women experiencing VMS of menopause in the previous 4 weeks were asked to identify the activities most affected by their symptoms.1
Abbreviations & references
SLEEP IMPROVEMENT
Back
Can treating VMS positively impact sleep quality?
VEOZA decreases sleep disturbance score and improves patient impression of sleep disturbance1-3
Change in patient-reported sleep disturbance
Sleep disturbance
SCORE
A greater decrease in patient-reported sleep disturbance was observed at Week 12 with VEOZA vs placebo.1-3
Sleep disturbance
CHANGES
Figure adapted from references 1-3.
*The mean change in the PROMIS SD SF 8b total score from the baseline to Week 12 was a key secondary endpoint in the SKYLIGHT trials.1-3 At the individual trial level, p-values were adjusted for multiplicity to control for type 1 error.1-3 Women were not enrolled into SKYLIGHT trials on the basis of sleep disturbance.1-3 †Adjusted for multiplicity.² ‡The pooled analysis of PROMIS SD SF 8b was prespecified and comes from an MMRM analysis of covariance model. The change from baseline is the dependent variable for PROMIS SD SF 8b. Pooled 95% CIs are for descriptive purposes only and are not adjusted for multiplicity. Outcomes among individual studies affect the outcome of the pooled analysis.³ §Distribution of the PGI-C SD at Weeks 4 and 12. PGI-C SD was an exploratory endpoint. Pooled data from SKYLIGHT 1 and 2.3 Data shown for the full analysis set (all randomised participants who received ≥1 dose of study intervention).3
Abbreviations & references
SLEEP IMPROVEMENT
Back
Can treating VMS positively impact sleep quality?
VEOZA decreases sleep disturbance score and improves patient impression of sleep disturbance1-3
Sleep disturbance
SCORE
Patient-reported changes in sleep disturbance3
A higher proportion of participants receiving VEOZA reported positive change in sleep disturbance compared with placebo as measured by PGI-C SD.3
27.8% of patients receiving VEOZA reported "much better" sleep at Week 12, compared to 15.4% on placebo.3
Sleep disturbance
CHANGES
Figure adapted from reference 3.
*The mean change in the PROMIS SD SF 8b total score from the baseline to Week 12 was a key secondary endpoint in the SKYLIGHT trials.1-3 At the individual trial level, p-values were adjusted for multiplicity to control for type 1 error.1-3 Women were not enrolled into SKYLIGHT trials on the basis of sleep disturbance.1-3 †Adjusted for multiplicity.² ‡The pooled analysis of PROMIS SD SF 8b was prespecified and comes from an MMRM analysis of covariance model. The change from baseline is the dependent variable for PROMIS SD SF 8b. Pooled 95% CIs are for descriptive purposes only and are not adjusted for multiplicity. Outcomes among individual studies affect the outcome of the pooled analysis.³ §Distribution of the PGI-C SD at Weeks 4 and 12. PGI-C SD was an exploratory endpoint. Pooled data from SKYLIGHT 1 and 2.3 Data shown for the full analysis set (all randomised participants who received ≥1 dose of study intervention).3
Abbreviations & references
SLEEP IMPROVEMENT
Back
Can treating VMS positively impact sleep quality?
VEOZA decreases sleep disturbance score and improves patient impression of sleep disturbance1-3
Change in patient-reported sleep disturbance
Sleep disturbance
SCORE
A greater decrease in patient-reported sleep disturbance was observed at Week 12 with VEOZA vs placebo.1-3
Sleep disturbance
CHANGES
Figure adapted from references 1-3.
*The mean change in the PROMIS SD SF 8b total score from the baseline to Week 12 was a key secondary endpoint in the SKYLIGHT trials.1-3 At the individual trial level, p-values were adjusted for multiplicity to control for type 1 error.1-3 Women were not enrolled into SKYLIGHT trials on the basis of sleep disturbance.1-3 †Adjusted for multiplicity.² ‡The pooled analysis of PROMIS SD SF 8b was prespecified and comes from an MMRM analysis of covariance model. The change from baseline is the dependent variable for PROMIS SD SF 8b. Pooled 95% CIs are for descriptive purposes only and are not adjusted for multiplicity. Outcomes among individual studies affect the outcome of the pooled analysis.³ §Distribution of the PGI-C SD at Weeks 4 and 12. PGI-C SD was an exploratory endpoint. Pooled data from SKYLIGHT 1 and 2.3 Data shown for the full analysis set (all randomised participants who received ≥1 dose of study intervention).3
Abbreviations & references
BENEFITS
Back
WHAT ARE VEOZA’s key benefits?
VEOZA is a non-hormonal treatment option for your patients1,2
Here’s how VEOZA may help women experiencing VMS:
Non-hormonal treatment1,2
Reduction in VMS frequency and severity as early as Week 13,4
Positive impact on sleep5
Once-daily oral dosing at the time that suits your patient best6
For VEOZA, the most common adverse reactions were diarrhoea (3.2%) and insomnia (3.0%).7
Remember: Liver function tests must be performed at baseline and monthly during the first 3 months of treatment and thereafter on clinical judgement.8,*
*In clinical studies, ALT >3× ULN was observed in 2.1% of women on VEOZA (vs 0.8% on placebo) and AST >3× was observed in 1% of women on VEOZA (vs 0.45% on placebo).7
Abbreviations & references
BENEFITS
Back
WHAT ARE VEOZA’s key benefits?
Watch how VEOZA can be beneficial for your patients:
Back
when
What to consider prescribing VEOZA?
VEOZA is administered once daily, at about the same time each day, offering dosing flexibility for patients.1 This section provides guidance on dosing, administration, and precautions to support appropriate prescribing and patient monitoring.
What is the recommended dosing and administration regimen?
DOSING & ADMINISTRATION
What considerations apply when prescribing VEOZA?
PRECAUTIONS
MAT-NO-VEO-2025-00050 | Date of preparation 21.10.2025
Abbreviations & references
Back
when
What to consider prescribing VEOZA?
VEOZA is administered once daily, at about the same time each day, offering dosing flexibility for patients.1 This section provides guidance on dosing, administration, and precautions to support appropriate prescribing and patient monitoring.
more
Do you want information?
Get the latest updates and events related to VMS and VEOZA
What is the recommended dosing and administration regimen?
DOSING & ADMINISTRATION
What considerations apply when prescribing VEOZA?
PRECAUTIONS
MAT-NO-VEO-2025-00050 | Date of preparation 21.10.2025
Abbreviations & references
DOSING & ADMINISTRATION
Back
and
What is the recommended dosing administration regimen?
1 tablet* a day – once daily, at her convenience1,2
VEOZA is indicated for the treatment of moderate to severe VMS associated with menopause.3,†
Long-term assessment
If a dose is missed or not taken at the usual time, the missed dose should be taken as soon as possible, unless there are fewer than 12 hours before the next scheduled dose.1 Patients should return to the regular schedule the following day.1
Use this side of the card to provide more information about a topic. Focus on one concept. Make learning and communication more efficient.
Use this side of the card to provide more information about a topic. Focus on one concept. Make learning and communication more efficient.
Use this side of the card to provide more information about a topic. Focus on one concept. Make learning and communication more efficient.
Benefit of long-term treatment should be periodically assessed since the duration of VMS can vary by individual.1
VEOZA can be taken with or without food and should be taken with liquids and swallowed whole. The tablet should not be broken, crushed, or chewed.1
VEOZA is taken once daily, at about the same time each day, adapted to each woman's individual schedule and preferences.1
VEOZA 45 mg is taken orally
One dose whenever it suits her the best
About the same time, every day
Title
Title
Title
Write a brief description here
Write a brief description here
Write a brief description here
*Round tablet, 7 mm diameter × 3 mm thickness.2 †See section 5.1 in SmPC.
Abbreviations & references
PRECAUTIONS
Back
when
What considerations apply prescribing VEOZA?
Special warnings and precautions for use
The following contraindications and precautions should be considered when prescribing VEOZA.
Contraindications
special populations
- Hypersensitivity to the active substance or to any of the excipients1
- Concomitant use of moderate or strong CYP1A2 inhibitors2,3
- Known or suspected pregnancy. If pregnancy occurs during use of VEOZA, treatment should be withdrawn immediately1,3
- VEOZA is not recommended for use in individuals with severe (eGFR less than 30 mL/min/1.73 m2) renal impairment or Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment4
Abbreviations & references
PRECAUTIONS
Back
when
What considerations apply prescribing VEOZA?
Safety considerations
When the patient is using VEOZA, review the safety assessments and monitoring requirements.
BEFORE
Perform a baseline liver function test (LFT) prior to initiating treatment with VEOZA
starting VEOZA
Treatment should not be initiated/started if ALT or AST levels are ≥2× ULN or if total bilirubin is increased (e.g., ≥2× ULN)1,2
using VEOZA
WHILE
Abbreviations & references
PRECAUTIONS
Back
when
What considerations apply prescribing VEOZA?
Safety considerations
When the patient is using VEOZA, review the safety assessments and monitoring requirements.
starting VEOZA
BEFORE
Continue to monitor LFTs monthly for the first 3 months of treatment
Discontinue VEOZA if:
- Transaminase elevations are ≥3× ULN with: total bilirubin >2× ULN OR if patients develop symptoms of liver injury1,2
- Transaminase elevations >5× ULN1,2
Thereafter, additional monitoring may be conducted based on clinical judgement or when symptoms suggestive of liver injury occur1,2
WHILE
Patients should be informed about the signs and symptoms of liver injury and should be advised to contact their doctor immediately in case these occur.1,2
using VEOZA
Abbreviations & references
PRECAUTIONS
Back
when
What considerations apply prescribing VEOZA?
Safety considerations
When the patient is using VEOZA, review the safety assessments and monitoring requirements.
BEFORE
Perform a baseline liver function test (LFT) prior to initiating treatment with VEOZA
starting VEOZA
Treatment should not be initiated/started if ALT or AST levels are ≥2× ULN or if total bilirubin is increased (e.g., ≥2× ULN)1,2
using VEOZA
WHILE
Abbreviations & references
Abbreviations VMS, vasomotor symptoms. References 1. Constantine GD, Graham S, Clerinx C, Bernick BA, Krassan M, Mirkin S, et al. Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries. Post Reprod Health. 2016 Sep;22(3):112–22. 2. Barber K, Charles A. Barriers to Accessing Effective Treatment and Support for Menopausal Symptoms: A Qualitative Study Capturing the Behaviours, Beliefs and Experiences of Key Stakeholders. Patient Prefer Adherence. 2023 Nov 15;17:2971–80.
NOT CORRECT!
By Week 12, 27.8% of women reported “much better” sleep vs 15.4% on placebo, as measured by the Patient Global Impression of Change in Sleep Disturbance (PGI-C SD).7
PGI-C SD was an exploratory endpoint.7
See more in next slides
12.5%
NOT CORRECT!
By Week 12, 27.8% of women reported “much better” sleep vs 15.4% on placebo, as measured by the Patient Global Impression of Change in Sleep Disturbance (PGI-C SD).7
PGI-C SD was an exploratory endpoint.7
See more in next slides
32.4%
Abbreviations VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.2 03.2025.
Figure adapted from reference 1.
Central nervous system
Central nervous system1
Sleep disruption
Depression and anxiety
Cognitive performance changes
Migraine
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 4. Kaunitz AM, Manson JE. Management of Menopausal Symptoms. Obstet Gynecol. 2015 Oct;126(4):859-76. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 6. Medicines and related procedures [Internet]. [Cited 2025 Aug 27]. Available from: https://www.ema.europa.eu/en/search?search_api_fulltext=menopause
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 4. Kaunitz AM, Manson JE. Management of Menopausal Symptoms. Obstet Gynecol. 2015 Oct;126(4):859-76. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 6. Medicines and related procedures [Internet]. [Cited 2025 Aug 27]. Available from: https://www.ema.europa.eu/en/search?search_api_fulltext=menopause
CORRECT!
VEOZA reduced VMS severity from moderate-severe to mild-moderate at Week 12.
VEOZA shifted VMS severity from moderate-severe to mild-moderate
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -0.67 [(SE 0.04) from baseline (2.40; SD 0.35)] vs -0.42 for the placebo group [(SE 0.04) from baseline (2.42; SD 0.34)].3
See more in next slides
Abbreviations CI, confidence interval; LS, least squares; MMRM, mixed-model for repeated measures; PGI-C SD, Patient Global Impression of Change in Sleep Disturbance; PROMIS SD SF, Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form Questionnaire; VMS, vasomotor symptoms. References 1. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 2. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 3. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
References 1. Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199–215. 2. Santoro NF. Menopause. In: Crandall CJ, Bachman GA, Faubion SS, Klein W, Liu JH, Manson JE, et al, editors. Menopause practice: a clinician’s guide. 6th ed. Pepper Pike (OH): The North American Menopause Society; 2019. p. 1–23. 3. Davis SR, Lambrinoudaki I, Lumsden M, Mishra GD, Pal L, Rees M, et al. Menopause. Nat Rev Dis Primers. 2015 Apr 23;1:15004. 4. Malmberg C, Althin R, Olofsson S. Productivity loss related to vasomotor symptoms (VMS) during menopausal transition among women in the Nordics. IHE-The Swedish Institute for Health Economics; 2024. 5. Harlow SD, Gass M, Hall JE, Lobo R, Maki P, Rebar RW, et al. Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. J Clin Endocrinol Metab. 2012 Apr;97(4):1159–68. 6. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 7. Kuck MJ, Hogervorst E. Stress, depression, and anxiety: psychological complaints across menopausal stages. Front Psychiatry. 2024 Feb 22;15:1323743. 8. Santoro N, Roeca C, Peters BA, Neal-Perry G. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021 Jan 1;106(1):1–15. 9. Gold EB. The timing of the age at which natural menopause occurs. Obstet Gynecol Clin North Am. 2011 Sep;38(3):425–40. 10. Shuster LT, Rhodes DJ, Gostout BS, Grossardt BR, Rocca WA. Premature menopause or early menopause: long-term health consequences. Maturitas. 2010 Feb;65(2):161–6. 11. Swanner KD, Richmond LB. A 65-Year-Old Woman With No Menopause History: A Case Report. Cureus. 2023 Sep 6;15(9):e44792.
References 1. VEOZA SmPC §5.1 03.2025. 2. VEOZA SmPC §4.8 03.2025.
Abbreviations ALP, alkaline phosphatase; COVID-19, coronavirus disease 2019; CPK, creatine phosphokinase; TEAE, treatment emergent adverse event. References 1. VEOZA SmPC §4.8 03.2025. 2. Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147–64.
Increased healthcare utilisation7
- Untreated VMS can lead to higher healthcare utilisation, including ~80% more outpatient visits compared to controls in one study.7
- A US study found that annual direct healthcare costs were about US$1,350 higher per woman with untreated VMS compared to controls.7
VMS
Increased healthcare utilisation7
NOT CORRECT!
VEOZA reduced VMS severity from moderate-severe to mild-moderate at Week 12.
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -0.67 [(SE 0.04) from baseline (2.40; SD 0.35)] vs -0.42 for the placebo group [(SE 0.04) from baseline (2.42; SD 0.34)].3
Patients taking VEOZA only reported improvement in night sweats
See more in next slides
Abbreviations QoL, quality of life; VMS, vasomotor symptoms. References 1. Zhu D, Chung HF, Dobson AJ, Pandeya N, Giles GG, Bruinsma F, et al. Age at natural menopause and risk of incident cardiovascular disease: a pooled analysis of individual patient data. Lancet Public Health. 2019 Nov 1;4(11):e553–64. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Malmberg C, Althin R, Olofsson S. Productivity loss related to vasomotor symptoms (VMS) during menopausal transition among women in the Nordics. IHE-The Swedish Institute for Health Economics; 2024. 4. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 5. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 6. POPU01: Population 1 January by unit, reporting country, age, sex and time [Internet]. [Cited 2025 Jul 18]. Available from: https://pxweb.nordicstatistics.org/pxweb/en/Nordic%20Statistics/Nordic%20Statistics__Demography__Population%20size/POPU01.px/?rxid=4bd7ba15-3c4a-4793-8711-6db1fc878223
Sleep disturbance3-6
4,6
6,13
Sleep disturbance
Reduced work productivity3,5,7
Mood disturbance / depression3-5
VMS and sleep
- Hot flushes are strongly correlated with insomnia and poor sleep.3,4,6
- In one study, 93.8% of women with moderate to severe VMS reported sleep interruptions from overheating and difficulty returning to sleep.5
Sleep disturbance subsequently can affect mood, work productivity, and daily and social activities, and is shown to be correlated to increased cardiovascular risk.4,6,14,15
Reversely, work strain and impaired mood may also worsen sleep6,15 — click on each to learn more.
14
13
Daily activities3,5
CVD11,12
VMS
Footnotes §MILDER EPISODES: The pooled result showed a reduction in VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 ¶STUDIED SAFETY PROFILE FOR VMS: The safety of VEOZA was evaluated in Phase 3 clinical studies with 2203 postmenopausal women and from spontaneous reporting in clinical practice.5 Abbreviations BMI, body mass index; CV, cardiovascular; KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SAE, serious adverse event; SD, standard deviation; SE, standard error; TEAE, treatment-emergent adverse event; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. VEOZA SmPC §4.8 03.2025.
Abbreviations NKB, neurokinin B; NK3R, neurokinin 3 receptor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.1 03.2025. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Jayasena CN, Comninos AN, Stefanopoulou E, Buckley A, Narayanaswamy S, Izzi-Engbeaya C, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015 Feb 16;5:8466.
Sleep disturbance3-6
Daily activities3,5
- In one study, moderate to severe VMS affected daily activities in about 50% of US women and 44% of EU women.5
- A 2025 Nordic study showed that moderate to severe VMS reduced daily activities by 30.6%.3
Women with inadequate sleep related to VMS report being slower, struggling with tasks, and feeling tired during the day5 — click on each to learn more.
Daily activities3,5
VMS
NOT CORRECT!
VMS often persists longer than that, with a median persistence of 7.4 years.1 VMS varies widely among women, but prevalence generally peaks within the first two years after the final menstrual period.2
Learn more in the section: Menopause.
5.6 years
NOT CORRECT!
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -6.94 [(SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].5
See more in next slides
VEOZA reduced the average daily frequency of hot flushes and night sweats by 63%.
~2 out of 4 episodes
Abbreviations VMS, vasomotor symptoms. References 1. Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachman GA, Faubion SS, Klein W, Liu JH, Manson JE, et al, editors. Menopause practice: a clinician’s guide. 6th ed. Pepper Pike (OH): The North American Menopause Society; 2019. p. 43–55. 2. Mishra GD, Dobson AJ. Using longitudinal profiles to characterize women's symptoms through midlife: results from a large prospective study. Menopause. 2012 May;19(5):549–55. 3. Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr 1;175(4):531–9.
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94.
Abbreviations CVD, cardiovascular disease; MEPI, Menopause Epidemiology; PGI-C SD, Patient Global Impression of Change in Sleep Disturbance; QoL, quality of life; VMS, vasomotor symptoms. References 1. Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005 Aug 5;3:47. 2. English M, Stoykova B, Slota C, Doward L, Siddiqui E, Crawford R, et al. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS sleep disturbance and sleep-related impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes. 2021 Apr 26;5(1):37. 3. Williams RE, Levine KB, Kalilani L, Lewis J, Clark RV. Menopause-specific questionnaire assessment in US population-based study shows negative impact on health-related quality of life. Maturitas. 2009 Feb 20;62(2):153–9. 4. Baker FC, Lampio L, Saaresranta T, Polo-Kantola P. Sleep and sleep disorders in the menopausal transition. Sleep Med Clin. 2018 Sep;13(3):443–56. 5. Lett HS, Blumenthal JA, Babyak MA, Sherwood A, Strauman T, Robins C, et al. Depression as a risk factor for coronary artery disease: evidence, mechanisms, and treatment. Psychosom Med. 2004 May–Jun;66(3):305–15. 6. Cappuccio FP, Cooper D, D'Elia L, Strazzullo P, Miller MA. Sleep duration predicts cardiovascular outcomes: a systematic review and meta-analysis of prospective studies. Eur Heart J. 2011 Jun 1;32(12):1484–92. 7. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
Cognition impairment4,5 and CNS alterations9,10
- Hot flushes and related sleep disturbance can interfere with memory, focus, and concentration.5
- During a hot flush, blood flow decreases in the hippocampus, possibly impairing memory and cognition.4
- Hot flushes are linked to physical changes in memory-related brain networks in the hippocampus.9
- Night sweats are associated with greater white matter hyperintensities, which are linked to stroke, cognitive decline, dementia, and increased mortality.10
VMS
Cognition impairment4,5 and CNS alterations9,10
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. VEOZA SmPC §4.1 03.2025.
Abbreviations VMS, vasomotor symptoms. References 1. Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199–215. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89.
NOT CORRECT!
VMS are very common, affecting up to
80% of women during the menopausal transition.1,2
Learn more in the section: Life with VMS.
Up to 5 in 10 women experience VMS
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 4. Kaunitz AM, Manson JE. Management of Menopausal Symptoms. Obstet Gynecol. 2015 Oct;126(4):859-76. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 6. Medicines and related procedures [Internet]. [Cited 2025 Aug 27]. Available from: https://www.ema.europa.eu/en/search?search_api_fulltext=menopause
CORRECT!
KNDy neurons become hyperactive due to loss of oestrogen inhibition, which overstimulates the thermoregulatory centre in the hypothalamus. This triggers VMS and provides a basis for developing targeted non-hormonal therapies.1-3
Learn more in the section: Mechanism of VMS.
They become hyperactive due to loss of oestrogen inhibition, disrupting thermoregulation
PERIMENOPAUSE
This phase involves endocrine, physical, and temporary psychologic changes. It is marked by a decreasing number of ovarian follicles, which leads to changes in the menstrual pattern.2,5 During this phase, women experience:
- Hormonal fluctuations, beginning years before the final menstrual period.5,8
- Irregular menstrual cycles.5,8
- VMS, sleep disturbances, mood changes, and other symptoms.1,8
Early perimenopause Irregular menstrual bleeding of consecutive menstrual cycles.5
Late perimenopause When menstrual bleeding has not occurred in the last 60 days, but has happened in the previous 12 months.5
Figure adapted from reference 4.
perimenopause
35-45 yr Last regular menstrual cycle
12 months with amenorrhoea
Footnotes §MILDER EPISODES: The pooled result showed a reduction in VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 ¶STUDIED SAFETY PROFILE FOR VMS: The safety of VEOZA was evaluated in Phase 3 clinical studies with 2203 postmenopausal women and from spontaneous reporting in clinical practice.5 Abbreviations BMI, body mass index; CV, cardiovascular; KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SAE, serious adverse event; SD, standard deviation; SE, standard error; TEAE, treatment-emergent adverse event; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. VEOZA SmPC §4.8 03.2025.
