Want to create interactive content? It’s easy in Genially!

Get started free

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:

Vision Board

Periodic Table

SWOT Challenge: Classify Key Factors

Explainer Video: Keys to Effective Communication

Explainer Video: AI for Companies

Corporate CV

Flow Presentation

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)
  • 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
  • Sensation of heat

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

  • Mean age of ~55 years*
  • 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