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.4,5 §SIGNIFICANT EFFECT FROM WEEK 4: The pooled results from SKYLIGHT 1 and 2 demonstrated a clinically meaningful decrease from baseline at Week 4 compared to placebo (reduction of 2 or more VMS episodes per 24h; p<0.001). At Week 4, patients experienced a 52.84% reduction in the average daily frequency of hot flushes and night sweats in the VEOZA group [-5.79 (SE 0.23) from baseline 11.10 (SD 6.45)] compared to a 31.96% reduction in the placebo group [-3.51 (SE 0.22) from baseline 11.04 (SD 4.46)].2 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; VMS, vasomotor symptoms. References 1. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 5. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
NOT CORRECT!
VMS are very common, affecting up to
80% of women during the menopausal transition.1,2
Learn more in the section: Life with VMS.
Up to 2 in 10 women experience VMS
Abbreviations VMS, vasomotor symptoms.
NOT CORRECT!
VMS often persists longer than that, with a median persistence of 7.4 years.1 VMS varies widely among women, but prevalence generally peaks within the first two years after the final menstrual period.2
Learn more in the section: Menopause.
4.8 years
Abbreviations BLN, baseline; SE, standard error; VMS, vasomotor symptoms. References 1. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 2. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
Abbreviations QoL, quality of life; VMS, vasomotor symptoms. References 1. Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr 1;175(4):531–9. 2. Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause. 2014 Sep 1;21(9):924–32. 3. Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Granger AL, Fehnel SE, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Climacteric. 2008 Feb;11(1):32–43. 4. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 5. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86.
MENOPAUSE
Menopause is a significant milestone that marks the end of a woman’s reproductive years.2
- Clinical definition: Menopause is marked by the final menstrual period, diagnosed retrospectively after 12 months of amenorrhoea2
- Age variability: Onset range varies across different populations9
Premature menopause10
Early menopause10,11
Typical onset of menopause10,11
Late menopause11
51
5%
1%
5%
of women
of women
of women
average age
Age
<40
45
51
>55
Figure adapted from reference 4.
menopause
51 yr on average Final menstrual period
Abbreviations QoL, quality of life; VMS, vasomotor symptoms. References 1. Zhu D, Chung HF, Dobson AJ, Pandeya N, Giles GG, Bruinsma F, et al. Age at natural menopause and risk of incident cardiovascular disease: a pooled analysis of individual patient data. Lancet Public Health. 2019 Nov 1;4(11):e553–64. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Malmberg C, Althin R, Olofsson S. Productivity loss related to vasomotor symptoms (VMS) during menopausal transition among women in the Nordics. IHE-The Swedish Institute for Health Economics; 2024. 4. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 5. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 6. POPU01: Population 1 January by unit, reporting country, age, sex and time [Internet]. [Cited 2025 Jul 18]. Available from: https://pxweb.nordicstatistics.org/pxweb/en/Nordic%20Statistics/Nordic%20Statistics__Demography__Population%20size/POPU01.px/?rxid=4bd7ba15-3c4a-4793-8711-6db1fc878223
Study design2,3,*
Fezolinetant 30 mg
Placebo
Fezolinetant 45 mg
Visit:End of treatment
Randomisation 1:1:1 n=1,022
Visit:Follow-up
Screening
Fezolinetant 30 mg
Fezolinetant 30 mg
Fezolinetant 45 mg
Fezolinetant 45 mg
DAY 1
WEEK 4
WEEK 12
40-WEEK EXTENSION
WEEK 52
WEEK 55
Figure adapted from references 2 and 3. *The study design includes 30 mg arms to be consistent with SKYLIGHT 1 and SKYLIGHT 2. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to the 45 mg dose.
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94.
Inclusion and exclusion criteria1-3
Inclusion criteria:
Exclusion criteria:
- Born female, aged ≥40 years to ≤65 years at screening
- BMI ≥18 kg/m2 to ≤38 kg/m2
- Seeking treatment or relief for vasomotor symptoms associated with menopause and at screening having spontaneous amenorrhoea for ≥12 consecutive months; spontaneous amenorrhoea for ≥6 months with biochemical criteria of menopause (follicle-stimulating hormone >40 IU/L); or had bilateral oophorectomy ≥6 weeks before screening
- Within 10 days before randomisation, women should have a minimum average of 7 to 8 moderate to severe hot flushes (VMS) per day, or 50 to 60 per week
- Normal, negative, or no clinically significant findings on mammogram within the previous 12 months or at screening
- Normal or not clinically significant Papanicolaou test result within the previous 12 months, or at screening
- Willing to undergo a transvaginal ultrasound to evaluate the uterus and ovaries at screening and at Week 52 (end of treatment), and at early discontinuation for women who withdraw from the study before completion
- Willing to undergo an endometrial biopsy at screening and at Week 52 (end of treatment) unless they’ve had a supracervical or full hysterectomy; the endometrial biopsy obtained at screening should be considered evaluable, and they should be willing to undergo an endometrial biopsy in case of uterine bleeding or early discontinuation of the study or study drug
- Receiving strong or moderate CYP1A2 inhibitors, hormone replacement therapy, hormonal contraceptive, or any treatment for Vasomotor Symptoms (prescription, over the counter, or herbal)
- Previous or existing history of a malignant tumour, except for basal cell carcinoma
- Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg based on an average of 2 or 3 readings on at least two different occasions within the screening period; women who did not meet these criteria might, at the discretion of the investigator, be reassessed after initiation or review of antihypertensive measures; women with a medical history of hypertension could be enrolled at the discretion of the investigator once they were medically clear (stable and compliant)
- History within the past 6 months of undiagnosed uterine bleeding
- A medical condition or chronic disease (e.g., history of neurological [e.g., cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [e.g., moderate asthma], endocrine, or gynaecological disease) or malignancy that could confound interpretation of the study
- Active liver disease, jaundice, or elevated liver aminotransferases (alanine aminotransferase or aspartate aminotransferase), elevated total or direct bilirubin, elevated international normalised ratio, or elevated alkaline phosphatase
- Creatinine more than 1.5 times the upper limit of normal; or estimated glomerular filtration rate ≤59 mL/min/1.73 m² at screening
Abbreviations BMI, body mass index; TEAE, treatment emergent adverse event; VMS, vasomotor symptoms. References 1. Neal-Perry G, Cano A, Lederman S, Nappi RE, Santoro N, Wolfman W, et al. Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial. Obstet Gynecol. 2023 Apr 1;141(4):737–47.
Abbreviations VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.2 03.2025.
Abbreviations NKB, neurokinin B; NK3R, neurokinin 3 receptor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.1 03.2025. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Jayasena CN, Comninos AN, Stefanopoulou E, Buckley A, Narayanaswamy S, Izzi-Engbeaya C, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015 Feb 16;5:8466.
Abbreviations ALP, alkaline phosphatase; COVID-19, coronavirus disease 2019; CPK, creatine phosphokinase; TEAE, treatment emergent adverse event. References 1. VEOZA SmPC §4.8 03.2025. 2. Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147–64.
Sleep disturbance3-6
6,13
CVD11,12
Mood disturbance / depression3-5
VMS and cardiovascular health
- Hot flushes are associated with poorer endothelial function and greater aortic calcification, independent of CVD risk factors and sex hormone status.11
- VMS are related to higher carotid intima media thickness and carotid plaque, independent of standard risk factors and sex hormones.11,12
Sleep disturbances, such as short sleep duration, are associated with increased risk of CVD and CVD related mortality14 — click on each to learn more.
14
13
CVD11,12
VMS
PREMENOPAUSE
Premenopause includes the reproductive stages (early, peak, and late), and the menopausal transition (early and late).5 Up until perimenopause, women present:
- Regular, high oestrogen levels that fluctuate with each cycle6
- Consistent menstrual cycles within the past three months2,7
- Predictable hormonal patterns and active reproductive capacity3
Figure adapted from reference 4.
Premenopause
11-15 yr Menarche
Abbreviations Avg., average; VMS, vasomotor symptoms. References 1. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 2. Nordic Cooperation. 10 facts about gender equality [Internet]. Copenhagen: Nordic Council of Ministers; [cited 2025 Jul 28]. Available from: https://www.norden.org/en/information/10-facts-about-gender-equality 3. Department for Work and Pensions. Menopause and the workplace: How to enable fulfilling working lives – government response [Internet]. London: GOV.UK; 2022 Jul [updated 2022 Jul; cited 2025 Aug 18]. Available from: https://www.gov.uk/government/publications/menopause-and-the-workplace-how-to-enable-fulfilling-working-lives-government-response/menopause-and-the-workplace-how-to-enable-fulfilling-working-lives-government-response 4. Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199–215. 5. Larsen M, Holt H, Larsen MR. Et kønsopdelt arbejdsmarked [Internet]. Copenhagen: VIVE – The Danish Center for Social Science Research; 2016 [cited 2025 Aug 18]. Available from: https://pure.vive.dk/ws/files/416934/1615_Et_k_nsdopdelt_arbejdsmarked.pdf 6. Malmberg C, Althin R, Olofsson S. Productivity loss related to vasomotor symptoms (VMS) during menopausal transition among women in the Nordics. IHE-The Swedish Institute for Health Economics; 2024.
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Rance NE, Dacks PA, Mittelman-Smith MA, Romanovsky AA, Krajewski-Hall SJ. Modulation of body temperature and LH secretion by hypothalamic KNDy (kisspeptin, neurokinin B and dynorphin) neurons: a novel hypothesis on the mechanism of hot flushes. Front Neuroendocrinol. 2013 Aug;34(3):211–27. 3. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132.
CORRECT!
VMS has a median persistence of 7.4 years.1 VMS varies widely among women, but prevalence generally peaks within the first two years after the final menstrual period.2
Learn more in the section: Menopause.
7.4 years
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 4. Kaunitz AM, Manson JE. Management of Menopausal Symptoms. Obstet Gynecol. 2015 Oct;126(4):859-76. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 6. Medicines and related procedures [Internet]. [Cited 2025 Aug 27]. Available from: https://www.ema.europa.eu/en/search?search_api_fulltext=menopause
NOT CORRECT!
A study showed that 43–50% of women with menopausal symptoms do not seek any treatment, depending on the country, highlighting the large treatment gap in menopause care. Many women avoid seeking care due to discomfort discussing symptoms or embarrassment.1,2
Learn more in the section: Treatment options.
Around 3/4 of women
Epigenetic ageing8
- Among postmenopausal women, severe or late-occurring VMS are associated with accelerated epigenetic ageing.8
- Accelerated epigenetic ageing is linked to cancers, reduced physical function, higher risk of major diseases, and all-cause mortality.8
VMS
Epigenetic ageing8
Physical health5
NOT CORRECT!
A study showed that 43–50% of women with menopausal symptoms do not seek any treatment, depending on the country, highlighting the large treatment gap in menopause care. Many women avoid seeking care due to discomfort discussing symptoms or embarrassment.1,2
Learn more in the section: Treatment options.
Almost every woman
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94.
Abbreviations HCPs, healthcare professionals; VMS, vasomotor symptoms. References 1. DePree B, Houghton K, Shiozawa A, Esterberg E, King DD, Kim J, et al. Treatment and resource utilization for menopausal symptoms in the United States: a retrospective review of real-world evidence from US electronic health records. Menopause. 2023 Jan 1;30(1):70–9. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Barber K, Charles A. Barriers to Accessing Effective Treatment and Support for Menopausal Symptoms: A Qualitative Study Capturing the Behaviours, Beliefs and Experiences of Key Stakeholders. Patient Prefer Adherence. 2023 Nov 15;17:2971–80. 4. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 5. Constantine GD, Graham S, Clerinx C, Bernick BA, Krassan M, Mirkin S, et al. Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries. Post Reprod Health. 2016 Sep;22(3):112–22. 6. Dintakurti N, Kalyanasundaram S, Jha P, Talaulikar V. An online survey and interview of GPs in the UK for assessing their satisfaction regarding the medical training curriculum and NICE guidelines for the management of menopause. Post Reprod Health. 2022 Sep;28(3):137–41.
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94.
NOT CORRECT!
KNDy neurons become hyperactive due to loss of oestrogen inhibition, which overstimulates the thermoregulatory centre in the hypothalamus. This triggers VMS and provides a basis for developing targeted non-hormonal therapies.1-3
Learn more in the section: Mechanism of VMS.
They respond to temperature changes by regulating norepinephrine release
Muscoskeletal system
Musculoskeletal system1
Joint pain
Sarcopenia (loss of muscle mass)
Abbreviations ALP, alkaline phosphatase; COVID-19, coronavirus disease 2019; CPK, creatine phosphokinase; TEAE, treatment emergent adverse event. References 1. VEOZA SmPC §4.8 03.2025. 2. Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147–64.
Abbreviations VMS, vasomotor symptoms. References 1. Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachmann GA, Faubion SS, et al. Menopause practice: a clinician’s guide. 6th ed. Pepper Pike (OH): The North American Menopause Society; 2019. p. 43–55. 2. Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr 1;175(4):531–9. 3. VEOZA SmPC §5.1 03.2025.
Abbreviations QoL, quality of life; VMS, vasomotor symptoms. References 1. Zhu D, Chung HF, Dobson AJ, Pandeya N, Giles GG, Bruinsma F, et al. Age at natural menopause and risk of incident cardiovascular disease: a pooled analysis of individual patient data. Lancet Public Health. 2019 Nov 1;4(11):e553–64. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Malmberg C, Althin R, Olofsson S. Productivity loss related to vasomotor symptoms (VMS) during menopausal transition among women in the Nordics. IHE-The Swedish Institute for Health Economics; 2024. 4. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 5. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 6. POPU01: Population 1 January by unit, reporting country, age, sex and time [Internet]. [Cited 2025 Jul 18]. Available from: https://pxweb.nordicstatistics.org/pxweb/en/Nordic%20Statistics/Nordic%20Statistics__Demography__Population%20size/POPU01.px/?rxid=4bd7ba15-3c4a-4793-8711-6db1fc878223
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 4. Kaunitz AM, Manson JE. Management of Menopausal Symptoms. Obstet Gynecol. 2015 Oct;126(4):859-76. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 6. Medicines and related procedures [Internet]. [Cited 2025 Aug 27]. Available from: https://www.ema.europa.eu/en/search?search_api_fulltext=menopause
Physical health5
- VMS are often accompanied by physical symptoms such as dizziness, nausea, headaches, or ringing in the ears, followed by a feeling of being physically drained.5
VMS are also linked to accelerated epigenetic aging, which in turn is associated with higher risk of cancers, reduced physical function, Alzheimer’s disease, coronary heart disease, and all-cause mortality8 — click on each to learn more.
VMS
Epigenetic ageing8
Physical health5
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.4,5 §SIGNIFICANT EFFECT FROM WEEK 4: The pooled results from SKYLIGHT 1 and 2 demonstrated a clinically meaningful decrease from baseline at Week 4 compared to placebo (reduction of 2 or more VMS episodes per 24h; p<0.001). At Week 4, patients experienced a 52.84% reduction in the average daily frequency of hot flushes and night sweats in the VEOZA group [-5.79 (SE 0.23) from baseline 11.10 (SD 6.45)] compared to a 31.96% reduction in the placebo group [-3.51 (SE 0.22) from baseline 11.04 (SD 4.46)].2 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; VMS, vasomotor symptoms. References 1. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 5. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
Social / relationship4,5
- VMS can negatively affect relationships and may lead to avoidance of physical intimacy.5
- In one study, more than two thirds of EU women restricted their social activities due to VMS, including the events they attended and the time of year they chose to take vacations.5
- Women report strained relationships with coworkers, family, and especially partners due to VMS.5
- Becoming flushed and sweating in a social or work setting may cause anxiety and lead to social isolation.4
Sleep disturbance and irritability caused by VMS can strain familial and social relationships4 — click on each to learn more.
VMS
Social / relationship4,5
NOT CORRECT!
KNDy neurons become hyperactive due to loss of oestrogen inhibition, which overstimulates the thermoregulatory centre in the hypothalamus. This triggers VMS and provides a basis for developing targeted non-hormonal therapies.1-3
Learn more in the section: Mechanism of VMS.
They stimulate sweat glands directly through autonomic pathways
Inclusion and exclusion criteria1-3
Inclusion criteria:
Exclusion criteria:
- Born female, aged ≥40 years to ≤65 years at screening
- BMI ≥18 kg/m2 to ≤38 kg/m2
- Seeking treatment or relief for vasomotor symptoms associated with menopause and at screening having spontaneous amenorrhoea for ≥12 consecutive months; spontaneous amenorrhoea for ≥6 months with biochemical criteria of menopause (follicle-stimulating hormone >40 IU/L); or had bilateral oophorectomy ≥6 weeks before screening
- Within 10 days before randomisation, women should have a minimum average of 7 to 8 moderate to severe hot flushes (VMS) per day, or 50 to 60 per week
- Normal, negative, or no clinically significant findings on mammogram within the previous 12 months or at screening
- Normal or not clinically significant Papanicolaou test result within the previous 12 months, or at screening
- Willing to undergo a transvaginal ultrasound to evaluate the uterus and ovaries at screening and at Week 52 (end of treatment), and at early discontinuation for women who withdraw from the study before completion
- Willing to undergo an endometrial biopsy at screening and at Week 52 (end of treatment) unless they’ve had a supracervical or full hysterectomy; the endometrial biopsy obtained at screening should be considered evaluable, and they should be willing to undergo an endometrial biopsy in case of uterine bleeding or early discontinuation of the study or study drug
- Receiving strong or moderate CYP1A2 inhibitors, hormone replacement therapy, hormonal contraceptive, or any treatment for Vasomotor Symptoms (prescription, over the counter, or herbal)
- Previous or existing history of a malignant tumour, except for basal cell carcinoma
- Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg based on an average of 2 or 3 readings on at least two different occasions within the screening period; women who did not meet these criteria might, at the discretion of the investigator, be reassessed after initiation or review of antihypertensive measures; women with a medical history of hypertension could be enrolled at the discretion of the investigator once they were medically clear (stable and compliant)
- History within the past 6 months of undiagnosed uterine bleeding
- A medical condition or chronic disease (e.g., history of neurological [e.g., cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [e.g., moderate asthma], endocrine, or gynaecological disease) or malignancy that could confound interpretation of the study
- Active liver disease, jaundice, or elevated liver aminotransferases (alanine aminotransferase or aspartate aminotransferase), elevated total or direct bilirubin, elevated international normalised ratio, or elevated alkaline phosphatase
- Creatinine more than 1.5 times the upper limit of normal; or estimated glomerular filtration rate ≤59 mL/min/1.73 m² at screening
Abbreviations VMS, vasomotor symptoms. References 1. Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Granger AL, Fehnel SE, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Climacteric. 2008 Feb;11(1):32–43.
NOT CORRECT!
KNDy neurons become hyperactive due to loss of oestrogen inhibition, which overstimulates the thermoregulatory centre in the hypothalamus. This triggers VMS and provides a basis for developing targeted non-hormonal therapies.1-3
Learn more in the section: Mechanism of VMS.
They regulate vasodilation through spinal cord reflexes
Abbreviations ALT, alanine aminotransferase; AST, aspartate aminotransferase; LFT, liver function test; ULN, upper limit of normal. References 1. VEOZA SmPC §4.4 03.2025. 2. VEOZA SmPC §4.8 03.2025.
Abbreviations ALT, alanine aminotransferase; AST, aspartate aminotransferase; LFT, liver function test; ULN, upper limit of normal. References 1. VEOZA SmPC §4.4 03.2025. 2. VEOZA SmPC §4.8 03.2025.
NOT CORRECT!
VMS often persists longer than that, with a median persistence of 7.4 years.1 VMS varies widely among women, but prevalence generally peaks within the first two years after the final menstrual period.2
Learn more in the section: Menopause.
2.7 years
CORRECT!
By Week 12, 27.8% of women reported “much better” sleep vs 15.4% on placebo, as measured by the Patient Global Impression of Change in Sleep Disturbance (PGI-C SD).7
PGI-C SD was an exploratory endpoint.7
See more in next slides
27.8%
NOT CORRECT!
By Week 12, 27.8% of women reported “much better” sleep vs 15.4% on placebo, as measured by the Patient Global Impression of Change in Sleep Disturbance (PGI-C SD).7
PGI-C SD was an exploratory endpoint.7
See more in next slides
21.7%
Abbreviations BMI, body mass index; CYP1A2, cytochrome P450 1A2; PROMIS SD SF, Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
Abbreviations CI, confidence interval; LS, least squares; MMRM, mixed-model for repeated measures; PGI-C SD, Patient Global Impression of Change in Sleep Disturbance; PROMIS SD SF, Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form Questionnaire; VMS, vasomotor symptoms. References 1. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 2. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 3. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
Sleep disturbance3-6
6,13
Mood disturbance / depression3-5
Mood disturbance / depression3-5
VMS and mood
- VMS are linked to mood disturbances such as irritability, emotional distress, and embarrassment in both social and professional settings due to visible symptoms and odours.5
- VMS are associated with depressive symptoms in peri- and postmenopause, independent of oestrogen status.15
Mood disturbances from VMS can significantly reduce quality of life.4 Mood and sleep disturbances are bi-directionally related, creating a self-reinforcing cycle. Furthermore, depression has shown to increase risk of coronary heart disease by 1.5–2 times in healthy individuals6,13,15 — click on each to learn more.
13
CVD11,12
VMS
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.3,4 §LESS DISTURBED SLEEP: The pooled analysis from SKYLIGHT 1 and 2 showed a greater decrease in patient-reported sleep disturbances at Week 12 with VEOZA vs placebo (-4.8 and -3.3 from baseline, respectively; treatment difference: -1.5 [95% CI: -2.5, -0.5]).5 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; OTC, over-the-counter; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
Footnotes §MILDER EPISODES: The pooled result showed a reduction in VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 ¶STUDIED SAFETY PROFILE FOR VMS: The safety of VEOZA was evaluated in Phase 3 clinical studies with 2203 postmenopausal women and from spontaneous reporting in clinical practice.5 Abbreviations BMI, body mass index; CV, cardiovascular; KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SAE, serious adverse event; SD, standard deviation; SE, standard error; TEAE, treatment-emergent adverse event; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. VEOZA SmPC §4.8 03.2025.
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.4,5 §SIGNIFICANT EFFECT FROM WEEK 4: The pooled results from SKYLIGHT 1 and 2 demonstrated a clinically meaningful decrease from baseline at Week 4 compared to placebo (reduction of 2 or more VMS episodes per 24h; p<0.001). At Week 4, patients experienced a 52.84% reduction in the average daily frequency of hot flushes and night sweats in the VEOZA group [-5.79 (SE 0.23) from baseline 11.10 (SD 6.45)] compared to a 31.96% reduction in the placebo group [-3.51 (SE 0.22) from baseline 11.04 (SD 4.46)].2 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; VMS, vasomotor symptoms. References 1. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 5. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
Footnotes §MILDER EPISODES: The pooled result showed a reduction in VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 ¶STUDIED SAFETY PROFILE FOR VMS: The safety of VEOZA was evaluated in Phase 3 clinical studies with 2203 postmenopausal women and from spontaneous reporting in clinical practice.5 Abbreviations BMI, body mass index; CV, cardiovascular; KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SAE, serious adverse event; SD, standard deviation; SE, standard error; TEAE, treatment-emergent adverse event; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. VEOZA SmPC §4.8 03.2025.
Abbreviations ALT, alanine aminotransferase; AST, aspartate aminotransferase; LFT, liver function test; ULN, upper limit of normal. References 1. VEOZA SmPC §4.4 03.2025. 2. VEOZA SmPC §4.8 03.2025.
Weight & metabolism
Weight and metabolic changes1
Weight gain
Increased visceral adiposity
Study design1,*
Placebo
Visit:End of treatment
Randomisation 1:1:1 n=1,830
Visit:Follow-up
Screening
Fezolinetant 30 mg
Fezolinetant 45 mg
DAY 1
52 WEEKS
WEEK 52
WEEK 55
Figure adapted from reference 1. *The study design includes 30 mg arms to be consistent with SKYLIGHT 4. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to the 45 mg dose.
Abbreviations NKB, neurokinin B; NK3R, neurokinin 3 receptor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.1 03.2025. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Jayasena CN, Comninos AN, Stefanopoulou E, Buckley A, Narayanaswamy S, Izzi-Engbeaya C, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015 Feb 16;5:8466.
Footnotes ‡FEWER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction in VMS frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in the average daily frequency of hot flushes and night sweats at Week 12 was 63% in the VEOZA group [-6.94 (SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].1 §MILDER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; SSRI, selective serotonin reuptake inhibitor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102.
Abbreviations VMS, vasomotor symptoms. References 1. DePree B, Houghton K, Shiozawa A, Esterberg E, King DD, Kim J, et al. Treatment and resource utilization for menopausal symptoms in the United States: a retrospective review of real-world evidence from US electronic health records. Menopause. 2023 Jan 1;30(1):70–9. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Constantine GD, Graham S, Clerinx C, Bernick BA, Krassan M, Mirkin S, et al. Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries. Post Reprod Health. 2016 Sep;22(3):112–22.
Abbreviations VMS, vasomotor symptoms. References 1. Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr 1;175(4):531–9. 2. Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause. 2014 Sep 1;21(9):924–32.
CORRECT!
Blocking NKB-mediated activation of KNDy neurons restores normal KNDy activity, reducing overstimulation of thermoregulatory pathways, targeting the source of VMS to reduce their frequency and severity.1-3
Learn more in the section: Mechanism of VMS.
Because it restores normal KNDy neuron activity, reducing overstimulation of thermoregulatory pathways
Abbreviations HCPs, healthcare professionals; VMS, vasomotor symptoms. References 1. DePree B, Houghton K, Shiozawa A, Esterberg E, King DD, Kim J, et al. Treatment and resource utilization for menopausal symptoms in the United States: a retrospective review of real-world evidence from US electronic health records. Menopause. 2023 Jan 1;30(1):70–9. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Barber K, Charles A. Barriers to Accessing Effective Treatment and Support for Menopausal Symptoms: A Qualitative Study Capturing the Behaviours, Beliefs and Experiences of Key Stakeholders. Patient Prefer Adherence. 2023 Nov 15;17:2971–80. 4. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 5. Constantine GD, Graham S, Clerinx C, Bernick BA, Krassan M, Mirkin S, et al. Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries. Post Reprod Health. 2016 Sep;22(3):112–22. 6. Dintakurti N, Kalyanasundaram S, Jha P, Talaulikar V. An online survey and interview of GPs in the UK for assessing their satisfaction regarding the medical training curriculum and NICE guidelines for the management of menopause. Post Reprod Health. 2022 Sep;28(3):137–41.
Abbreviations NKB, neurokinin B; NK3, neurokinin 3; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Jayasena CN, Comninos AN, Stefanopoulou E, Buckley A, Narayanaswamy S, Izzi-Engbeaya C, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015 Feb 16;5:8466.
Inclusion and exclusion criteria1
Inclusion criteria:
Exclusion criteria:
- Born female, aged ≥40 years to ≤65 years at screening, with VMS due to menopause
- BMI ≥18 kg/m2 to ≤38 kg/m2
- Subject must be seeking treatment or relief for VMS associated with menopause and confirmed as postmenopausal per 1 of the following criteria at the screening visit
- Endometrial biopsy confirming the presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial malignancy, or other clinically significant findings at screening
- Use of strong or moderate cytochrome P450 1A2 inhibitors, hormone therapy, hormonal contraceptives, or any prescription, over-the-counter, or herbal treatment for Vasomotor Symptoms precluded participation, unless treatment was discontinued with drug-specific washout periods based on the known half-lives of the medications
- Spontaneous amenorrhea for ≥12 consecutive months
- Spontaneous amenorrhea for ≥6 months with biochemical criteria of menopause (follicle-stimulating hormone >40 IU/L), or having had bilateral oophorectomy ≥6 weeks prior to the screening visit, or
- Having had bilateral oophorectomy ≥6 weeks prior to the screening visit
NOT CORRECT!
VEOZA reduced VMS severity from moderate-severe to mild-moderate at Week 12.
VEOZA did not show a difference in VMS severity compared to placebo
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -0.67 [(SE 0.04) from baseline (2.40; SD 0.35)] vs -0.42 for the placebo group [(SE 0.04) from baseline (2.42; SD 0.34)].3
See more in next slides
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; NKB, neurokinin B; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94.
Footnotes ‡FEWER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction in VMS frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in the average daily frequency of hot flushes and night sweats at Week 12 was 63% in the VEOZA group [-6.94 (SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].1 §MILDER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; SSRI, selective serotonin reuptake inhibitor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102.
Study participants1-3
The studies consisted of postmenopausal women with a minimum average of 7 to 8 moderate to severe VMS per day or 50 to 60 per week within 10 days before randomisation:
- Mean age of ~54 years (≥40 and ≤65 years)*
- Self-identified as Caucasian (81%), Black (17%), Asian (1%), Hispanic/Latina ethnicity (24%)*
- Included menopausal women with prior hormone therapy use (19.9%), with oophorectomy (21.6%), or with hysterectomy (32.1%)*
*Baseline demographics also include women receiving fezolinetant 30 mg. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to the 45 mg dose.
CORRECT!
A study showed that 43–50% of women with menopausal symptoms do not seek any treatment, depending on the country, highlighting the large treatment gap in menopause care. Many women avoid seeking care due to discomfort discussing symptoms or embarrassment.1,2
Learn more in the section: Treatment options.
Around half of women
NOT CORRECT!
Blocking NKB-mediated activation of KNDy neurons restores normal KNDy activity, reducing overstimulation of thermoregulatory pathways, targeting the source of VMS to reduce their frequency and severity.1-3
Learn more in the section: Mechanism of VMS.
Because it promotes cooling by directly stimulating peripheral vasodilation
NOT CORRECT!
A study showed that 43–50% of women with menopausal symptoms do not seek any treatment, depending on the country, highlighting the large treatment gap in menopause care. Many women avoid seeking care due to discomfort discussing symptoms or embarrassment.1,2
Learn more in the section: Treatment options.
Around 1/4 of women
Abbreviations VMS, vasomotor symptyoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489–501.
NOT CORRECT!
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -6.94 [(SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].5
See more in next slides
VEOZA reduced the average daily frequency of hot flushes and night sweats by 63%.
~3 out of 5 episodes
Abbreviations NKB, neurokinin B; NK3, neurokinin 3; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Jayasena CN, Comninos AN, Stefanopoulou E, Buckley A, Narayanaswamy S, Izzi-Engbeaya C, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015 Feb 16;5:8466.
Abbreviations ALT, alanine aminotransferase; LFT, liver function test; ULN, upper limit of normal. References 1. VEOZA SmPC §4.4 03.2025. 2. VEOZA SmPC §4.8 03.2025.
Self-care5
- In one study, 81–100% of women with moderate to severe VMS reported a negative impact on their self-care.5
- VMS often lead to more frequent clothing changes, showers, and use of deodorant or perfume during the day.5
VMS
Self-care5
CORRECT!
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -6.94 [(SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].5
See more in next slides
VEOZA reduced the average daily frequency of hot flushes and night sweats by 63%.
~2 out of 3 episodes
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Rance NE, Dacks PA, Mittelman-Smith MA, Romanovsky AA, Krajewski-Hall SJ. Modulation of body temperature and LH secretion by hypothalamic KNDy (kisspeptin, neurokinin B and dynorphin) neurons: a novel hypothesis on the mechanism of hot flushes. Front Neuroendocrinol. 2013 Aug;34(3):211–27. 3. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132.
Footnotes ‡FEWER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction in VMS frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in the average daily frequency of hot flushes and night sweats at Week 12 was 63% in the VEOZA group [-6.94 (SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].1 §MILDER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; SSRI, selective serotonin reuptake inhibitor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102.
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.3,4 §LESS DISTURBED SLEEP: The pooled analysis from SKYLIGHT 1 and 2 showed a greater decrease in patient-reported sleep disturbances at Week 12 with VEOZA vs placebo (-4.8 and -3.3 from baseline, respectively; treatment difference: -1.5 [95% CI: -2.5, -0.5]).5 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; OTC, over-the-counter; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
NOT CORRECT!
Blocking NKB-mediated activation of KNDy neurons restores normal KNDy activity, reducing overstimulation of thermoregulatory pathways, targeting the source of VMS to reduce their frequency and severity.1-3
Learn more in the section: Mechanism of VMS.
Because it stimulates oestrogen production through the hypothalamic-pituitary feedback loop
CORRECT!
Up to 80% of women experience VMS during the menopausal transition.1,2
Learn more in the section: Life with VMS.
Up to 8 in 10 women experience VMS
Abbreviations ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal; VMS, vasomotor symptoms. References 1. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 2. VEOZA SmPC §5.1 03.2025. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999. 6. VEOZA SmPC §4.2 03.2025. 7. VEOZA SmPC §4.8 03.2025. 8. VEOZA SmPC §4.4 03.2025.
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms.
Abbreviations SE, standard error; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
Abbreviations SD, standard deviation; SE, standard error; VMS, vasomotor symptoms. References 1. Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr 1;175(4):531–9. 2. Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause. 2014 Sep 1;21(9):924–32. 3. Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Granger AL, Fehnel SE, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Climacteric. 2008 Feb;11(1):32–43. 4. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 5. VEOZA SmPC §5.1 03.2025.
Abbreviations CYP1A2, cytochrome P540 1A2; eGFR, estimated Glomerular Filtration Rate. References 1. VEOZA SmPC §4.3 03.2025. 2. VEOZA SmPC §4.5 03.2025. 3. VEOZA SmPC §4.6 03.2025. 4. VEOZA SmPC §4.2 03.2025.
Abbreviations ALP, alkaline phosphatase; COVID-19, coronavirus disease 2019; CPK, creatine phosphokinase; TEAE, treatment emergent adverse event. References 1. VEOZA SmPC §4.8 03.2025. 2. Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147–64.
Abbreviations NKB, neurokinin B; NK3R, neurokinin 3 receptor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.1 03.2025. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Jayasena CN, Comninos AN, Stefanopoulou E, Buckley A, Narayanaswamy S, Izzi-Engbeaya C, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015 Feb 16;5:8466.
Abbreviations VMS, vasomotor symptyoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489–501.
Sleep disturbance3-6
4,6
Reduced work productivity3,5,7
Reduced work productivity3,5,7
- VMS can reduce work productivity through interruptions and coping behaviours, such as cooling off, changing clothes, showering, and applying deodorant or perfume.5
- A 2025 Nordic study showed that moderate to severe VMS reduced work productivity by 24.2%.3
- A study found that women with untreated VMS had 57% more indirect work productivity loss days than controls.7
Job strain and high work demands are linked to more sleep disturbances. In turn, poor sleep quality can reduce work productivity and overall quality of life.6 Furthermore, women with inadequate sleep related to VMS report being slower, struggling with tasks, and feeling tired during the day, which may also affect work productivity5 — click on each to learn more.
VMS
Abbreviations QoL, quality of life; VMS, vasomotor symptoms. References 1. Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199–215. 2. Williams RE, Levine KB, Kalilani L, Lewis J, Clark RV. Menopause-specific questionnaire assessment in US population-based study shows negative impact on health-related quality of life. Maturitas. 2009 Feb 20;62(2):153–9. 3. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 4. Kronenberg F. Menopausal hot flashes: a review of physiology and biosociocultural perspective on methods of assessment. J Nutr. 2010 Jul;140(7):1380S–5S. 5. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132.
NOT CORRECT!
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -6.94 [(SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].5
See more in next slides
VEOZA reduced the average daily frequency of hot flushes and night sweats by 63%.
~2 out of 7 episodes
Abbreviations VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.2 03.2025. 2. VEOZA SmPC §3 03.2025. 3. VEOZA SmPC §4.1 03.2025.
NOT CORRECT!
Blocking NKB-mediated activation of KNDy neurons restores normal KNDy activity, reducing overstimulation of thermoregulatory pathways, targeting the source of VMS to reduce their frequency and severity.1-3
Learn more in the section: Mechanism of VMS.
Because it enhances serotonin activity, stabilising temperature regulation
Abbreviations LS, least squares; SE, standard error; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 4. VEOZA SmPC §4.1 03.2025.
Vasomotor symptoms
Vasomotor symptoms (VMS)5
VMS are commonly known as hot flushes and night sweats:
Hot flushes: Episodes of sudden intense sensation of heat, lasting 1 to 5 minutes, and typically starting in the face, neck, or chest and spreading across the torso, with frequency ranging from a few per week to multiple times per day.
Night sweats: Hot flushes that occur at night, normally during sleep.
NOT CORRECT!
VMS are very common, affecting up to
80% of women during the menopausal transition.1,2
Learn more in the section: Life with VMS.
Every woman experiences VMS
Abbreviations BMI, body mass index; CYP1A2, cytochrome P450 1A2; PROMIS SD SF, Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
NOT CORRECT!
VEOZA reduced VMS severity from moderate-severe to mild-moderate at Week 12.
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -0.67 [(SE 0.04) from baseline (2.40; SD 0.35)] vs -0.42 for the placebo group [(SE 0.04) from baseline (2.42; SD 0.34)].3
VEOZA shifted VMS severity from moderate-severe to moderate
See more in next slides
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.3,4 §LESS DISTURBED SLEEP: The pooled analysis from SKYLIGHT 1 and 2 showed a greater decrease in patient-reported sleep disturbances at Week 12 with VEOZA vs placebo (-4.8 and -3.3 from baseline, respectively; treatment difference: -1.5 [95% CI: -2.5, -0.5]).5 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; OTC, over-the-counter; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.4,5 §SIGNIFICANT EFFECT FROM WEEK 4: The pooled results from SKYLIGHT 1 and 2 demonstrated a clinically meaningful decrease from baseline at Week 4 compared to placebo (reduction of 2 or more VMS episodes per 24h; p<0.001). At Week 4, patients experienced a 52.84% reduction in the average daily frequency of hot flushes and night sweats in the VEOZA group [-5.79 (SE 0.23) from baseline 11.10 (SD 6.45)] compared to a 31.96% reduction in the placebo group [-3.51 (SE 0.22) from baseline 11.04 (SD 4.46)].2 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; VMS, vasomotor symptoms. References 1. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 5. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
Sexual function1
Decreased sexual desire
Dyspareunia (painful intercourse)
Sexual function
WEEK 12
Switched to VEOZA 45 mg
Placebo participants switched to VEOZA
AT WEEK 12
Following the 12-week placebo-controlled treatment period, patients were enrolled in an extension period. Those initially taking a placebo were switched to VEOZA, while patients who were initiated on VEOZA continued their treatment.1,2 Mean change in moderate to severe VMS data frequency was collected each week for an additional 40 weeks. The data during the extension period were summarised descriptively, with no inferential testing, due to the absence of a placebo control.1,2
Footnotes ‡FEWER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction in VMS frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in the average daily frequency of hot flushes and night sweats at Week 12 was 63% in the VEOZA group [-6.94 (SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].1 §MILDER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; SSRI, selective serotonin reuptake inhibitor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102.
Study design2,3,*
Fezolinetant 30 mg
Placebo
Fezolinetant 45 mg
Visit:End of treatment
Randomisation 1:1:1 n=1,022
Visit:Follow-up
Screening
Fezolinetant 30 mg
Fezolinetant 30 mg
Fezolinetant 45 mg
Fezolinetant 45 mg
DAY 1
WEEK 4
WEEK 12
40-WEEK EXTENSION
WEEK 52
WEEK 55
Figure adapted from references 2 and 3. *The study design includes 30 mg arms to be consistent with SKYLIGHT 1 and SKYLIGHT 2. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to the 45 mg dose.
Abbreviations QoL, quality of life; VMS, vasomotor symptoms. References 1. Zhu D, Chung HF, Dobson AJ, Pandeya N, Giles GG, Bruinsma F, et al. Age at natural menopause and risk of incident cardiovascular disease: a pooled analysis of individual patient data. Lancet Public Health. 2019 Nov 1;4(11):e553–64. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Malmberg C, Althin R, Olofsson S. Productivity loss related to vasomotor symptoms (VMS) during menopausal transition among women in the Nordics. IHE-The Swedish Institute for Health Economics; 2024. 4. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 5. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 6. POPU01: Population 1 January by unit, reporting country, age, sex and time [Internet]. [Cited 2025 Jul 18]. Available from: https://pxweb.nordicstatistics.org/pxweb/en/Nordic%20Statistics/Nordic%20Statistics__Demography__Population%20size/POPU01.px/?rxid=4bd7ba15-3c4a-4793-8711-6db1fc878223
Abbreviations CI, confidence interval; LS, least squares; MMRM, mixed-model for repeated measures; PGI-C SD, Patient Global Impression of Change in Sleep Disturbance; PROMIS SD SF, Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form Questionnaire; VMS, vasomotor symptoms. References 1. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 2. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 3. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
POSTMENOPAUSE
Postmenopause is the lifelong stage following the final menstrual period.2 This stage is defined by:
- Onset after the final menstrual period, diagnosed retrospectively after 12 months of amenorrhoea1,2
- Sustained low oestrogen levels and variable symptom patterns1
Figure adapted from reference 4.
postmenopause
51 yr on average Final menstrual period
Study participants1-3
The studies consisted of postmenopausal women with a minimum average of 7 to 8 moderate to severe VMS per day or 50 to 60 per week within 10 days before randomisation:
- Mean age of ~54 years (≥40 and ≤65 years)*
- Self-identified as Caucasian (81%), Black (17%), Asian (1%), Hispanic/Latina ethnicity (24%)*
- Included menopausal women with prior hormone therapy use (19.9%), with oophorectomy (21.6%), or with hysterectomy (32.1%)*
*Baseline demographics also include women receiving fezolinetant 30 mg. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to the 45 mg dose.
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. VEOZA SmPC §4.1 03.2025.
Abbreviations CNS, central nervous system; CVD, cardiovascular disease; VMS, vasomotor symptoms. References 1. Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489–501. 2. Williams RE, Levine KB, Kalilani L, Lewis J, Clark RV. Menopause-specific questionnaire assessment in US population-based study shows negative impact on health-related quality of life. Maturitas. 2009 Feb 20;62(2):153–9. 3. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 4. Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005 Aug 5;3:47. 5. English M, Stoykova B, Slota C, Doward L, Siddiqui E, Crawford R, et al. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS sleep disturbance and sleep-related impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes. 2021 Apr 26;5(1):37. 6. Baker FC, Lampio L, Saaresranta T, Polo-Kantola P. Sleep and sleep disorders in the menopausal transition. Sleep Med Clin. 2018 Sep;13(3):443–56. 7. Sarrel P, Portman D, Lefebvre P, Lafeuille MH, Grittner AM, Fortier J, et al. Incremental direct and indirect costs of untreated vasomotor symptoms. Menopause. 2015 Mar;22(3):260–6. 8. Thurston RC, Carroll JE, Levine M, Chang Y, Crandall C, Manson JE, et al. Vasomotor Symptoms and Accelerated Epigenetic Aging in the Women's Health Initiative (WHI). J Clin Endocrinol Metab. 2020 Apr 1;105(4):1221–7. 9. Thurston RC, Maki PM, Derby CA, Sejdić E, Aizenstein HJ. Menopausal hot flashes and the default mode network. Fertil Steril. 2015 Jun;103(6):1572–8.e1. 10. Thurston RC, Aizenstein HJ, Derby CA, Sejdić E, Maki PM. Menopausal hot flashes and white matter hyperintensities. Menopause. 2016 Jan;23(1):27–32. 11. Thurston RC. Vasomotor symptoms: natural history, physiology, and links with cardiovascular health. Climacteric. 2018 Apr;21(2):96–100. 12. Thurston RC, Chang Y, Barinas-Mitchell E, Jennings JR, Landsittel DP, Santoro N, et al. Menopausal Hot Flashes and Carotid Intima Media Thickness Among Midlife Women. Stroke. 2016 Dec;47(12):2910–5. 13. Lett HS, Blumenthal JA, Babyak MA, Sherwood A, Strauman T, Robins C, et al. Depression as a risk factor for coronary artery disease: evidence, mechanisms, and treatment. Psychosom Med. 2004 May–Jun;66(3):305–15. 14. Cappuccio FP, Cooper D, D'Elia L, Strazzullo P, Miller MA. Sleep duration predicts cardiovascular outcomes: a systematic review and meta-analysis of prospective studies. Eur Heart J. 2011 Jun 1;32(12):1484–92. 15. Avis NE, Crawford S, Stellato R, Longcope C. Longitudinal study of hormone levels and depression among women transitioning through menopause. Climacteric. 2001 Jan 1;4(3):243–9.
Abbreviations HCPs, healthcare professionals; VMS, vasomotor symptoms. References 1. DePree B, Houghton K, Shiozawa A, Esterberg E, King DD, Kim J, et al. Treatment and resource utilization for menopausal symptoms in the United States: a retrospective review of real-world evidence from US electronic health records. Menopause. 2023 Jan 1;30(1):70–9. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Barber K, Charles A. Barriers to Accessing Effective Treatment and Support for Menopausal Symptoms: A Qualitative Study Capturing the Behaviours, Beliefs and Experiences of Key Stakeholders. Patient Prefer Adherence. 2023 Nov 15;17:2971–80. 4. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 5. Constantine GD, Graham S, Clerinx C, Bernick BA, Krassan M, Mirkin S, et al. Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries. Post Reprod Health. 2016 Sep;22(3):112–22. 6. Dintakurti N, Kalyanasundaram S, Jha P, Talaulikar V. An online survey and interview of GPs in the UK for assessing their satisfaction regarding the medical training curriculum and NICE guidelines for the management of menopause. Post Reprod Health. 2022 Sep;28(3):137–41.
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.3,4 §LESS DISTURBED SLEEP: The pooled analysis from SKYLIGHT 1 and 2 showed a greater decrease in patient-reported sleep disturbances at Week 12 with VEOZA vs placebo (-4.8 and -3.3 from baseline, respectively; treatment difference: -1.5 [95% CI: -2.5, -0.5]).5 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; OTC, over-the-counter; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
Abbreviations ALP, alkaline phosphatase; COVID-19, coronavirus disease 2019; CPK, creatine phosphokinase; TEAE, treatment emergent adverse event. References 1. VEOZA SmPC §4.8 03.2025. 2. Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147–64.
Abbreviations ALT, alanine aminotransferase; AST, aspartate aminotransferase; MedRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event; SOC, system organ class. References 1. VEOZA SmPC §4.8 03.2025.
Urogenital system1
Vaginal dryness
Vulvar itching and burning
Dysuria (painful urination)
Urinary frequency and urgency
Recurrent lower urinary tract infections
Urogenital system
Participants in the study:1
- Self-identified as Caucasian (80%), Black (17%), Asian (2%), Hispanic/Latina ethnicity (20%)*
- Included menopausal women with prior hormone therapy use (17.0%), with oophorectomy (13.5%), or with hysterectomy (18.6%)*
*Baseline demographics also include women receiving fezolinetant 30 mg. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to the 45 mg dose
Skin, mucosa, & hair
Skin, mucosa, & hair1
Reduced skin thickness
Reduced elasticity
Reduced skin hydration
Increased wrinkling
Hair loss
Norway - Is she getting right support for VMS?
Astellas Nordic
Created on October 21, 2025
Start designing with a free template
Discover more than 1500 professional designs like these:
View
Vision Board
View
Periodic Table
View
SWOT Challenge: Classify Key Factors
View
Explainer Video: Keys to Effective Communication
View
Explainer Video: AI for Companies
View
Corporate CV
View
Flow Presentation
Explore all templates
Transcript
the
Is she getting right support for her menopause symptoms?
Explore the most common clinical questions around menopause and vasomotor symptoms – and gain applicable knowledge you can use in practice today.
MAT-NO-VEO-2025-00048 | Date of preparation 21.10.2025
to
Explore approaches support women with vasomotor symptoms (VMS)
What’s happening to my patients?
Is VEOZA right for her?
What can patients expect from VEOZA?
What to consider when prescribing VEOZA?
Learn about menopause and VMS, why symptoms occur, and their impact on women and society. Understand the challenges women face when VMS go untreated.
Discover how VEOZA works and which patients are suitable for this therapy. Explore different patient profiles and understand who may benefit from this treatment.
Explore the clinical data supporting VEOZA’s efficacy and safety profile in treating VMS. Learn how this therapy provides clinically meaningful relief for patients.
Learn about the prescribing considerations for VEOZA therapy. Access dosing protocols, contraindications, and safety considerations before starting therapy.
What’s happening to my patients?
Is VEOZA right for her?
What can patients expect from VEOZA?
What to consider when prescribing VEOZA?
How much do you know about menopause & VMS?
QUIZ
Back
What to expect when menopause symptoms appear?
MENOPAUSE
What is the extent of the VMS burden for women and society?
LIFE WITH VMS
What's happening my patients?
to
What's happening in the body when VMS occur?
MECHANISM OF VMS
Menopause is associated with a wide range of symptoms – some clearly linked to hormonal changes, others less immediately recognised. VMS, also known as hot flushes and night sweats, are common and often underreported.1,2 Learn how these symptoms can impact your patients.
What are the current VMS treatments and barriers to care?
TREATMENT OPTIONS
MAT-NO-VEO-2025-00048 | Date of preparation 21.10.2025
Abbreviations & references
How much do you know about menopause & VMS?
QUIZ
Back
What to expect when menopause symptoms appear?
MENOPAUSE
What's happening my patients?
to
What is the extent of the VMS burden for women and society?
LIFE WITH VMS
Menopause is associated with a wide range of symptoms – some clearly linked to hormonal changes, others less immediately recognised. VMS, also known as hot flushes and night sweats, are common and often underreported.1,2 Learn how these symptoms can impact your patients.
What's happening in the body when VMS occur?
MECHANISM OF VMS
more
Do you want information?
Get the latest updates and events related to VMS and VEOZA
What are the current VMS treatments and barriers to care?
TREATMENT OPTIONS
MAT-NO-VEO-2025-00048 | Date of preparation 21.10.2025
Abbreviations & references
MENOPAUSE
Back
when
What TO expect menopause symptoms appear?
Menopause is a natural biological process marking the permanent cessation of menstruation for at least 12 consecutive months, resulting from the loss of ovarian follicular activity.1,2
Menopause transition:
menopause
Premenopause
postmenopause
perimenopause
51 yr on average Final menstrual period
35-45 yr Last regular menstrual cycle
11-15 yr Menarche
12 months with amenorrhoea
Figure adapted from references 3 and 4.
References
MENOPAUSE
Back
What TO expect menopause symptoms appear?
when
The symptoms of menopause can be very distressing and can considerably affect the personal, social, and work lives of women.1
Click to
EXPLORE
Vasomotor symptoms
Vasomotor symptoms (VMS):
Central nervous system
Skin, mucosa, & hair
Occurring often multiple times a day, VMS are reported as the most burdensome symptoms of menopause.1,2
VMS affect up to
80%
of women1,3
Muscoskeletal system
Substantially impact women’s QoL by severely affecting:1,2
Weight & metabolism
Energy levels
Concentration
Sleep
Mood
Sexual function
Despite VMS being one of the main reasons for seeking menopause treatment,3,4 VMS remain undertreated.3
Urogenital system
Figure adapted from reference 1.
Abbreviations & references
MENOPAUSE
Back
What TO expect menopause symptoms appear?
when
Different trajectories of VMS scores (based on self-reported frequency of hot flushes and night sweat):2
Severity types of VMS:1
Flip the cards to learn more about VMS severity.
MILD
MODERATE
SEVERE
A sensation of heat with sweating. Ability to continue with activities.
A sensation of heat with sweating. Causes cessation of activities.
A sensation of heat without sweating.
SEVERE
MODERATE
MILD
Figure adapted from reference 2.
Duration of symptoms: median of 7.4 years3
Women follow different VMS patterns, underlining the individual nature of menopause2
Abbreviations & references
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
VMS last for a median of 7.4 years and generally peak within the first two years after the final menstrual period.1,2
EFFECT ON WOMEN'S QoL
Night sweats frequency
Prevalence
Hot flushes frequency
80%
VMS can have a negative impact on women’s QoL.
The frequency of night sweats varies greatly, from only a few times a month to several times a night.3
The frequency of hot flushes varies greatly, from only a few times a month to several times a day.3
Up to
VMS are frequently associated with:4-5
Do you know how many hot flushes women experience daily?
Do you know how many night sweats women experience daily?
Do you know how many women experience VMS during the menopausal transition?
Do you know how VMS can affect women’s quality of life?
Sleep disruption
Peri- and postmenopausal women can experience multiple VMS episodes per night – with most reporting 1–2 nightly episodes.3
Peri- and postmenopausal women can experience multiple VMS episodes per day – with some reporting 7 or more hot flushes daily.3
Reduced focus
will experience VMS during the menopausal transition.1-4
Impaired productivity
Abbreviations & references
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
VMS trigger a “domino effect” of symptoms
Beyond the primary heat sensation and sweating, VMS can trigger a cascade of secondary symptoms such as sleep disturbances, cognitive difficulties, and mood changes, that intensify with VMS frequency.1-3
Click on the icons to
EXPLORE
VMS
Figure made by Astellas from references 3–14.
Abbreviations & references
1.7
million
menopausal women
In the Nordic region, nearly 1.7 million women are aged 45–54 years, the typical range for menopause onset.6
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
How VMS can impact women in the 21st century:
1/3
Increased life expectancy means that many women will spend up to a third of their lives postmenopausal.1
This life phase may be even longer for women experiencing early menopause.1
Increased life expectancy
Impact on work and private life
Treatment gaps
Abbreviations & references
1.7
million
menopausal women
In the Nordic region, nearly 1.7 million women are aged 45–54 years, the typical range for menopause onset.6
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
How VMS can impact women in the 21st century:
Increased life expectancy
Multiple studies demonstrate that VMS significantly impair QoL and productivity at:2,3
Home
Impact on work and private life
Work
Treatment gaps
Abbreviations & references
1.7
million
menopausal women
In the Nordic region, nearly 1.7 million women are aged 45–54 years, the typical range for menopause onset.6
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
How VMS can impact women in the 21st century:
Increased life expectancy
VMS are the primary reason why women seek menopause care.2
However, VMS remain widely untreated.4
Impact on work and private life
of symptomatic women do not take treatment for their VMS5
>60%
not receiving therapy even after clinical consultation2
40%
Treatment gaps
Abbreviations & references
1.7
million
menopausal women
In the Nordic region, nearly 1.7 million women are aged 45–54 years, the typical range for menopause onset.6
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
How VMS can impact women in the 21st century:
1/3
Increased life expectancy means that many women will spend up to a third of their lives postmenopausal.1
This life phase may be even longer for women experiencing early menopause.1
Increased life expectancy
Impact on work and private life
Treatment gaps
Abbreviations & references
LIFE WITH VMS
Back
for
What is the extent of the VMS burden women and society?
VMS in working women in the Nordics
Presenteeism and absenteeism
Nordic women represent nearly half the workforce and are among the most economically active worldwide.1,2
Moderate to severe VMS significantly reduce work productivity through both presenteeism and absenteeism, especially during women’s most professionally active years.6
Reduced productivity while at work.6
Presenteeism:
Absence from work.6
Absenteeism:
Women comprise the majority in healthcare, public services, and service sectors.3–5
Across the Nordic countries, the estimated annual costs due to VMS are
~€865 million.6
How do VMS affect women in my country?
Click to expand the graph
Understanding menopause's impact on workforce participation is crucial, with growing economic implications as more women work through and beyond menopause.1,6
Abbreviations & references
MECHANISM OF VMS
Back
when
What's happening in the body VMS occur?
During menopause, dropping oestrogen levels disrupt the brain's temperature control. This leads to an overactivity of the thermoregulatory centre, causing hot flushes and night sweats.1,2
Narrowing of the interthreshold zone throughout menopause3
With menopause, the natural depletion of ovarian follicles leads to a drop in circulating oestrogen.1,2 At this point, the regulatory control of KNDy neurons is lost.3
PERIMENOPAUSE
Oestrogen secreted by the ovaries regulates KNDy neurons in the hypothalamus,1 which help maintain the core temperature of the body within the sweating and shivering thresholds.3
PREMENOPAUSE
At low oestrogen levels, the thermoneutral zone is narrowed. This causes exaggerated physiological responses that are experienced as hot flushes and night sweats.3
MENOPAUSE
PERIMENOPAUSE
PREMENOPAUSE
MENOPAUSE
Sweating threshold
Hot flushes
Core body temperature
Body temperature fluctuation
Shiveringthreshold
Figure adapted from reference 3.
Abbreviations & references
MECHANISM OF VMS
Back
when
What's happening in the body VMS occur?
Inside a hot flush: from brain to symptom
KNDy neurons, located in the hypothalamus, are typically balanced by oestrogen and NKB and become hyperactive as oestrogen declines during menopause. This imbalance leads to increased NKB signalling, dysregulating the thermoregulatory centre and consequently leading to VMS.1,2
peri- and postmenopause3
Premenopause3
Switch between premenopause and peri- and postmenopause and click to explore
NK3R
NK3R
NKB binds to neurokinin 3 receptors (NK3R).
Normal cooling
KNDY neuron
Physiological response
Regulated NKB signalling results in normal cooling of the body.
KNDy neuron
KNDy neurons innervate the thermoregulatory centre and are stimulated by NKB via NK3R and are inhibited by oestrogen.
Thermoregulatory centre
Changes in temperature trigger heat dissipation mechanisms, like sweating and peripheral vasodilatation.
NKB
NKB
NKB stimulates KNDy neurons.
Thermo- regulatory centre
NKB signalling
Balanced KNDy activity, maintained by oestrogen’s inhibition of KNDy neurons, keeps the thermoregulatory centre stable.
Oestrogen
Oestrogen
Circulating oestrogen inhibits KNDy neurons.
NKB signalling
Figure adapted from reference 3.
Abbreviations & references
MECHANISM OF VMS
Back
when
What's happening in the body VMS occur?
Inside a hot flush: from brain to symptom
KNDy neurons, located in the hypothalamus, are typically balanced by oestrogen and NKB and become hyperactive as oestrogen declines during menopause. This imbalance leads to increased NKB signalling, dysregulating the thermoregulatory centre and consequently leading to VMS.1,2
Premenopause3
peri- and postmenopause3
NK3R
NK3R
Increased NKB binds to neurokinin 3 receptors (NK3R).
KNDy neuron
KNDy neurons become hypertrophied, contributing to increased signalling to the thermoregulatory centre.
Hot flushes
Hot flushes
Increased activation of heat dissipation mechanisms results in hot flushes and night sweats.
KNDY neuron
Altered thermoregulatory centre
Altered signalling in the thermoregulatory centre shifts the balance for control of core body temperature and activates heat dissipation effectors.
NKB
NKB
NKB stimulates KNDy neurons further, as oestrogen declines.
Increased NKB signalling
Loss of oestrogen inhibition causes KNDy overactivity, increasing NKB signals to the thermoregulatory centre.
Thermo- regulatory centre
Oestrogen
Oestrogen
Declining oestrogen levels leave NKB signalling unopposed.
NKB signalling
Figure adapted from reference 3.
Abbreviations & references
MECHANISM OF VMS
Back
when
What's happening in the body VMS occur?
Inside a hot flush: from brain to symptom
KNDy neurons, located in the hypothalamus, are typically balanced by oestrogen and NKB and become hyperactive as oestrogen declines during menopause. This imbalance leads to increased NKB signalling, dysregulating the thermoregulatory centre and consequently leading to VMS.1,2
peri- and postmenopause3
Premenopause3
NK3R
NK3R
NKB binds to neurokinin 3 receptors (NK3R).
KNDy neuron
KNDy neurons innervate the thermoregulatory centre and are stimulated by NKB via NK3R and are inhibited by oestrogen.
Normal cooling
KNDY neuron
Physiological response
Regulated NKB signalling results in normal cooling of the body.
Thermoregulatory centre
Changes in temperature trigger heat dissipation mechanisms, like sweating and peripheral vasodilatation.
NKB
NKB
NKB stimulates KNDy neurons.
NKB signalling
Balanced KNDy activity, maintained by oestrogen’s inhibition of KNDy neurons, keeps the thermoregulatory centre stable.
Thermo- regulatory centre
Oestrogen
Oestrogen
Circulating oestrogen inhibits KNDy neurons.
NKB signalling
Figure adapted from reference 3.
Abbreviations & references
MECHANISM OF VMS
Back
when
What's happening in the body VMS occur?
During menopause, dropping oestrogen levels disrupt the brain's temperature control. This leads to an overactivity of the thermoregulatory centre, causing hot flushes and night sweats.1,2
Narrowing of the interthreshold zone throughout menopause3
At low oestrogen levels, the thermoneutral zone is narrowed. This causes exaggerated physiological responses that are experienced as hot flushes and night sweats.3
MENOPAUSE
Oestrogen secreted by the ovaries regulates KNDy neurons in the hypothalamus,1 which help maintain the core temperature of the body within the sweating and shivering thresholds.3
PREMENOPAUSE
With menopause, the natural depletion of ovarian follicles leads to a drop in circulating oestrogen.1,2 At this point, the regulatory control of KNDy neurons is lost.3
PERIMENOPAUSE
Sweating threshold
Hot flushes
Core body temperature
Body temperature fluctuation
Shiveringthreshold
Figure adapted from reference 3.
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Despite available treatments, many women with moderate to severe VMS remain untreated, highlighting an unmet need.1-3
Can you identify the hidden barriers for menopause care? Click on the dialogues to explore.
BARRIERS
TREATMENT GAPS
Lack of information about available prescription treatment options may deter women from seeking treatment until symptoms become severe, and insufficient knowledge among HCPs about the full range of menopause therapies can further limit access to appropriate care.3,5
Menopause is often viewed as a natural and inevitable part of aging, and because it affects all women, many believe it doesn’t require any treatment.2-4
"You’ll be fine, menopause is natural"
"I don’t know the treatment options"
Many patients feel discomfort discussing intimate symptoms and may experience stigma around menopause and limited awareness of treatment options.3-5
Classic menopause symptoms can be easily diagnosed. However, subtle or isolated symptoms are often dismissed or misattributed to other conditions, with menopause frequently overlooked.3
"I don’t get the help I need from my doctor"
"I don’t like talking about it"
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Despite available treatments, many women with moderate to severe VMS remain untreated, highlighting an unmet need.1-3
Treatment gaps often go unnoticed until they widen. Explore the underlying gaps in VMS care.
TREATMENT GAPS
BARRIERS
43–50%
5,*
How many postmenopausal women experiencing VMS do not seek medical help?
Less than
50%
6,†
What percentage of GPs feel comfortable managing and treating patients with menopause-related health problems?
46%
4,‡
Among Nordic women, how many have never received any treatment for VMS, regardless of seeking advice?
*Based on an online survey conducted across five European countries (France, Germany, Italy, Spain, and the United Kingdom; N=2610).5 †Based on an online survey and interview conducted with GPs in the United Kingdom (N=173).6 ‡Based on an online survey conducted with women aged 40–65 years in the Nordics (Denmark, Finland, Norway, and Sweden; N=863).4
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Despite available treatments, many women with moderate to severe VMS remain untreated, highlighting an unmet need.1-3
Can you identify the hidden barriers for menopause care? Click on the dialogues to explore.
BARRIERS
TREATMENT GAPS
Lack of information about available prescription treatment options may deter women from seeking treatment until symptoms become severe, and insufficient knowledge among HCPs about the full range of menopause therapies can further limit access to appropriate care.3,5
Menopause is often viewed as a natural and inevitable part of aging, and because it affects all women, many believe it doesn’t require any treatment.2-4
"You’ll be fine, menopause is natural"
"I don’t know the treatment options"
Many patients feel discomfort discussing intimate symptoms and may experience stigma around menopause and limited awareness of treatment options.3-5
Classic menopause symptoms can be easily diagnosed. However, subtle or isolated symptoms are often dismissed or misattributed to other conditions, with menopause frequently overlooked.3
"I don’t get the help I need from my doctor"
"I don’t like talking about it"
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Treatment options for VMS have evolved significantly, offering women multiple therapeutic approaches that differ in their mechanisms of action, effectiveness, safety, and patient suitability.1-3
MENOPAUSAL HORMONE THERAPY (MHT)
NON-hormonal therapies
Self-help strategies
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Treatment options for VMS have evolved significantly, offering women multiple therapeutic approaches that differ in their mechanisms of action, effectiveness, safety, and patient suitability.1-3
MENOPAUSAL HORMONE THERAPY (MHT)
NON-hormonal therapies
Self-help strategies
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Treatment options for VMS have evolved significantly, offering women multiple therapeutic approaches that differ in their mechanisms of action, effectiveness, safety, and patient suitability.1-3
NON-hormonal therapies
MENOPAUSAL HORMONE THERAPY (MHT)
Self-help strategies
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Treatment options for VMS have evolved significantly, offering women multiple therapeutic approaches that differ in their mechanisms of action, effectiveness, safety, and patient suitability.1-3
self-help strategies
MENOPAUSAL HORMONE THERAPY (MHT)
NON-hormonal therapies
Abbreviations & references
TREATMENT OPTIONS
Back
and
What are the current VMS treatments barriers to care?
Treatment options for VMS have evolved significantly, offering women multiple therapeutic approaches that differ in their mechanisms of action, effectiveness, safety, and patient suitability.1-3
MENOPAUSAL HORMONE THERAPY (MHT)
NON-hormonal therapies
Self-help strategies
Abbreviations & references
Back
and
QUICK CHECK: MENOPAUSE VMS
VMS affects millions of women, yet many cases go untreated. As VMS is the most common and often reported as the most bothersome symptom during the menopausal transition, understanding its mechanisms, duration, and the latest evidence is key to better supporting patients.1-3 Test your knowledge with this quick quiz.
Abbreviations & references
QUIZ
Back
Quick check: Menopause & VMS
of
QUESTION 1 5
Do you know the median duration of VMS?
2.7 years
4.8 years
5.6 years
7.4 years
Abbreviations & references
QUIZ
Back
Quick check: Menopause & VMS
of
QUESTION 2 5
How common are VMS among women in the menopausal transition?
Up to 2 in 10 women experience VMS
Up to 5 in 10 women experience VMS
Up to 8 in 10 women experience VMS
Every woman experiences VMS
Abbreviations & references
QUIZ
Back
Quick check: Menopause & VMS
of
QUESTION 3 5
Do you know the role of KNDy neurons in VMS pathophysiology?
They respond to temperature changes by regulating norepinephrine release
They become hyperactive due to loss of oestrogen inhibition, disrupting thermoregulation
They regulate vasodilation through spinal cord reflexes
They stimulate sweat glands directly through autonomic pathways
Abbreviations & references
QUIZ
Back
Quick check: Menopause & VMS
of
QUESTION 4 5
Why is blocking neurokinin B (NKB)-mediated activation of KNDy neurons effective in the treatment of VMS?
Because it restores normal KNDy neuron activity, reducing overstimulation of thermoregulatory pathways
Because it stimulates oestrogen production through the hypothalamic-pituitary feedback loop
Because it enhances serotonin activity, stabilising temperature regulation
Because it promotes cooling by directly stimulating peripheral vasodilation
Abbreviations & references
QUIZ
Back
Quick check: Menopause & VMS
of
QUESTION 5 5
What proportion of women with menopausal symptoms seek treatment?
Almost every woman
Around 3/4 of women
Around half of women
Around 1/4 of women
Abbreviations & references
Back
Is VEOZA right her?
for
Many women experience persistent moderate to severe VMS despite of lifestyle modifications or current therapies. VEOZA might provide a non-hormonal alternative for patients with unmet needs, hormone therapy contraindications or with non-hormonal therapy preferences.1,2 VEOZA™ (fezolinetant) is indicated for the treatment of moderate to severe VMS associated with menopause.3,*
How does VEOZA support VMS treatment?
MODE OF ACTION
How do I identify patients who might benefit from VEOZA?
PATIENT PROFILES
*See section 5.1 in SmPC.
MAT-NO-VEO-2025-00051 | Date of preparation 21.10.2025
Abbreviations & references
Back
Is VEOZA right her?
for
Many women experience persistent moderate to severe VMS despite of lifestyle modifications or current therapies. VEOZA might provide a non-hormonal alternative for patients with unmet needs, hormone therapy contraindications or with non-hormonal therapy preferences.1,2 VEOZA™ (fezolinetant) is indicated for the treatment of moderate to severe VMS associated with menopause.3,*
more
Do you want information?
Get the latest updates and events related to VMS and VEOZA
How does VEOZA support VMS treatment?
MODE OF ACTION
How do I identify patients who might benefit from VEOZA?
PATIENT PROFILES
*See section 5.1 in SmPC.
MAT-NO-VEO-2025-00051 | Date of preparation 21.10.2025
Abbreviations & references
MODE OF ACTION
Back
How does VEOZA support VMS treatment?
VEOZA is indicated for the treatment of moderate to severe VMS associated with menopause.1,*
NON-HORMONAL
NK3R ANTAGONIST
Addresses the source of VMS
*See section 5.1 in SmPC.
Abbreviations & references
MODE OF ACTION
Back
How does VEOZA support VMS treatment?
VEOZA is indicated for the treatment of moderate to severe VMS associated with menopause.1,*
NON-HORMONAL
Non-Hormonal Therapy
As a non-hormonal therapy, VEOZA offers an alternative for women who cannot or prefer not to use menopausal hormone therapy. This might provide an alternative to address an unmet need.2,3
NK3R ANTAGONIST
Addresses the source of VMS
*See section 5.1 in SmPC.
Abbreviations & references
MODE OF ACTION
Back
How does VEOZA support VMS treatment?
VEOZA is indicated for the treatment of moderate to severe VMS associated with menopause.1,*
NON-HORMONAL
NK3R ANTAGONIST
NK3R ANTAGONIST
VEOZA is a first-in-class NK3R antagonist that targets KNDy neurons in the hypothalamus, which are a source of VMS.2,3
Addresses the source of VMS
*See section 5.1 in SmPC.
Abbreviations & references
MODE OF ACTION
Back
How does VEOZA support VMS treatment?
VEOZA is indicated for the treatment of moderate to severe VMS associated with menopause.1,*
NON-HORMONAL
NK3R ANTAGONIST
Addresses the source of VMS
By blocking the binding of NKB to the NK3 receptor, VEOZA helps reduce heat signals at their source, offering relief from hot flushes and night sweats.2-4
Addresses the source of VMS
*See section 5.1 in SmPC.
Abbreviations & references
MODE OF ACTION
Back
How does VEOZA support VMS treatment?
Watch VEOZA’s mode of action:
Abbreviations
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Sara*
Maria*
Katarina*
Michelle*
Eligible for MHT, but cautious due to risk profile
Cautious / contraindicated for MHT
Untreated, prefers non-hormonal treatment options
Wants to discuss other non-hormonal options
Sara seeks relief for her VMS and prefers a non-hormonal option due to her underlying health conditions.
Maria is currently untreated due to her medical history, but she is looking for a VMS treatment that suits her needs.
Katarina would like help with her VMS, but does not want hormones.
Michelle has issues with her current treatment, and she wants to explore other non-hormonal treatment options.
Explore
Explore
Explore
Explore
*Hypothetical patient profile.
Abbreviations
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Katarina*
Untreated, prefers non-hormonal treatment options
Katarina would like help with her VMS, but does not want hormones.
About Katarina
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Katarina*
Untreated, prefers non-hormonal treatment options
Katarina would like help with her VMS, but does not want hormones.
Symptoms
VMS began about 6 months ago and have gradually worsened over time.
Hot flushes:
Sudden waves of heat affect her concentration and comfort at work and make her feel uncomfortable during classes.
Night Sweats:
Frequent episodes disrupt her sleep, leaving her soaked and needing to change clothes.
Poor sleep quality due to night sweats impacts Katarina’s next-day energy, making her tired and irritable, affecting her mood and performance.
Sleep disruption:
Low energy:
Katarina feels constantly drained and lacks her usual vitality throughout the day.
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Katarina*
Untreated, prefers non-hormonal treatment options
Katarina would like help with her VMS, but does not want hormones.
Treatment
Looking for:
Non-hormonal
Lasting effect
Less disturbed sleep
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Katarina*
Untreated, prefers non-hormonal treatment options
Katarina would like help with her VMS, but does not want hormones.
How can VEOZA help?
Non-hormonal
VEOZA is a first-in-class NK3R antagonist that targets specific neurons in the hypothalamus, which are a source of VMS.1,2
Lasting effect
Patients taking VEOZA experienced a reduction in the mean daily frequence of VMS episodes, which was sustained up to 52 weeks.3,4 See statistics under footnotes.‡
Less disturbed sleep
Women taking VEOZA reported less bothersome sleep disturbances at Week 12 compared to the placebo group.3-5 See statistics under footnotes.§
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
About Michelle
Michelle*
Wants to discuss other non-hormonal options
Michelle has issues with her current treatment, and she wants to explore other non-hormonal treatment options.
†No SSRIs have an approved indication for the treatment of VMS in Europe (https://www.ema.europa.eu/en/medicines), but they are mentioned in guidelines as a treatment option (https://metodebok.no/index.php?action=topic&item=XfjH5Pzi. Accessed 17.09.2025).
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Symptoms
VMS began 2 years ago and have gradually intensified over time.
Meeting disruptions:
Sudden hot flushes interrupt Michelle’s professional interactions, making her feel embarrassed in front of colleagues and clients.
Sleep fragmentation:
She wakes up 3-4 times nightly, due to drenching night sweats, making her feel exhausted.
Michelle*
Wants to discuss other non-hormonal options
Mood volatility:
Unexpected symptom flare-ups trigger intense irritability and anxiety, that she struggles to manage.
Physical discomfort:
Intense sweating episodes force her to change clothes during the workday, leaving her feeling self-conscious and constantly worried about her appearance.
Michelle has issues with her current treatment, and she wants to explore other non-hormonal treatment options.
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Treatment
Michelle*
†No SSRIs have an approved indication for the treatment of VMS in Europe (https://www.ema.europa.eu/en/medicines), but they are mentioned in guidelines as a treatment option (https://metodebok.no/index.php?action=topic&item=XfjH5Pzi. Accessed 17.09.2025).
Wants to discuss other non-hormonal options
Looking for:
Michelle has issues with her current treatment, and she wants to explore other non-hormonal treatment options.
Non-hormonal
Fewer episodes
Milder episodes
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
How can VEOZA help?
Non-hormonal
VEOZA is a first-in-class NK3R antagonist that targets KNDy neurons in the hypothalamus, which are a source of VMS.1,2
fewer episodes
Michelle*
VEOZA eliminated ~2 out of every 3 VMS episodes (63% reduction) at Week 12.1 See statistics under footnotes.‡
Wants to discuss other non-hormonal options
milder episodes
VEOZA reduced VMS severity of remaining episodes – shifting from moderate/severe at baseline to mostly mild/moderate by Week 12.1,3,4 See statistics under footnotes.§
Michelle has issues with her current treatment, and she wants to explore other non-hormonal treatment options.
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Maria*
Cautious / contraindicated for MHT
Maria is currently untreated due to her medical history, but she is looking for a VMS treatment that suits her needs.
About Maria
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Maria*
Cautious / contraindicated for MHT
Maria is currently untreated due to her medical history, but she is looking for a VMS treatment that suits her needs.
Symptoms
VMS started 18 months ago and continue to worsen, creating additional challenges alongside her already demanding schedule.
Unpredictable episodes:
Hot flushes strike Maria during critical client meetings and high-stakes presentations, and she struggles to regain her composure.
Performance impact:
Disrupted sleep from night sweats leaves her mentally foggy, affecting her ability to perform at the quality level her role demands.
Concentration issues:
VMS make it harder for Maria to maintain her usual focus and decision-making abilities.
Stress cycle:
Her symptoms intensify during high-pressure situations, creating additional workplace anxiety.
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Maria*
Cautious / contraindicated for MHT
Maria is currently untreated due to her medical history, but she is looking for a VMS treatment that suits her needs.
Treatment
Looking for:
Non-hormonal
Lasting effect
EARLY EFFECT
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Maria*
Cautious / contraindicated for MHT
Maria is currently untreated due to her medical history, but she is looking for a VMS treatment that suits her needs.
How can VEOZA help?
Non-hormonal
VEOZA is a first-in-class NK3R antagonist that targets KNDy neurons in the hypothalamus, which are a source of VMS.2,3
Lasting effect
Patients taking VEOZA experienced a reduction in the daily frequency of VMS episodes, which was sustained up to 52 weeks.4,5 See statistics under footnotes.‡
EARLY EFFECT
Patients taking VEOZA experienced a reduction in VMS episodes as early as Week 4.4,5 See statistics under footnotes.§
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Sara*
Eligible for MHT, but cautious due to risk profile
Sara seeks relief for her VMS and prefers a non-hormonal option due to her underlying health conditions.
About Sara
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Sara*
Eligible for MHT, but cautious due to risk profile
Sara seeks relief for her VMS and prefers a non-hormonal option due to her underlying health conditions.
Symptoms
VMS began 2 years ago and have become increasingly frequent and severe, so she contacted her doctor to get help.
Personal discomfort:
Sudden hot flushes drain Sara’s energy and make managing daily tasks challenging.
Sleep disturbances:
Night sweats wake Sara repeatedly, leaving her fatigued for her work and family activities.
Lifestyle limitations:
Symptoms interfere with her work and social coffee dates with friends.
Family impact:
Fatigue and irritability from poor sleep affect her interactions with her husband and teenage son.
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Sara*
Eligible for MHT, but cautious due to risk profile
Sara seeks relief for her VMS and prefers a non-hormonal option due to her underlying health conditions.
Treatment
Looking for:
Studied safety profile for VMS‡
Non-hormonal
Milder episodes
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
PATIENT PROFILES
Back
who
How do I identify patients MIGHT benefit from VEOZA?
Sara*
Eligible for MHT, but cautious due to risk profile
Sara seeks relief for her VMS and prefers a non-hormonal option due to her underlying health conditions.
How can VEOZA help?
Non-hormonal
VEOZA is a first-in-class NK3R antagonist that targets KNDy neurons in the hypothalamus, which are a source of VMS.1,2
milder episodes
VEOZA reduced VMS severity of remaining episodes – shifting from moderate/severe at baseline to mostly mild/moderate by Week 12.1,3,4 See statistics under footnotes.§
Studied safety profile for VMS‡
In the clinical trials, there were no SAEs at an incidence >1% across the total study population. The most common TEAEs (≥3%) were diarrhoea (3.2%) and insomnia (3.0%).5,¶
‡Liver function tests must be performed prior to treatment initiation and monthly during the first three months; thereafter based on clinical judgement. Treatment should not be started or continued if test results meet pre-defined criteria.5 – This section has been rewritten and/or abbreviated compared to the authorised SmPC.
Close
*Hypothetical patient profile.
Footnotes, abbreviations & references
How effective is VEOZA at reducing VMS frequency?
EFFICACY: FREQUENCY
Back
How effective is VEOZA at reducing VMS severity?
EFFICACY: SEVERITY
What should I know about VEOZA’s safety profile?
SAFETY PROFILE
Can treating VMS positively impact sleep quality?
SLEEP IMPROVEMENT
What patients expect from VEOZA?
can
VEOZA (fezolinetant) is a first-in-class, non-hormonal treatment targeting the NKB pathway in the thermoregulatory centre of the hypothalamus. By selectively blocking NK3 receptors, VEOZA restores temperature regulation and reduces VMS frequency and severity.1-3 Explore its clinical efficacy and patient-reported benefits.
What are VEOZA’s key benefits?
BENEFITS
MAT-NO-VEO-2025-00052 | Date of preparation 21.10.2025
Abbreviations & references
How effective is VEOZA at reducing VMS frequency?
EFFICACY: FREQUENCY
Back
Back
How effective is VEOZA at reducing VMS severity?
EFFICACY: SEVERITY
What patients expect from VEOZA?
can
What should I know about VEOZA’s safety profile?
SAFETY PROFILE
VEOZA (fezolinetant) is a first-in-class, non-hormonal treatment targeting the NKB pathway in the thermoregulatory centre of the hypothalamus. By selectively blocking NK3 receptors, VEOZA restores temperature regulation and reduces VMS frequency and severity.1-3 Explore its clinical efficacy and patient-reported benefits.
Can treating VMS positively impact sleep quality?
SLEEP IMPROVEMENT
more
Do you want information?
What are VEOZA’s key benefits?
BENEFITS
Get the latest updates and events related to VMS and VEOZA
MAT-NO-VEO-2025-00052 | Date of preparation 21.10.2025
Abbreviations & references
EFFICACY: FREQUENCY
Back
at
How effective is VEOZA reducing VMS frequency?
Can you guess....
In the SKYLIGHT 1 & 2 trials, VEOZA significantly reduced the average number of VMS episodes per day at Week 12.5 How many episodes were eliminated?
of women will experience VMS during the menopausal transition.1-4
Up to 80%
~2 out of 7 episodes
The frequency of hot flushes varies greatly, from only a few times a month to
~3 out of 5 episodes
several times a day.3
~2 out of 3 episodes
~2 out of 4 episodes
Abbreviations & references
EFFICACY: FREQUENCY
Back
at
How effective is VEOZA reducing VMS frequency?
SKYLIGHT 1 & 2 overview
The efficacy of VEOZA was evaluated in two identical 12-week, randomised, placebo-controlled, double-blind Phase 3 studies (SKYLIGHT 1 & SKYLIGHT 2), followed by a 40-week non-placebo-controlled extension treatment period.1-3
Coprimary endpoints:1-3
Treatment gaps often go unnoticed until they widen. Explore the underlying gaps in VMS care.
TREATMENT GAPS
Learn more about the study design
Mean change from baseline to Week 4 and to Week 12 in:
Study design
Participants
Secondary endpoints:2,3
The following were evaluated from baseline to Week 12:
Inclusion & exclusion criteria
Abbreviations & references
EFFICACY: FREQUENCY
Back
at
How effective is VEOZA reducing VMS frequency?
VEOZA can help reduce your patients’ hot flushes and night sweats1-3
VMS frequency at Week 4
VMS frequency at Week 12
MEAN CHANGE FROM BASELINE
MEAN CHANGE FROM BASELINE
63%
53%
VEOZA
VEOZA
ELIMINATED
episodes by
REDUCED MODERATE TO SEVERE VMS
at Week 12 vs 40% with placebo.1
fewer VMS episodes
at Week 4 vs 32% with placebo.1
fewer VMS episodes
Title
Title
Use this side to give more information about a topic.
Use this side to give more information about a topic.
~2 out of every 3
Subtitle
Subtitle
LS mean change from baseline
LS mean change from baseline
53%
VMS episodes (63% reduction) at Week 12 vs 40% with placebo.1
See Week 4 results
See Week 12 results
at Week 4 vs 32% with placebo.1
Figures adapted from reference 1. LS mean: least square mean estimated from a mixed model for repeated measures analysis of covariance.1 Data contain a pooled analysis of SKYLIGHT 1 and SKYLIGHT 2.1 *Improvement compared with placebo, does not indicate statistical significance.4
Abbreviations & references
EFFICACY: FREQUENCY
Back
at
How effective is VEOZA reducing VMS frequency?
VEOZA provides sustained reduction in VMS frequency for up to 52 weeks1,2
Change in moderate to severe VMS up to Week 521,2
VEOZA showed a reduction in VMS episodes at Weeks 4 & 12, sustaining it through 52 weeks.1,2
VEOZA shows improvements in VMS frequency as early as Week 1.1,2
Switched to VEOZA 45 mg
AT WEEK 12
Reduction in frequency of VMS episodes was sustained through the study period.1,2
Patients initially in the placebo group who switched to VEOZA at Week 12 experienced similar long-term benefits.1,2
Figure adapted from references 1 and 2. Unpooled data from the Phase 3 studies SKYLIGHT 1 and SKYLIGHT 2.
Abbreviations & references
EFFICACY: SEVERITY
Back
at
How effective is VEOZA reducing VMS SEVERITY?
Can you guess....
VMS can vary in intensity, being mild, moderate, or severe.1
Compared to baseline, VEOZA significantly reduced the severity of remaining VMS episodes at 12 weeks.3
MILD
A sensation of heat without sweating.
VEOZA did not show a difference in VMS severity compared to placebo
MODERATE
A sensation of heat with sweating. Ability to continue with activities.
VEOZA shifted VMS severity from moderate-severe to mild-moderate
SEVERE
VEOZA shifted VMS severity from moderate-severe to moderate
A sensation of heat with sweating. Causes cessation of activities.
Patients taking VEOZA only reported improvement in night sweats
VMS last for a median of 7.4 years2
Abbreviations & references
EFFICACY: SEVERITY
Back
at
How effective is VEOZA reducing VMS SEVERITY?
SKYLIGHT 1 & 2 overview
The efficacy of VEOZA was evaluated in two identical 12-week, randomised, placebo-controlled, double-blind Phase 3 studies (SKYLIGHT 1 & SKYLIGHT 2), followed by a 40-week non-placebo-controlled extension treatment period.1-3
Coprimary endpoints:1-3
Treatment gaps often go unnoticed until they widen. Explore the underlying gaps in VMS care.
TREATMENT GAPS
Learn more about the study design
Mean change from baseline to Week 4 and to Week 12 in:
Study design
Participants
Secondary endpoints:2,3
The following were evaluated from baseline to Week 12:
Inclusion & exclusion criteria
Abbreviations & references
EFFICACY: SEVERITY
Back
at
How effective is VEOZA reducing VMS SEVERITY?
VEOZA provides significant reductions in the severity of VMS compared to placebo1
Shift in symptom severity1-3
SEVERE2,3
mild- moderate
moderate- severe
From
To
From a baseline score of 2.4, VEOZA reduced VMS severity to 1.9 at Week 4 and 1.7 at Week 12 compared with 2.1 and 2.0 on placebo, respectively.1-3
MODERATE2,3
Improvements at Weeks 4 & 12 vs placebo
MILD2,3
Figure adapted from references 1-3. *Data contain a pooled analysis of SKYLIGHT 1 and SKYLIGHT 2.1
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Adverse reactions
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1
Adverse reactions for VEOZA 45 mg1
Legend: Common (≥1/100 to <1/10); Not known (cannot be estimated from the available data).
MOST COMMON ADVERSE REACTIONS1
NO SAEs AT AN INCIDENCE >1% IN THE CLINICAL STUDIES1
The most common adverse reactions with VEOZA 45 mg were:1
Use this side of the card to provide more information about a topic. Focus on one concept. Make learning and communication more efficient.
There were no SAEs reported at an incidence greater than 1% across the total study population.1
Use this side of the card to provide more information about a topic. Focus on one concept. Make learning and communication more efficient.
Diarrhoea 3.2%
NO SAEs AT AN INCIDENCE >1% IN THE CLINICAL STUDIES1
MOST COMMON ADVERSE REACTIONS1
Title
On VEOZA, 4 SAEs were reported, the most serious one being endometrial adenocarcinoma (0.1%).1
Title
Write a brief description here
Insomnia 3.0%
Write a brief description here
Table adapted from reference 1. *See SmPC section 4.8.
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Adverse reactions
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1,2
Liver function tests must be performed prior to treatment initiation1,2
Before starting VEOZA Perform a baseline liver function test (LFT) prior to initiating treatment with VEOZA. Treatment should not be started if ALT ≥2× ULN or if total bilirubin is elevated (e.g. 2× ULN).
While using VEOZA Continue LFTs monthly for the first 3 months of treatment. Thereafter, additional monitoring may be conducted based on clinical judgement or when symptoms suggestive of liver injury occur.
Discontinue VEOZA if:
- Transaminase elevations are ≥3× ULN with: total bilirubin >2× ULN or if patients develop symptoms of liver injury
- Transaminase elevations >5× ULN
Patients should be informed about the signs and symptoms of liver injury and should be advised to contact their doctor immediately once these occur.Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Frequently reported TEAEs by preferred term (safety analysis set)2
Adverse reactions
Preferred term, n (%)
Placebo (n=952)
VEOZA (n=1,100)*
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1
TEAEs ≥2% in any group
Additional common TEAEs
Table adapted from reference 2. *The VEOZA group included participants who were re-randomised from placebo after 12 weeks on placebo from SKYLIGHT 1 and 2 studies.2
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Frequently reported TEAEs by preferred term (safety analysis set)2
Adverse reactions
Preferred term, n (%)
Placebo (n=952)
VEOZA (n=1,100)*
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1
TEAEs ≥2% in any group
Additional common TEAEs
Table adapted from reference 2. *The VEOZA group included participants who were re-randomised from placebo after 12 weeks on placebo from SKYLIGHT 1 and 2 studies.2
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Frequently reported TEAEs by preferred term (safety analysis set)2
Adverse reactions
Preferred term, n (%)
Placebo (n=952)
VEOZA (n=1,100)*
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1
TEAEs ≥2% in any group
Table adapted from reference 2. *The VEOZA group included participants who were re-randomised from placebo after 12 weeks on placebo from SKYLIGHT 1 and 2 studies.2
Additional common TEAEs
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Frequently reported TEAEs by preferred term (safety analysis set)2
Adverse reactions
Preferred term, n (%)
Placebo (n=952)
VEOZA (n=1,100)*
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1
TEAEs ≥2% in any group
Additional common TEAEs
Table adapted from reference 2. *The VEOZA group included participants who were re-randomised from placebo after 12 weeks on placebo from SKYLIGHT 1 and 2 studies.2
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Frequently reported TEAEs by preferred term (safety analysis set)2
Adverse reactions
Preferred term, n (%)
Placebo (n=952)
VEOZA (n=1,100)*
The safety of VEOZA was evaluated in Phase 3 clinical studies with 2,203 postmenopausal women receiving VEOZA and from spontaneous reporting in clinical practice.1
TEAEs ≥2% in any group
Table adapted from reference 2. *The VEOZA group included participants who were re-randomised from placebo after 12 weeks on placebo from SKYLIGHT 1 and 2 studies.2
Additional common TEAEs
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
SKYLIGHT 4 overview
SKYLIGHT 4 was a randomised, placebo-controlled, double-blind, 52-week Phase 3 safety study of postmenopausal women, aged ≥40 to ≤65 years, seeking treatment for VMS.1
Primary endpoints1
Learn more about the study design
Frequency and severity of TEAEs
Study design
Percentage of participants with endometrial hyperplasia and endometrial malignancy
Participants
Inclusion & exclusion criteria
Abbreviations & references
SAFETY Profile
Back
about
WHAT SHOULD I KNOW VEOZA’s safety profile?
Endometrial safety
304 postmenopausal women had baseline and post-baseline endometrial biopsies during 52 weeks of treatment.1
In the long-term safety data (SKYLIGHT 1, 2, and 4), endometrial safety of VEOZA was assessed by transvaginal ultrasound and endometrial biopsies.1
Women were monitored for the following outcomes:1
Endometrial HYPERPLASIA or MALIGNANCY
Endometrial ADENOCARCINOMA
Endometrial THICKNESS
Endometrial HYPERPLASIA or MALIGNANCY
Endometrial ADENOCARCINOMA
Endometrial THICKNESS
NO INCREASED RISK
NO INCREASE
ONE CASE (0.1%)
Title
Title
Title
Use this side to give more information about a topic.
Use this side to give more information about a topic.
Use this side to give more information about a topic.
Subtitle
Subtitle
Subtitle
as revealed by endometrial biopsy assessments1
as revealed by transvaginal ultrasound1
of endometrial adenocarcinoma was observed2
References
SLEEP IMPROVEMENT
Back
Can treating VMS positively impact sleep quality?
Can you guess....
VMS are frequently associated with sleep disruption1,2
In the pooled results from SKYLIGHT 1 and 2, a higher proportion of participants receiving VEOZA reported positive change in sleep disturbance at Week 12 compared to placebo.7 Can you guess the proportion of women that reported “much better” sleep?
Did you know hot flushes and night sweats impacted sleep for
82%
of women who reported at least moderate VMS?3,*
Sleep disturbance can trigger further negative effects on women's QoL:
12.5%
Disturbed daily activities1
21.7%
Reduced work productivity1,4
Sleep disruption
Mood disturbance/depression4,5
27.8%
CVD6
32.4%
*From the MEPI Study of postmenopausal women 40 to 65 years old; N=1542 experiencing at least moderate VMS due to menopause.3
Abbreviations & references
SLEEP IMPROVEMENT
Back
Can treating VMS positively impact sleep quality?
VMS can disrupt daily life, with sleep quality being the most affected area for the majority of women going through menopause.1
VMS substantially impacted sleep, affecting
over 80% of women
while also interfering with mood and concentration.1,*
Figure adapted from reference 1. *In a study conducted among 2,703 postmenopausal women in the US aged 40–65 years. Women experiencing VMS of menopause in the previous 4 weeks were asked to identify the activities most affected by their symptoms.1
Abbreviations & references
SLEEP IMPROVEMENT
Back
Can treating VMS positively impact sleep quality?
VEOZA decreases sleep disturbance score and improves patient impression of sleep disturbance1-3
Change in patient-reported sleep disturbance
Sleep disturbance
SCORE
A greater decrease in patient-reported sleep disturbance was observed at Week 12 with VEOZA vs placebo.1-3
Sleep disturbance
CHANGES
Figure adapted from references 1-3.
*The mean change in the PROMIS SD SF 8b total score from the baseline to Week 12 was a key secondary endpoint in the SKYLIGHT trials.1-3 At the individual trial level, p-values were adjusted for multiplicity to control for type 1 error.1-3 Women were not enrolled into SKYLIGHT trials on the basis of sleep disturbance.1-3 †Adjusted for multiplicity.² ‡The pooled analysis of PROMIS SD SF 8b was prespecified and comes from an MMRM analysis of covariance model. The change from baseline is the dependent variable for PROMIS SD SF 8b. Pooled 95% CIs are for descriptive purposes only and are not adjusted for multiplicity. Outcomes among individual studies affect the outcome of the pooled analysis.³ §Distribution of the PGI-C SD at Weeks 4 and 12. PGI-C SD was an exploratory endpoint. Pooled data from SKYLIGHT 1 and 2.3 Data shown for the full analysis set (all randomised participants who received ≥1 dose of study intervention).3
Abbreviations & references
SLEEP IMPROVEMENT
Back
Can treating VMS positively impact sleep quality?
VEOZA decreases sleep disturbance score and improves patient impression of sleep disturbance1-3
Sleep disturbance
SCORE
Patient-reported changes in sleep disturbance3
A higher proportion of participants receiving VEOZA reported positive change in sleep disturbance compared with placebo as measured by PGI-C SD.3
27.8% of patients receiving VEOZA reported "much better" sleep at Week 12, compared to 15.4% on placebo.3
Sleep disturbance
CHANGES
Figure adapted from reference 3.
*The mean change in the PROMIS SD SF 8b total score from the baseline to Week 12 was a key secondary endpoint in the SKYLIGHT trials.1-3 At the individual trial level, p-values were adjusted for multiplicity to control for type 1 error.1-3 Women were not enrolled into SKYLIGHT trials on the basis of sleep disturbance.1-3 †Adjusted for multiplicity.² ‡The pooled analysis of PROMIS SD SF 8b was prespecified and comes from an MMRM analysis of covariance model. The change from baseline is the dependent variable for PROMIS SD SF 8b. Pooled 95% CIs are for descriptive purposes only and are not adjusted for multiplicity. Outcomes among individual studies affect the outcome of the pooled analysis.³ §Distribution of the PGI-C SD at Weeks 4 and 12. PGI-C SD was an exploratory endpoint. Pooled data from SKYLIGHT 1 and 2.3 Data shown for the full analysis set (all randomised participants who received ≥1 dose of study intervention).3
Abbreviations & references
SLEEP IMPROVEMENT
Back
Can treating VMS positively impact sleep quality?
VEOZA decreases sleep disturbance score and improves patient impression of sleep disturbance1-3
Change in patient-reported sleep disturbance
Sleep disturbance
SCORE
A greater decrease in patient-reported sleep disturbance was observed at Week 12 with VEOZA vs placebo.1-3
Sleep disturbance
CHANGES
Figure adapted from references 1-3.
*The mean change in the PROMIS SD SF 8b total score from the baseline to Week 12 was a key secondary endpoint in the SKYLIGHT trials.1-3 At the individual trial level, p-values were adjusted for multiplicity to control for type 1 error.1-3 Women were not enrolled into SKYLIGHT trials on the basis of sleep disturbance.1-3 †Adjusted for multiplicity.² ‡The pooled analysis of PROMIS SD SF 8b was prespecified and comes from an MMRM analysis of covariance model. The change from baseline is the dependent variable for PROMIS SD SF 8b. Pooled 95% CIs are for descriptive purposes only and are not adjusted for multiplicity. Outcomes among individual studies affect the outcome of the pooled analysis.³ §Distribution of the PGI-C SD at Weeks 4 and 12. PGI-C SD was an exploratory endpoint. Pooled data from SKYLIGHT 1 and 2.3 Data shown for the full analysis set (all randomised participants who received ≥1 dose of study intervention).3
Abbreviations & references
BENEFITS
Back
WHAT ARE VEOZA’s key benefits?
VEOZA is a non-hormonal treatment option for your patients1,2
Here’s how VEOZA may help women experiencing VMS:
Non-hormonal treatment1,2
Reduction in VMS frequency and severity as early as Week 13,4
Positive impact on sleep5
Once-daily oral dosing at the time that suits your patient best6
For VEOZA, the most common adverse reactions were diarrhoea (3.2%) and insomnia (3.0%).7 Remember: Liver function tests must be performed at baseline and monthly during the first 3 months of treatment and thereafter on clinical judgement.8,*
*In clinical studies, ALT >3× ULN was observed in 2.1% of women on VEOZA (vs 0.8% on placebo) and AST >3× was observed in 1% of women on VEOZA (vs 0.45% on placebo).7
Abbreviations & references
BENEFITS
Back
WHAT ARE VEOZA’s key benefits?
Watch how VEOZA can be beneficial for your patients:
Back
when
What to consider prescribing VEOZA?
VEOZA is administered once daily, at about the same time each day, offering dosing flexibility for patients.1 This section provides guidance on dosing, administration, and precautions to support appropriate prescribing and patient monitoring.
What is the recommended dosing and administration regimen?
DOSING & ADMINISTRATION
What considerations apply when prescribing VEOZA?
PRECAUTIONS
MAT-NO-VEO-2025-00050 | Date of preparation 21.10.2025
Abbreviations & references
Back
when
What to consider prescribing VEOZA?
VEOZA is administered once daily, at about the same time each day, offering dosing flexibility for patients.1 This section provides guidance on dosing, administration, and precautions to support appropriate prescribing and patient monitoring.
more
Do you want information?
Get the latest updates and events related to VMS and VEOZA
What is the recommended dosing and administration regimen?
DOSING & ADMINISTRATION
What considerations apply when prescribing VEOZA?
PRECAUTIONS
MAT-NO-VEO-2025-00050 | Date of preparation 21.10.2025
Abbreviations & references
DOSING & ADMINISTRATION
Back
and
What is the recommended dosing administration regimen?
1 tablet* a day – once daily, at her convenience1,2
VEOZA is indicated for the treatment of moderate to severe VMS associated with menopause.3,†
Long-term assessment
If a dose is missed or not taken at the usual time, the missed dose should be taken as soon as possible, unless there are fewer than 12 hours before the next scheduled dose.1 Patients should return to the regular schedule the following day.1
Use this side of the card to provide more information about a topic. Focus on one concept. Make learning and communication more efficient.
Use this side of the card to provide more information about a topic. Focus on one concept. Make learning and communication more efficient.
Use this side of the card to provide more information about a topic. Focus on one concept. Make learning and communication more efficient.
Benefit of long-term treatment should be periodically assessed since the duration of VMS can vary by individual.1
VEOZA can be taken with or without food and should be taken with liquids and swallowed whole. The tablet should not be broken, crushed, or chewed.1
VEOZA is taken once daily, at about the same time each day, adapted to each woman's individual schedule and preferences.1
VEOZA 45 mg is taken orally
One dose whenever it suits her the best
About the same time, every day
Title
Title
Title
Write a brief description here
Write a brief description here
Write a brief description here
*Round tablet, 7 mm diameter × 3 mm thickness.2 †See section 5.1 in SmPC.
Abbreviations & references
PRECAUTIONS
Back
when
What considerations apply prescribing VEOZA?
Special warnings and precautions for use
The following contraindications and precautions should be considered when prescribing VEOZA.
Contraindications
special populations
Abbreviations & references
PRECAUTIONS
Back
when
What considerations apply prescribing VEOZA?
Safety considerations
When the patient is using VEOZA, review the safety assessments and monitoring requirements.
BEFORE
Perform a baseline liver function test (LFT) prior to initiating treatment with VEOZA
starting VEOZA
Treatment should not be initiated/started if ALT or AST levels are ≥2× ULN or if total bilirubin is increased (e.g., ≥2× ULN)1,2
using VEOZA
WHILE
Abbreviations & references
PRECAUTIONS
Back
when
What considerations apply prescribing VEOZA?
Safety considerations
When the patient is using VEOZA, review the safety assessments and monitoring requirements.
starting VEOZA
BEFORE
Continue to monitor LFTs monthly for the first 3 months of treatment
Discontinue VEOZA if:
Thereafter, additional monitoring may be conducted based on clinical judgement or when symptoms suggestive of liver injury occur1,2
WHILE
Patients should be informed about the signs and symptoms of liver injury and should be advised to contact their doctor immediately in case these occur.1,2
using VEOZA
Abbreviations & references
PRECAUTIONS
Back
when
What considerations apply prescribing VEOZA?
Safety considerations
When the patient is using VEOZA, review the safety assessments and monitoring requirements.
BEFORE
Perform a baseline liver function test (LFT) prior to initiating treatment with VEOZA
starting VEOZA
Treatment should not be initiated/started if ALT or AST levels are ≥2× ULN or if total bilirubin is increased (e.g., ≥2× ULN)1,2
using VEOZA
WHILE
Abbreviations & references
Abbreviations VMS, vasomotor symptoms. References 1. Constantine GD, Graham S, Clerinx C, Bernick BA, Krassan M, Mirkin S, et al. Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries. Post Reprod Health. 2016 Sep;22(3):112–22. 2. Barber K, Charles A. Barriers to Accessing Effective Treatment and Support for Menopausal Symptoms: A Qualitative Study Capturing the Behaviours, Beliefs and Experiences of Key Stakeholders. Patient Prefer Adherence. 2023 Nov 15;17:2971–80.
NOT CORRECT!
By Week 12, 27.8% of women reported “much better” sleep vs 15.4% on placebo, as measured by the Patient Global Impression of Change in Sleep Disturbance (PGI-C SD).7 PGI-C SD was an exploratory endpoint.7
See more in next slides
12.5%
NOT CORRECT!
By Week 12, 27.8% of women reported “much better” sleep vs 15.4% on placebo, as measured by the Patient Global Impression of Change in Sleep Disturbance (PGI-C SD).7 PGI-C SD was an exploratory endpoint.7
See more in next slides
32.4%
Abbreviations VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.2 03.2025.
Figure adapted from reference 1.
Central nervous system
Central nervous system1
Sleep disruption
Depression and anxiety
Cognitive performance changes
Migraine
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 4. Kaunitz AM, Manson JE. Management of Menopausal Symptoms. Obstet Gynecol. 2015 Oct;126(4):859-76. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 6. Medicines and related procedures [Internet]. [Cited 2025 Aug 27]. Available from: https://www.ema.europa.eu/en/search?search_api_fulltext=menopause
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 4. Kaunitz AM, Manson JE. Management of Menopausal Symptoms. Obstet Gynecol. 2015 Oct;126(4):859-76. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 6. Medicines and related procedures [Internet]. [Cited 2025 Aug 27]. Available from: https://www.ema.europa.eu/en/search?search_api_fulltext=menopause
CORRECT!
VEOZA reduced VMS severity from moderate-severe to mild-moderate at Week 12.
VEOZA shifted VMS severity from moderate-severe to mild-moderate
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -0.67 [(SE 0.04) from baseline (2.40; SD 0.35)] vs -0.42 for the placebo group [(SE 0.04) from baseline (2.42; SD 0.34)].3
See more in next slides
Abbreviations CI, confidence interval; LS, least squares; MMRM, mixed-model for repeated measures; PGI-C SD, Patient Global Impression of Change in Sleep Disturbance; PROMIS SD SF, Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form Questionnaire; VMS, vasomotor symptoms. References 1. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 2. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 3. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
References 1. Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199–215. 2. Santoro NF. Menopause. In: Crandall CJ, Bachman GA, Faubion SS, Klein W, Liu JH, Manson JE, et al, editors. Menopause practice: a clinician’s guide. 6th ed. Pepper Pike (OH): The North American Menopause Society; 2019. p. 1–23. 3. Davis SR, Lambrinoudaki I, Lumsden M, Mishra GD, Pal L, Rees M, et al. Menopause. Nat Rev Dis Primers. 2015 Apr 23;1:15004. 4. Malmberg C, Althin R, Olofsson S. Productivity loss related to vasomotor symptoms (VMS) during menopausal transition among women in the Nordics. IHE-The Swedish Institute for Health Economics; 2024. 5. Harlow SD, Gass M, Hall JE, Lobo R, Maki P, Rebar RW, et al. Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. J Clin Endocrinol Metab. 2012 Apr;97(4):1159–68. 6. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 7. Kuck MJ, Hogervorst E. Stress, depression, and anxiety: psychological complaints across menopausal stages. Front Psychiatry. 2024 Feb 22;15:1323743. 8. Santoro N, Roeca C, Peters BA, Neal-Perry G. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021 Jan 1;106(1):1–15. 9. Gold EB. The timing of the age at which natural menopause occurs. Obstet Gynecol Clin North Am. 2011 Sep;38(3):425–40. 10. Shuster LT, Rhodes DJ, Gostout BS, Grossardt BR, Rocca WA. Premature menopause or early menopause: long-term health consequences. Maturitas. 2010 Feb;65(2):161–6. 11. Swanner KD, Richmond LB. A 65-Year-Old Woman With No Menopause History: A Case Report. Cureus. 2023 Sep 6;15(9):e44792.
References 1. VEOZA SmPC §5.1 03.2025. 2. VEOZA SmPC §4.8 03.2025.
Abbreviations ALP, alkaline phosphatase; COVID-19, coronavirus disease 2019; CPK, creatine phosphokinase; TEAE, treatment emergent adverse event. References 1. VEOZA SmPC §4.8 03.2025. 2. Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147–64.
Increased healthcare utilisation7
VMS
Increased healthcare utilisation7
NOT CORRECT!
VEOZA reduced VMS severity from moderate-severe to mild-moderate at Week 12.
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -0.67 [(SE 0.04) from baseline (2.40; SD 0.35)] vs -0.42 for the placebo group [(SE 0.04) from baseline (2.42; SD 0.34)].3
Patients taking VEOZA only reported improvement in night sweats
See more in next slides
Abbreviations QoL, quality of life; VMS, vasomotor symptoms. References 1. Zhu D, Chung HF, Dobson AJ, Pandeya N, Giles GG, Bruinsma F, et al. Age at natural menopause and risk of incident cardiovascular disease: a pooled analysis of individual patient data. Lancet Public Health. 2019 Nov 1;4(11):e553–64. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Malmberg C, Althin R, Olofsson S. Productivity loss related to vasomotor symptoms (VMS) during menopausal transition among women in the Nordics. IHE-The Swedish Institute for Health Economics; 2024. 4. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 5. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 6. POPU01: Population 1 January by unit, reporting country, age, sex and time [Internet]. [Cited 2025 Jul 18]. Available from: https://pxweb.nordicstatistics.org/pxweb/en/Nordic%20Statistics/Nordic%20Statistics__Demography__Population%20size/POPU01.px/?rxid=4bd7ba15-3c4a-4793-8711-6db1fc878223
Sleep disturbance3-6
4,6
6,13
Sleep disturbance
Reduced work productivity3,5,7
Mood disturbance / depression3-5
VMS and sleep
- Hot flushes are strongly correlated with insomnia and poor sleep.3,4,6
- In one study, 93.8% of women with moderate to severe VMS reported sleep interruptions from overheating and difficulty returning to sleep.5
Sleep disturbance subsequently can affect mood, work productivity, and daily and social activities, and is shown to be correlated to increased cardiovascular risk.4,6,14,15 Reversely, work strain and impaired mood may also worsen sleep6,15 — click on each to learn more.14
13
Daily activities3,5
CVD11,12
VMS
Footnotes §MILDER EPISODES: The pooled result showed a reduction in VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 ¶STUDIED SAFETY PROFILE FOR VMS: The safety of VEOZA was evaluated in Phase 3 clinical studies with 2203 postmenopausal women and from spontaneous reporting in clinical practice.5 Abbreviations BMI, body mass index; CV, cardiovascular; KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SAE, serious adverse event; SD, standard deviation; SE, standard error; TEAE, treatment-emergent adverse event; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. VEOZA SmPC §4.8 03.2025.
Abbreviations NKB, neurokinin B; NK3R, neurokinin 3 receptor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.1 03.2025. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Jayasena CN, Comninos AN, Stefanopoulou E, Buckley A, Narayanaswamy S, Izzi-Engbeaya C, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015 Feb 16;5:8466.
Sleep disturbance3-6
Daily activities3,5
- A 2025 Nordic study showed that moderate to severe VMS reduced daily activities by 30.6%.3
Women with inadequate sleep related to VMS report being slower, struggling with tasks, and feeling tired during the day5 — click on each to learn more.Daily activities3,5
VMS
NOT CORRECT!
VMS often persists longer than that, with a median persistence of 7.4 years.1 VMS varies widely among women, but prevalence generally peaks within the first two years after the final menstrual period.2
Learn more in the section: Menopause.
5.6 years
NOT CORRECT!
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -6.94 [(SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].5
See more in next slides
VEOZA reduced the average daily frequency of hot flushes and night sweats by 63%.
~2 out of 4 episodes
Abbreviations VMS, vasomotor symptoms. References 1. Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachman GA, Faubion SS, Klein W, Liu JH, Manson JE, et al, editors. Menopause practice: a clinician’s guide. 6th ed. Pepper Pike (OH): The North American Menopause Society; 2019. p. 43–55. 2. Mishra GD, Dobson AJ. Using longitudinal profiles to characterize women's symptoms through midlife: results from a large prospective study. Menopause. 2012 May;19(5):549–55. 3. Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr 1;175(4):531–9.
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94.
Abbreviations CVD, cardiovascular disease; MEPI, Menopause Epidemiology; PGI-C SD, Patient Global Impression of Change in Sleep Disturbance; QoL, quality of life; VMS, vasomotor symptoms. References 1. Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005 Aug 5;3:47. 2. English M, Stoykova B, Slota C, Doward L, Siddiqui E, Crawford R, et al. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS sleep disturbance and sleep-related impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes. 2021 Apr 26;5(1):37. 3. Williams RE, Levine KB, Kalilani L, Lewis J, Clark RV. Menopause-specific questionnaire assessment in US population-based study shows negative impact on health-related quality of life. Maturitas. 2009 Feb 20;62(2):153–9. 4. Baker FC, Lampio L, Saaresranta T, Polo-Kantola P. Sleep and sleep disorders in the menopausal transition. Sleep Med Clin. 2018 Sep;13(3):443–56. 5. Lett HS, Blumenthal JA, Babyak MA, Sherwood A, Strauman T, Robins C, et al. Depression as a risk factor for coronary artery disease: evidence, mechanisms, and treatment. Psychosom Med. 2004 May–Jun;66(3):305–15. 6. Cappuccio FP, Cooper D, D'Elia L, Strazzullo P, Miller MA. Sleep duration predicts cardiovascular outcomes: a systematic review and meta-analysis of prospective studies. Eur Heart J. 2011 Jun 1;32(12):1484–92. 7. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
Cognition impairment4,5 and CNS alterations9,10
VMS
Cognition impairment4,5 and CNS alterations9,10
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. VEOZA SmPC §4.1 03.2025.
Abbreviations VMS, vasomotor symptoms. References 1. Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199–215. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89.
NOT CORRECT!
VMS are very common, affecting up to 80% of women during the menopausal transition.1,2
Learn more in the section: Life with VMS.
Up to 5 in 10 women experience VMS
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 4. Kaunitz AM, Manson JE. Management of Menopausal Symptoms. Obstet Gynecol. 2015 Oct;126(4):859-76. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 6. Medicines and related procedures [Internet]. [Cited 2025 Aug 27]. Available from: https://www.ema.europa.eu/en/search?search_api_fulltext=menopause
CORRECT!
KNDy neurons become hyperactive due to loss of oestrogen inhibition, which overstimulates the thermoregulatory centre in the hypothalamus. This triggers VMS and provides a basis for developing targeted non-hormonal therapies.1-3
Learn more in the section: Mechanism of VMS.
They become hyperactive due to loss of oestrogen inhibition, disrupting thermoregulation
PERIMENOPAUSE
This phase involves endocrine, physical, and temporary psychologic changes. It is marked by a decreasing number of ovarian follicles, which leads to changes in the menstrual pattern.2,5 During this phase, women experience:
Early perimenopause Irregular menstrual bleeding of consecutive menstrual cycles.5
Late perimenopause When menstrual bleeding has not occurred in the last 60 days, but has happened in the previous 12 months.5
Figure adapted from reference 4.
perimenopause
35-45 yr Last regular menstrual cycle
12 months with amenorrhoea
Footnotes §MILDER EPISODES: The pooled result showed a reduction in VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 ¶STUDIED SAFETY PROFILE FOR VMS: The safety of VEOZA was evaluated in Phase 3 clinical studies with 2203 postmenopausal women and from spontaneous reporting in clinical practice.5 Abbreviations BMI, body mass index; CV, cardiovascular; KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SAE, serious adverse event; SD, standard deviation; SE, standard error; TEAE, treatment-emergent adverse event; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. VEOZA SmPC §4.8 03.2025.
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.4,5 §SIGNIFICANT EFFECT FROM WEEK 4: The pooled results from SKYLIGHT 1 and 2 demonstrated a clinically meaningful decrease from baseline at Week 4 compared to placebo (reduction of 2 or more VMS episodes per 24h; p<0.001). At Week 4, patients experienced a 52.84% reduction in the average daily frequency of hot flushes and night sweats in the VEOZA group [-5.79 (SE 0.23) from baseline 11.10 (SD 6.45)] compared to a 31.96% reduction in the placebo group [-3.51 (SE 0.22) from baseline 11.04 (SD 4.46)].2 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; VMS, vasomotor symptoms. References 1. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 5. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
NOT CORRECT!
VMS are very common, affecting up to 80% of women during the menopausal transition.1,2
Learn more in the section: Life with VMS.
Up to 2 in 10 women experience VMS
Abbreviations VMS, vasomotor symptoms.
NOT CORRECT!
VMS often persists longer than that, with a median persistence of 7.4 years.1 VMS varies widely among women, but prevalence generally peaks within the first two years after the final menstrual period.2
Learn more in the section: Menopause.
4.8 years
Abbreviations BLN, baseline; SE, standard error; VMS, vasomotor symptoms. References 1. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 2. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
Abbreviations QoL, quality of life; VMS, vasomotor symptoms. References 1. Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr 1;175(4):531–9. 2. Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause. 2014 Sep 1;21(9):924–32. 3. Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Granger AL, Fehnel SE, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Climacteric. 2008 Feb;11(1):32–43. 4. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 5. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86.
MENOPAUSE
Menopause is a significant milestone that marks the end of a woman’s reproductive years.2
Premature menopause10
Early menopause10,11
Typical onset of menopause10,11
Late menopause11
51
5%
1%
5%
of women
of women
of women
average age
Age
<40
45
51
>55
Figure adapted from reference 4.
menopause
51 yr on average Final menstrual period
Abbreviations QoL, quality of life; VMS, vasomotor symptoms. References 1. Zhu D, Chung HF, Dobson AJ, Pandeya N, Giles GG, Bruinsma F, et al. Age at natural menopause and risk of incident cardiovascular disease: a pooled analysis of individual patient data. Lancet Public Health. 2019 Nov 1;4(11):e553–64. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Malmberg C, Althin R, Olofsson S. Productivity loss related to vasomotor symptoms (VMS) during menopausal transition among women in the Nordics. IHE-The Swedish Institute for Health Economics; 2024. 4. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 5. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 6. POPU01: Population 1 January by unit, reporting country, age, sex and time [Internet]. [Cited 2025 Jul 18]. Available from: https://pxweb.nordicstatistics.org/pxweb/en/Nordic%20Statistics/Nordic%20Statistics__Demography__Population%20size/POPU01.px/?rxid=4bd7ba15-3c4a-4793-8711-6db1fc878223
Study design2,3,*
Fezolinetant 30 mg
Placebo
Fezolinetant 45 mg
Visit:End of treatment
Randomisation 1:1:1 n=1,022
Visit:Follow-up
Screening
Fezolinetant 30 mg
Fezolinetant 30 mg
Fezolinetant 45 mg
Fezolinetant 45 mg
DAY 1
WEEK 4
WEEK 12
40-WEEK EXTENSION
WEEK 52
WEEK 55
Figure adapted from references 2 and 3. *The study design includes 30 mg arms to be consistent with SKYLIGHT 1 and SKYLIGHT 2. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to the 45 mg dose.
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94.
Inclusion and exclusion criteria1-3
Inclusion criteria:
Exclusion criteria:
Abbreviations BMI, body mass index; TEAE, treatment emergent adverse event; VMS, vasomotor symptoms. References 1. Neal-Perry G, Cano A, Lederman S, Nappi RE, Santoro N, Wolfman W, et al. Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial. Obstet Gynecol. 2023 Apr 1;141(4):737–47.
Abbreviations VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.2 03.2025.
Abbreviations NKB, neurokinin B; NK3R, neurokinin 3 receptor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.1 03.2025. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Jayasena CN, Comninos AN, Stefanopoulou E, Buckley A, Narayanaswamy S, Izzi-Engbeaya C, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015 Feb 16;5:8466.
Abbreviations ALP, alkaline phosphatase; COVID-19, coronavirus disease 2019; CPK, creatine phosphokinase; TEAE, treatment emergent adverse event. References 1. VEOZA SmPC §4.8 03.2025. 2. Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147–64.
Sleep disturbance3-6
6,13
CVD11,12
Mood disturbance / depression3-5
VMS and cardiovascular health
- Hot flushes are associated with poorer endothelial function and greater aortic calcification, independent of CVD risk factors and sex hormone status.11
- VMS are related to higher carotid intima media thickness and carotid plaque, independent of standard risk factors and sex hormones.11,12
Sleep disturbances, such as short sleep duration, are associated with increased risk of CVD and CVD related mortality14 — click on each to learn more.14
13
CVD11,12
VMS
PREMENOPAUSE
Premenopause includes the reproductive stages (early, peak, and late), and the menopausal transition (early and late).5 Up until perimenopause, women present:
Figure adapted from reference 4.
Premenopause
11-15 yr Menarche
Abbreviations Avg., average; VMS, vasomotor symptoms. References 1. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 2. Nordic Cooperation. 10 facts about gender equality [Internet]. Copenhagen: Nordic Council of Ministers; [cited 2025 Jul 28]. Available from: https://www.norden.org/en/information/10-facts-about-gender-equality 3. Department for Work and Pensions. Menopause and the workplace: How to enable fulfilling working lives – government response [Internet]. London: GOV.UK; 2022 Jul [updated 2022 Jul; cited 2025 Aug 18]. Available from: https://www.gov.uk/government/publications/menopause-and-the-workplace-how-to-enable-fulfilling-working-lives-government-response/menopause-and-the-workplace-how-to-enable-fulfilling-working-lives-government-response 4. Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199–215. 5. Larsen M, Holt H, Larsen MR. Et kønsopdelt arbejdsmarked [Internet]. Copenhagen: VIVE – The Danish Center for Social Science Research; 2016 [cited 2025 Aug 18]. Available from: https://pure.vive.dk/ws/files/416934/1615_Et_k_nsdopdelt_arbejdsmarked.pdf 6. Malmberg C, Althin R, Olofsson S. Productivity loss related to vasomotor symptoms (VMS) during menopausal transition among women in the Nordics. IHE-The Swedish Institute for Health Economics; 2024.
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Rance NE, Dacks PA, Mittelman-Smith MA, Romanovsky AA, Krajewski-Hall SJ. Modulation of body temperature and LH secretion by hypothalamic KNDy (kisspeptin, neurokinin B and dynorphin) neurons: a novel hypothesis on the mechanism of hot flushes. Front Neuroendocrinol. 2013 Aug;34(3):211–27. 3. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132.
CORRECT!
VMS has a median persistence of 7.4 years.1 VMS varies widely among women, but prevalence generally peaks within the first two years after the final menstrual period.2
Learn more in the section: Menopause.
7.4 years
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 4. Kaunitz AM, Manson JE. Management of Menopausal Symptoms. Obstet Gynecol. 2015 Oct;126(4):859-76. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 6. Medicines and related procedures [Internet]. [Cited 2025 Aug 27]. Available from: https://www.ema.europa.eu/en/search?search_api_fulltext=menopause
NOT CORRECT!
A study showed that 43–50% of women with menopausal symptoms do not seek any treatment, depending on the country, highlighting the large treatment gap in menopause care. Many women avoid seeking care due to discomfort discussing symptoms or embarrassment.1,2
Learn more in the section: Treatment options.
Around 3/4 of women
Epigenetic ageing8
VMS
Epigenetic ageing8
Physical health5
NOT CORRECT!
A study showed that 43–50% of women with menopausal symptoms do not seek any treatment, depending on the country, highlighting the large treatment gap in menopause care. Many women avoid seeking care due to discomfort discussing symptoms or embarrassment.1,2
Learn more in the section: Treatment options.
Almost every woman
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94.
Abbreviations HCPs, healthcare professionals; VMS, vasomotor symptoms. References 1. DePree B, Houghton K, Shiozawa A, Esterberg E, King DD, Kim J, et al. Treatment and resource utilization for menopausal symptoms in the United States: a retrospective review of real-world evidence from US electronic health records. Menopause. 2023 Jan 1;30(1):70–9. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Barber K, Charles A. Barriers to Accessing Effective Treatment and Support for Menopausal Symptoms: A Qualitative Study Capturing the Behaviours, Beliefs and Experiences of Key Stakeholders. Patient Prefer Adherence. 2023 Nov 15;17:2971–80. 4. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 5. Constantine GD, Graham S, Clerinx C, Bernick BA, Krassan M, Mirkin S, et al. Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries. Post Reprod Health. 2016 Sep;22(3):112–22. 6. Dintakurti N, Kalyanasundaram S, Jha P, Talaulikar V. An online survey and interview of GPs in the UK for assessing their satisfaction regarding the medical training curriculum and NICE guidelines for the management of menopause. Post Reprod Health. 2022 Sep;28(3):137–41.
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94.
NOT CORRECT!
KNDy neurons become hyperactive due to loss of oestrogen inhibition, which overstimulates the thermoregulatory centre in the hypothalamus. This triggers VMS and provides a basis for developing targeted non-hormonal therapies.1-3
Learn more in the section: Mechanism of VMS.
They respond to temperature changes by regulating norepinephrine release
Muscoskeletal system
Musculoskeletal system1
Joint pain
Sarcopenia (loss of muscle mass)
Abbreviations ALP, alkaline phosphatase; COVID-19, coronavirus disease 2019; CPK, creatine phosphokinase; TEAE, treatment emergent adverse event. References 1. VEOZA SmPC §4.8 03.2025. 2. Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147–64.
Abbreviations VMS, vasomotor symptoms. References 1. Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachmann GA, Faubion SS, et al. Menopause practice: a clinician’s guide. 6th ed. Pepper Pike (OH): The North American Menopause Society; 2019. p. 43–55. 2. Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr 1;175(4):531–9. 3. VEOZA SmPC §5.1 03.2025.
Abbreviations QoL, quality of life; VMS, vasomotor symptoms. References 1. Zhu D, Chung HF, Dobson AJ, Pandeya N, Giles GG, Bruinsma F, et al. Age at natural menopause and risk of incident cardiovascular disease: a pooled analysis of individual patient data. Lancet Public Health. 2019 Nov 1;4(11):e553–64. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Malmberg C, Althin R, Olofsson S. Productivity loss related to vasomotor symptoms (VMS) during menopausal transition among women in the Nordics. IHE-The Swedish Institute for Health Economics; 2024. 4. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 5. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 6. POPU01: Population 1 January by unit, reporting country, age, sex and time [Internet]. [Cited 2025 Jul 18]. Available from: https://pxweb.nordicstatistics.org/pxweb/en/Nordic%20Statistics/Nordic%20Statistics__Demography__Population%20size/POPU01.px/?rxid=4bd7ba15-3c4a-4793-8711-6db1fc878223
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 4. Kaunitz AM, Manson JE. Management of Menopausal Symptoms. Obstet Gynecol. 2015 Oct;126(4):859-76. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 5. Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. 6. Medicines and related procedures [Internet]. [Cited 2025 Aug 27]. Available from: https://www.ema.europa.eu/en/search?search_api_fulltext=menopause
Physical health5
- VMS are often accompanied by physical symptoms such as dizziness, nausea, headaches, or ringing in the ears, followed by a feeling of being physically drained.5
VMS are also linked to accelerated epigenetic aging, which in turn is associated with higher risk of cancers, reduced physical function, Alzheimer’s disease, coronary heart disease, and all-cause mortality8 — click on each to learn more.VMS
Epigenetic ageing8
Physical health5
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.4,5 §SIGNIFICANT EFFECT FROM WEEK 4: The pooled results from SKYLIGHT 1 and 2 demonstrated a clinically meaningful decrease from baseline at Week 4 compared to placebo (reduction of 2 or more VMS episodes per 24h; p<0.001). At Week 4, patients experienced a 52.84% reduction in the average daily frequency of hot flushes and night sweats in the VEOZA group [-5.79 (SE 0.23) from baseline 11.10 (SD 6.45)] compared to a 31.96% reduction in the placebo group [-3.51 (SE 0.22) from baseline 11.04 (SD 4.46)].2 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; VMS, vasomotor symptoms. References 1. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 5. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
Social / relationship4,5
- Becoming flushed and sweating in a social or work setting may cause anxiety and lead to social isolation.4
Sleep disturbance and irritability caused by VMS can strain familial and social relationships4 — click on each to learn more.VMS
Social / relationship4,5
NOT CORRECT!
KNDy neurons become hyperactive due to loss of oestrogen inhibition, which overstimulates the thermoregulatory centre in the hypothalamus. This triggers VMS and provides a basis for developing targeted non-hormonal therapies.1-3
Learn more in the section: Mechanism of VMS.
They stimulate sweat glands directly through autonomic pathways
Inclusion and exclusion criteria1-3
Inclusion criteria:
Exclusion criteria:
Abbreviations VMS, vasomotor symptoms. References 1. Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Granger AL, Fehnel SE, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Climacteric. 2008 Feb;11(1):32–43.
NOT CORRECT!
KNDy neurons become hyperactive due to loss of oestrogen inhibition, which overstimulates the thermoregulatory centre in the hypothalamus. This triggers VMS and provides a basis for developing targeted non-hormonal therapies.1-3
Learn more in the section: Mechanism of VMS.
They regulate vasodilation through spinal cord reflexes
Abbreviations ALT, alanine aminotransferase; AST, aspartate aminotransferase; LFT, liver function test; ULN, upper limit of normal. References 1. VEOZA SmPC §4.4 03.2025. 2. VEOZA SmPC §4.8 03.2025.
Abbreviations ALT, alanine aminotransferase; AST, aspartate aminotransferase; LFT, liver function test; ULN, upper limit of normal. References 1. VEOZA SmPC §4.4 03.2025. 2. VEOZA SmPC §4.8 03.2025.
NOT CORRECT!
VMS often persists longer than that, with a median persistence of 7.4 years.1 VMS varies widely among women, but prevalence generally peaks within the first two years after the final menstrual period.2
Learn more in the section: Menopause.
2.7 years
CORRECT!
By Week 12, 27.8% of women reported “much better” sleep vs 15.4% on placebo, as measured by the Patient Global Impression of Change in Sleep Disturbance (PGI-C SD).7 PGI-C SD was an exploratory endpoint.7
See more in next slides
27.8%
NOT CORRECT!
By Week 12, 27.8% of women reported “much better” sleep vs 15.4% on placebo, as measured by the Patient Global Impression of Change in Sleep Disturbance (PGI-C SD).7 PGI-C SD was an exploratory endpoint.7
See more in next slides
21.7%
Abbreviations BMI, body mass index; CYP1A2, cytochrome P450 1A2; PROMIS SD SF, Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
Abbreviations CI, confidence interval; LS, least squares; MMRM, mixed-model for repeated measures; PGI-C SD, Patient Global Impression of Change in Sleep Disturbance; PROMIS SD SF, Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form Questionnaire; VMS, vasomotor symptoms. References 1. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 2. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 3. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
Sleep disturbance3-6
6,13
Mood disturbance / depression3-5
Mood disturbance / depression3-5
VMS and mood
- VMS are linked to mood disturbances such as irritability, emotional distress, and embarrassment in both social and professional settings due to visible symptoms and odours.5
- VMS are associated with depressive symptoms in peri- and postmenopause, independent of oestrogen status.15
Mood disturbances from VMS can significantly reduce quality of life.4 Mood and sleep disturbances are bi-directionally related, creating a self-reinforcing cycle. Furthermore, depression has shown to increase risk of coronary heart disease by 1.5–2 times in healthy individuals6,13,15 — click on each to learn more.13
CVD11,12
VMS
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.3,4 §LESS DISTURBED SLEEP: The pooled analysis from SKYLIGHT 1 and 2 showed a greater decrease in patient-reported sleep disturbances at Week 12 with VEOZA vs placebo (-4.8 and -3.3 from baseline, respectively; treatment difference: -1.5 [95% CI: -2.5, -0.5]).5 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; OTC, over-the-counter; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
Footnotes §MILDER EPISODES: The pooled result showed a reduction in VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 ¶STUDIED SAFETY PROFILE FOR VMS: The safety of VEOZA was evaluated in Phase 3 clinical studies with 2203 postmenopausal women and from spontaneous reporting in clinical practice.5 Abbreviations BMI, body mass index; CV, cardiovascular; KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SAE, serious adverse event; SD, standard deviation; SE, standard error; TEAE, treatment-emergent adverse event; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. VEOZA SmPC §4.8 03.2025.
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.4,5 §SIGNIFICANT EFFECT FROM WEEK 4: The pooled results from SKYLIGHT 1 and 2 demonstrated a clinically meaningful decrease from baseline at Week 4 compared to placebo (reduction of 2 or more VMS episodes per 24h; p<0.001). At Week 4, patients experienced a 52.84% reduction in the average daily frequency of hot flushes and night sweats in the VEOZA group [-5.79 (SE 0.23) from baseline 11.10 (SD 6.45)] compared to a 31.96% reduction in the placebo group [-3.51 (SE 0.22) from baseline 11.04 (SD 4.46)].2 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; VMS, vasomotor symptoms. References 1. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 5. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
Footnotes §MILDER EPISODES: The pooled result showed a reduction in VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 ¶STUDIED SAFETY PROFILE FOR VMS: The safety of VEOZA was evaluated in Phase 3 clinical studies with 2203 postmenopausal women and from spontaneous reporting in clinical practice.5 Abbreviations BMI, body mass index; CV, cardiovascular; KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SAE, serious adverse event; SD, standard deviation; SE, standard error; TEAE, treatment-emergent adverse event; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. VEOZA SmPC §4.8 03.2025.
Abbreviations ALT, alanine aminotransferase; AST, aspartate aminotransferase; LFT, liver function test; ULN, upper limit of normal. References 1. VEOZA SmPC §4.4 03.2025. 2. VEOZA SmPC §4.8 03.2025.
Weight & metabolism
Weight and metabolic changes1
Weight gain
Increased visceral adiposity
Study design1,*
Placebo
Visit:End of treatment
Randomisation 1:1:1 n=1,830
Visit:Follow-up
Screening
Fezolinetant 30 mg
Fezolinetant 45 mg
DAY 1
52 WEEKS
WEEK 52
WEEK 55
Figure adapted from reference 1. *The study design includes 30 mg arms to be consistent with SKYLIGHT 4. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to the 45 mg dose.
Abbreviations NKB, neurokinin B; NK3R, neurokinin 3 receptor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.1 03.2025. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Jayasena CN, Comninos AN, Stefanopoulou E, Buckley A, Narayanaswamy S, Izzi-Engbeaya C, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015 Feb 16;5:8466.
Footnotes ‡FEWER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction in VMS frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in the average daily frequency of hot flushes and night sweats at Week 12 was 63% in the VEOZA group [-6.94 (SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].1 §MILDER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; SSRI, selective serotonin reuptake inhibitor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102.
Abbreviations VMS, vasomotor symptoms. References 1. DePree B, Houghton K, Shiozawa A, Esterberg E, King DD, Kim J, et al. Treatment and resource utilization for menopausal symptoms in the United States: a retrospective review of real-world evidence from US electronic health records. Menopause. 2023 Jan 1;30(1):70–9. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Constantine GD, Graham S, Clerinx C, Bernick BA, Krassan M, Mirkin S, et al. Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries. Post Reprod Health. 2016 Sep;22(3):112–22.
Abbreviations VMS, vasomotor symptoms. References 1. Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr 1;175(4):531–9. 2. Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause. 2014 Sep 1;21(9):924–32.
CORRECT!
Blocking NKB-mediated activation of KNDy neurons restores normal KNDy activity, reducing overstimulation of thermoregulatory pathways, targeting the source of VMS to reduce their frequency and severity.1-3
Learn more in the section: Mechanism of VMS.
Because it restores normal KNDy neuron activity, reducing overstimulation of thermoregulatory pathways
Abbreviations HCPs, healthcare professionals; VMS, vasomotor symptoms. References 1. DePree B, Houghton K, Shiozawa A, Esterberg E, King DD, Kim J, et al. Treatment and resource utilization for menopausal symptoms in the United States: a retrospective review of real-world evidence from US electronic health records. Menopause. 2023 Jan 1;30(1):70–9. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Barber K, Charles A. Barriers to Accessing Effective Treatment and Support for Menopausal Symptoms: A Qualitative Study Capturing the Behaviours, Beliefs and Experiences of Key Stakeholders. Patient Prefer Adherence. 2023 Nov 15;17:2971–80. 4. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 5. Constantine GD, Graham S, Clerinx C, Bernick BA, Krassan M, Mirkin S, et al. Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries. Post Reprod Health. 2016 Sep;22(3):112–22. 6. Dintakurti N, Kalyanasundaram S, Jha P, Talaulikar V. An online survey and interview of GPs in the UK for assessing their satisfaction regarding the medical training curriculum and NICE guidelines for the management of menopause. Post Reprod Health. 2022 Sep;28(3):137–41.
Abbreviations NKB, neurokinin B; NK3, neurokinin 3; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Jayasena CN, Comninos AN, Stefanopoulou E, Buckley A, Narayanaswamy S, Izzi-Engbeaya C, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015 Feb 16;5:8466.
Inclusion and exclusion criteria1
Inclusion criteria:
Exclusion criteria:
NOT CORRECT!
VEOZA reduced VMS severity from moderate-severe to mild-moderate at Week 12.
VEOZA did not show a difference in VMS severity compared to placebo
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -0.67 [(SE 0.04) from baseline (2.40; SD 0.35)] vs -0.42 for the placebo group [(SE 0.04) from baseline (2.42; SD 0.34)].3
See more in next slides
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; NKB, neurokinin B; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94.
Footnotes ‡FEWER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction in VMS frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in the average daily frequency of hot flushes and night sweats at Week 12 was 63% in the VEOZA group [-6.94 (SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].1 §MILDER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; SSRI, selective serotonin reuptake inhibitor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102.
Study participants1-3
The studies consisted of postmenopausal women with a minimum average of 7 to 8 moderate to severe VMS per day or 50 to 60 per week within 10 days before randomisation:
*Baseline demographics also include women receiving fezolinetant 30 mg. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to the 45 mg dose.
CORRECT!
A study showed that 43–50% of women with menopausal symptoms do not seek any treatment, depending on the country, highlighting the large treatment gap in menopause care. Many women avoid seeking care due to discomfort discussing symptoms or embarrassment.1,2
Learn more in the section: Treatment options.
Around half of women
NOT CORRECT!
Blocking NKB-mediated activation of KNDy neurons restores normal KNDy activity, reducing overstimulation of thermoregulatory pathways, targeting the source of VMS to reduce their frequency and severity.1-3
Learn more in the section: Mechanism of VMS.
Because it promotes cooling by directly stimulating peripheral vasodilation
NOT CORRECT!
A study showed that 43–50% of women with menopausal symptoms do not seek any treatment, depending on the country, highlighting the large treatment gap in menopause care. Many women avoid seeking care due to discomfort discussing symptoms or embarrassment.1,2
Learn more in the section: Treatment options.
Around 1/4 of women
Abbreviations VMS, vasomotor symptyoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489–501.
NOT CORRECT!
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -6.94 [(SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].5
See more in next slides
VEOZA reduced the average daily frequency of hot flushes and night sweats by 63%.
~3 out of 5 episodes
Abbreviations NKB, neurokinin B; NK3, neurokinin 3; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Jayasena CN, Comninos AN, Stefanopoulou E, Buckley A, Narayanaswamy S, Izzi-Engbeaya C, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015 Feb 16;5:8466.
Abbreviations ALT, alanine aminotransferase; LFT, liver function test; ULN, upper limit of normal. References 1. VEOZA SmPC §4.4 03.2025. 2. VEOZA SmPC §4.8 03.2025.
Self-care5
VMS
Self-care5
CORRECT!
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -6.94 [(SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].5
See more in next slides
VEOZA reduced the average daily frequency of hot flushes and night sweats by 63%.
~2 out of 3 episodes
Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Rance NE, Dacks PA, Mittelman-Smith MA, Romanovsky AA, Krajewski-Hall SJ. Modulation of body temperature and LH secretion by hypothalamic KNDy (kisspeptin, neurokinin B and dynorphin) neurons: a novel hypothesis on the mechanism of hot flushes. Front Neuroendocrinol. 2013 Aug;34(3):211–27. 3. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132.
Footnotes ‡FEWER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction in VMS frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in the average daily frequency of hot flushes and night sweats at Week 12 was 63% in the VEOZA group [-6.94 (SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].1 §MILDER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; SSRI, selective serotonin reuptake inhibitor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102.
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.3,4 §LESS DISTURBED SLEEP: The pooled analysis from SKYLIGHT 1 and 2 showed a greater decrease in patient-reported sleep disturbances at Week 12 with VEOZA vs placebo (-4.8 and -3.3 from baseline, respectively; treatment difference: -1.5 [95% CI: -2.5, -0.5]).5 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; OTC, over-the-counter; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
NOT CORRECT!
Blocking NKB-mediated activation of KNDy neurons restores normal KNDy activity, reducing overstimulation of thermoregulatory pathways, targeting the source of VMS to reduce their frequency and severity.1-3
Learn more in the section: Mechanism of VMS.
Because it stimulates oestrogen production through the hypothalamic-pituitary feedback loop
CORRECT!
Up to 80% of women experience VMS during the menopausal transition.1,2
Learn more in the section: Life with VMS.
Up to 8 in 10 women experience VMS
Abbreviations ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal; VMS, vasomotor symptoms. References 1. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 2. VEOZA SmPC §5.1 03.2025. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999. 6. VEOZA SmPC §4.2 03.2025. 7. VEOZA SmPC §4.8 03.2025. 8. VEOZA SmPC §4.4 03.2025.
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms.
Abbreviations SE, standard error; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
Abbreviations SD, standard deviation; SE, standard error; VMS, vasomotor symptoms. References 1. Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr 1;175(4):531–9. 2. Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause. 2014 Sep 1;21(9):924–32. 3. Williams RE, Kalilani L, DiBenedetti DB, Zhou X, Granger AL, Fehnel SE, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Climacteric. 2008 Feb;11(1):32–43. 4. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 5. VEOZA SmPC §5.1 03.2025.
Abbreviations CYP1A2, cytochrome P540 1A2; eGFR, estimated Glomerular Filtration Rate. References 1. VEOZA SmPC §4.3 03.2025. 2. VEOZA SmPC §4.5 03.2025. 3. VEOZA SmPC §4.6 03.2025. 4. VEOZA SmPC §4.2 03.2025.
Abbreviations ALP, alkaline phosphatase; COVID-19, coronavirus disease 2019; CPK, creatine phosphokinase; TEAE, treatment emergent adverse event. References 1. VEOZA SmPC §4.8 03.2025. 2. Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147–64.
Abbreviations NKB, neurokinin B; NK3R, neurokinin 3 receptor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.1 03.2025. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Jayasena CN, Comninos AN, Stefanopoulou E, Buckley A, Narayanaswamy S, Izzi-Engbeaya C, et al. Neurokinin B administration induces hot flushes in women. Sci Rep. 2015 Feb 16;5:8466.
Abbreviations VMS, vasomotor symptyoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489–501.
Sleep disturbance3-6
4,6
Reduced work productivity3,5,7
Reduced work productivity3,5,7
- A study found that women with untreated VMS had 57% more indirect work productivity loss days than controls.7
Job strain and high work demands are linked to more sleep disturbances. In turn, poor sleep quality can reduce work productivity and overall quality of life.6 Furthermore, women with inadequate sleep related to VMS report being slower, struggling with tasks, and feeling tired during the day, which may also affect work productivity5 — click on each to learn more.VMS
Abbreviations QoL, quality of life; VMS, vasomotor symptoms. References 1. Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199–215. 2. Williams RE, Levine KB, Kalilani L, Lewis J, Clark RV. Menopause-specific questionnaire assessment in US population-based study shows negative impact on health-related quality of life. Maturitas. 2009 Feb 20;62(2):153–9. 3. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 4. Kronenberg F. Menopausal hot flashes: a review of physiology and biosociocultural perspective on methods of assessment. J Nutr. 2010 Jul;140(7):1380S–5S. 5. Gombert-Labedens M, Vesterdorf K, Fuller A, Maloney SK, Baker FC. Effects of menopause on temperature regulation. Temperature. 2025 Apr 3;12(2):92–132.
NOT CORRECT!
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -6.94 [(SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].5
See more in next slides
VEOZA reduced the average daily frequency of hot flushes and night sweats by 63%.
~2 out of 7 episodes
Abbreviations VMS, vasomotor symptoms. References 1. VEOZA SmPC §4.2 03.2025. 2. VEOZA SmPC §3 03.2025. 3. VEOZA SmPC §4.1 03.2025.
NOT CORRECT!
Blocking NKB-mediated activation of KNDy neurons restores normal KNDy activity, reducing overstimulation of thermoregulatory pathways, targeting the source of VMS to reduce their frequency and severity.1-3
Learn more in the section: Mechanism of VMS.
Because it enhances serotonin activity, stabilising temperature regulation
Abbreviations LS, least squares; SE, standard error; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 4. VEOZA SmPC §4.1 03.2025.
Vasomotor symptoms
Vasomotor symptoms (VMS)5
VMS are commonly known as hot flushes and night sweats:
Hot flushes: Episodes of sudden intense sensation of heat, lasting 1 to 5 minutes, and typically starting in the face, neck, or chest and spreading across the torso, with frequency ranging from a few per week to multiple times per day.
Night sweats: Hot flushes that occur at night, normally during sleep.
NOT CORRECT!
VMS are very common, affecting up to 80% of women during the menopausal transition.1,2
Learn more in the section: Life with VMS.
Every woman experiences VMS
Abbreviations BMI, body mass index; CYP1A2, cytochrome P450 1A2; PROMIS SD SF, Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
NOT CORRECT!
VEOZA reduced VMS severity from moderate-severe to mild-moderate at Week 12.
Based on pooled results from SKYLIGHT 1 & 2, the reduction was -0.67 [(SE 0.04) from baseline (2.40; SD 0.35)] vs -0.42 for the placebo group [(SE 0.04) from baseline (2.42; SD 0.34)].3
VEOZA shifted VMS severity from moderate-severe to moderate
See more in next slides
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.3,4 §LESS DISTURBED SLEEP: The pooled analysis from SKYLIGHT 1 and 2 showed a greater decrease in patient-reported sleep disturbances at Week 12 with VEOZA vs placebo (-4.8 and -3.3 from baseline, respectively; treatment difference: -1.5 [95% CI: -2.5, -0.5]).5 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; OTC, over-the-counter; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.4,5 §SIGNIFICANT EFFECT FROM WEEK 4: The pooled results from SKYLIGHT 1 and 2 demonstrated a clinically meaningful decrease from baseline at Week 4 compared to placebo (reduction of 2 or more VMS episodes per 24h; p<0.001). At Week 4, patients experienced a 52.84% reduction in the average daily frequency of hot flushes and night sweats in the VEOZA group [-5.79 (SE 0.23) from baseline 11.10 (SD 6.45)] compared to a 31.96% reduction in the placebo group [-3.51 (SE 0.22) from baseline 11.04 (SD 4.46)].2 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; MHT, menopausal hormone therapy; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; VMS, vasomotor symptoms. References 1. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 2. VEOZA SmPC §5.1 03.2025. 3. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 5. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97.
Sexual function1
Decreased sexual desire
Dyspareunia (painful intercourse)
Sexual function
WEEK 12
Switched to VEOZA 45 mg
Placebo participants switched to VEOZA
AT WEEK 12
Following the 12-week placebo-controlled treatment period, patients were enrolled in an extension period. Those initially taking a placebo were switched to VEOZA, while patients who were initiated on VEOZA continued their treatment.1,2 Mean change in moderate to severe VMS data frequency was collected each week for an additional 40 weeks. The data during the extension period were summarised descriptively, with no inferential testing, due to the absence of a placebo control.1,2
Footnotes ‡FEWER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction in VMS frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in the average daily frequency of hot flushes and night sweats at Week 12 was 63% in the VEOZA group [-6.94 (SE 0.25) from baseline 11.10 (SD 6.45)] vs a 40% reduction in the placebo group [-4.43 (SE 0.25) from baseline 11.04 (SD 4.46)].1 §MILDER EPISODES: Pooled data from SKYLIGHT 1 and 2 showed a statistically significant reduction VMS severity from baseline to Weeks 4 and 12 compared to placebo (p<0.001). The reduction in average severity per day in women’s remaining VMS episodes was -0.67 (SE 0.04) from baseline (2.40; SD 0.35). For placebo, the reduction was -0.42 (SE 0.04) from baseline (2.42; SD 0.34).1 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; NK3R, neurokinin 3 receptor; SD, standard deviation; SE, standard error; SSRI, selective serotonin reuptake inhibitor; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 4. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102.
Study design2,3,*
Fezolinetant 30 mg
Placebo
Fezolinetant 45 mg
Visit:End of treatment
Randomisation 1:1:1 n=1,022
Visit:Follow-up
Screening
Fezolinetant 30 mg
Fezolinetant 30 mg
Fezolinetant 45 mg
Fezolinetant 45 mg
DAY 1
WEEK 4
WEEK 12
40-WEEK EXTENSION
WEEK 52
WEEK 55
Figure adapted from references 2 and 3. *The study design includes 30 mg arms to be consistent with SKYLIGHT 1 and SKYLIGHT 2. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to the 45 mg dose.
Abbreviations QoL, quality of life; VMS, vasomotor symptoms. References 1. Zhu D, Chung HF, Dobson AJ, Pandeya N, Giles GG, Bruinsma F, et al. Age at natural menopause and risk of incident cardiovascular disease: a pooled analysis of individual patient data. Lancet Public Health. 2019 Nov 1;4(11):e553–64. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Malmberg C, Althin R, Olofsson S. Productivity loss related to vasomotor symptoms (VMS) during menopausal transition among women in the Nordics. IHE-The Swedish Institute for Health Economics; 2024. 4. Davis SR, Pinkerton J, Santoro N, Simoncini T. Menopause-Biology, consequences, supportive care, and therapeutic options. Cell. 2023 Sep 14;186(19):4038–58. 5. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 6. POPU01: Population 1 January by unit, reporting country, age, sex and time [Internet]. [Cited 2025 Jul 18]. Available from: https://pxweb.nordicstatistics.org/pxweb/en/Nordic%20Statistics/Nordic%20Statistics__Demography__Population%20size/POPU01.px/?rxid=4bd7ba15-3c4a-4793-8711-6db1fc878223
Abbreviations CI, confidence interval; LS, least squares; MMRM, mixed-model for repeated measures; PGI-C SD, Patient Global Impression of Change in Sleep Disturbance; PROMIS SD SF, Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form Questionnaire; VMS, vasomotor symptoms. References 1. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 2. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 3. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
POSTMENOPAUSE
Postmenopause is the lifelong stage following the final menstrual period.2 This stage is defined by:
Figure adapted from reference 4.
postmenopause
51 yr on average Final menstrual period
Study participants1-3
The studies consisted of postmenopausal women with a minimum average of 7 to 8 moderate to severe VMS per day or 50 to 60 per week within 10 days before randomisation:
*Baseline demographics also include women receiving fezolinetant 30 mg. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to the 45 mg dose.
Abbreviations MHT, menopausal hormone therapy; VMS, vasomotor symptoms. References 1. Meczekalski B, Kostrzak A, Unogu C, Bochynska S, Maciejewska-Jeske M, Bala G, et al. A New Hope for Woman with Vasomotor Symptoms: Neurokinin B Antagonists. J Clin Med. 2025 Feb 21;14(5):1438. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. VEOZA SmPC §4.1 03.2025.
Abbreviations CNS, central nervous system; CVD, cardiovascular disease; VMS, vasomotor symptoms. References 1. Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489–501. 2. Williams RE, Levine KB, Kalilani L, Lewis J, Clark RV. Menopause-specific questionnaire assessment in US population-based study shows negative impact on health-related quality of life. Maturitas. 2009 Feb 20;62(2):153–9. 3. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 4. Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005 Aug 5;3:47. 5. English M, Stoykova B, Slota C, Doward L, Siddiqui E, Crawford R, et al. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS sleep disturbance and sleep-related impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes. 2021 Apr 26;5(1):37. 6. Baker FC, Lampio L, Saaresranta T, Polo-Kantola P. Sleep and sleep disorders in the menopausal transition. Sleep Med Clin. 2018 Sep;13(3):443–56. 7. Sarrel P, Portman D, Lefebvre P, Lafeuille MH, Grittner AM, Fortier J, et al. Incremental direct and indirect costs of untreated vasomotor symptoms. Menopause. 2015 Mar;22(3):260–6. 8. Thurston RC, Carroll JE, Levine M, Chang Y, Crandall C, Manson JE, et al. Vasomotor Symptoms and Accelerated Epigenetic Aging in the Women's Health Initiative (WHI). J Clin Endocrinol Metab. 2020 Apr 1;105(4):1221–7. 9. Thurston RC, Maki PM, Derby CA, Sejdić E, Aizenstein HJ. Menopausal hot flashes and the default mode network. Fertil Steril. 2015 Jun;103(6):1572–8.e1. 10. Thurston RC, Aizenstein HJ, Derby CA, Sejdić E, Maki PM. Menopausal hot flashes and white matter hyperintensities. Menopause. 2016 Jan;23(1):27–32. 11. Thurston RC. Vasomotor symptoms: natural history, physiology, and links with cardiovascular health. Climacteric. 2018 Apr;21(2):96–100. 12. Thurston RC, Chang Y, Barinas-Mitchell E, Jennings JR, Landsittel DP, Santoro N, et al. Menopausal Hot Flashes and Carotid Intima Media Thickness Among Midlife Women. Stroke. 2016 Dec;47(12):2910–5. 13. Lett HS, Blumenthal JA, Babyak MA, Sherwood A, Strauman T, Robins C, et al. Depression as a risk factor for coronary artery disease: evidence, mechanisms, and treatment. Psychosom Med. 2004 May–Jun;66(3):305–15. 14. Cappuccio FP, Cooper D, D'Elia L, Strazzullo P, Miller MA. Sleep duration predicts cardiovascular outcomes: a systematic review and meta-analysis of prospective studies. Eur Heart J. 2011 Jun 1;32(12):1484–92. 15. Avis NE, Crawford S, Stellato R, Longcope C. Longitudinal study of hormone levels and depression among women transitioning through menopause. Climacteric. 2001 Jan 1;4(3):243–9.
Abbreviations HCPs, healthcare professionals; VMS, vasomotor symptoms. References 1. DePree B, Houghton K, Shiozawa A, Esterberg E, King DD, Kim J, et al. Treatment and resource utilization for menopausal symptoms in the United States: a retrospective review of real-world evidence from US electronic health records. Menopause. 2023 Jan 1;30(1):70–9. 2. Todorova L, Bonassi R, Guerrero Carreño FJ, Hirschberg AL, Yuksel N, Rea C, et al. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179–89. 3. Barber K, Charles A. Barriers to Accessing Effective Treatment and Support for Menopausal Symptoms: A Qualitative Study Capturing the Behaviours, Beliefs and Experiences of Key Stakeholders. Patient Prefer Adherence. 2023 Nov 15;17:2971–80. 4. Hirschberg AL, Polo‐Kantola P, Øverlie I, Løkkegaard E, Cockburn E, Rea C, et al. Prevalence and impact of vasomotor symptoms associated with menopause among Nordic women: Subgroup analysis from an international cross‐sectional survey. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1575–86. 5. Constantine GD, Graham S, Clerinx C, Bernick BA, Krassan M, Mirkin S, et al. Behaviours and attitudes influencing treatment decisions for menopausal symptoms in five European countries. Post Reprod Health. 2016 Sep;22(3):112–22. 6. Dintakurti N, Kalyanasundaram S, Jha P, Talaulikar V. An online survey and interview of GPs in the UK for assessing their satisfaction regarding the medical training curriculum and NICE guidelines for the management of menopause. Post Reprod Health. 2022 Sep;28(3):137–41.
Footnotes ‡LASTING EFFECT: The pooled results from SKYLIGHT 1 and 2 showed a statistical significant reduction in VMS mean daily frequency from baseline to Weeks 4 and 12 compared to placebo (p<0.001). In both SKYLIGHT 1 and 2, the reduction in VMS mean daily frequency achieved at Week 12 was maintained up to Week 52.3,4 §LESS DISTURBED SLEEP: The pooled analysis from SKYLIGHT 1 and 2 showed a greater decrease in patient-reported sleep disturbances at Week 12 with VEOZA vs placebo (-4.8 and -3.3 from baseline, respectively; treatment difference: -1.5 [95% CI: -2.5, -0.5]).5 Abbreviations KNDy, kisspeptin/neurokinin B/dynorphin; OTC, over-the-counter; VMS, vasomotor symptoms. References 1. VEOZA SmPC §5.1 03.2025. 2. Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin on Investig Drugs. 2021 Jul 3;30(7):681–94. 3. Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091–102. 4. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, et al Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981–97. 5. Shapiro CMM, Cano A, Nappi RE, Santoro N, English ML, Mancuso S, et al. Effect of fezolinetant on sleep disturbance and impairment during treatment of vasomotor symptoms due to menopause. Maturitas. 2024 Aug;186:107999.
Abbreviations ALP, alkaline phosphatase; COVID-19, coronavirus disease 2019; CPK, creatine phosphokinase; TEAE, treatment emergent adverse event. References 1. VEOZA SmPC §4.8 03.2025. 2. Kagan R, Cano A, Nappi RE, English ML, Mancuso S, Wu X, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2025 Feb;42(2):1147–64.
Abbreviations ALT, alanine aminotransferase; AST, aspartate aminotransferase; MedRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event; SOC, system organ class. References 1. VEOZA SmPC §4.8 03.2025.
Urogenital system1
Vaginal dryness
Vulvar itching and burning
Dysuria (painful urination)
Urinary frequency and urgency
Recurrent lower urinary tract infections
Urogenital system
Participants in the study:1
*Baseline demographics also include women receiving fezolinetant 30 mg. However, since 45 mg is the only approved dose, efficacy and safety data shown will be limited to the 45 mg dose
Skin, mucosa, & hair
Skin, mucosa, & hair1
Reduced skin thickness
Reduced elasticity
Reduced skin hydration
Increased wrinkling
Hair loss