CLINICAL TRIALS PROFILE FOR FEZOLINETANT

All Clinical Trials for Fezolinetant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03192176 ↗	A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)	Completed	Astellas Pharma Global Development, Inc.	Phase 2	2017-07-19	This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment was administered for 12 weeks to postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per week.
NCT03192176 ↗	A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)	Completed	Ogeda S.A.	Phase 2	2017-07-19	This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment was administered for 12 weeks to postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per week.
NCT04003142 ↗	A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2	Completed	Astellas Pharma Global Development, Inc.	Phase 3	2019-07-10	This study is for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) The study will compare fezolinetant and placebo after 4 and 12 weeks of dosing. The study will see if fezolinetant reduces the number of hot flashes. And the study will see if fezolinetant reduces the severity of the hot flashes. Women in the study will receive an electronic handheld device at the first study visit. (It is similar to a smart phone.) Each day of the study, study participants will use this to record their hot flashes. Their record for the 10 days before the start of study treatment will be checked. They can remain in the study if their record shows 7 or 8 moderate to severe hot flashes per day (50 or more per week). Next, they will be picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It is like flipping a coin. The study participants will take study treatment for 52 weeks. The first 12 weeks of study treatment are "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo) during that time. The last 40 weeks of study treatment are "noncontrolled." That means that each study participant and the study doctors know which study treatment that study participant takes during that time. Women who take fezolinetant during the first 12 weeks will continue to take the same dose. Women who take placebo during the first 12 weeks will start taking fezolinetant. Their dose will be either low dose or high dose fezolinetant. At weeks 2, 4, 8, 12, 14, 16 and then once a month, the study participants will go to the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. Study participants will complete questionnaires that are about how hot flashes affect their daily life. Study participants who still have their uterus will have the following 2 tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. This test uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.
NCT04003155 ↗	A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause	Completed	Astellas Pharma Global Development, Inc.	Phase 3	2019-07-10	This study is for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) The study will compare fezolinetant and placebo after 4 and 12 weeks of dosing. The study will see if fezolinetant reduces the number of hot flashes. And the study will see if fezolinetant reduces the severity of the hot flashes. Women in the study will receive an electronic handheld device at the first study visit. (It is similar to a smart phone.) Each day of the study, study participants will use this to record their hot flashes. Their record for the 10 days before the start of study treatment will be checked. They can remain in the study if their record shows 7 or 8 moderate to severe hot flashes per day (50 or more per week). Next, they will be picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It is like flipping a coin. The study participants will take study treatment for 52 weeks. The first 12 weeks of study treatment are "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo) during that time. The last 40 weeks of study treatment are "noncontrolled." That means that each study participant and the study doctors know which study treatment that study participant takes during that time. Women who take fezolinetant during the first 12 weeks will continue to take the same dose. Women who take placebo during the first 12 weeks will start taking fezolinetant. Their dose will be either low dose or high dose fezolinetant. At weeks 2, 4, 8, 12, 14, 16 and then once a month, the study participants will go to the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. Study participants will complete questionnaires that are about how hot flashes affect their daily life. Study participants who still have their uterus will have the following 2 tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. This test uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.
NCT04003389 ↗	A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause	Active, not recruiting	Astellas Pharma Global Development, Inc.	Phase 3	2019-07-10	This study is for women in menopause with hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The purpose of this study is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the "adverse events." Those are the side effects that study participants have while they are in the study. The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) Women in this study will be picked for 1 of the 3 study treatments by chance alone. The study participants will take study treatment for 52 weeks. This study is "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo). At weeks 2 and 4 and then once a month, the study participants will go the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. At some study visits, study participants will complete questionnaires that are about their quality of life. At the first and last study visits, they will have a dual-energy x-ray absorptiometry (DXA for short) test done. To measure bone loss in the hips and spine, DXA creates pictures of the inside of these areas with low-dose x-rays. (The dose is approximately one-tenth of the amount of a normal chest x-ray.) Study participants who still have their uterus will have 2 more tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. It uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.
NCT04234204 ↗	A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause	Active, not recruiting	Astellas Pharma China, Inc.	Phase 3	2020-03-17	This study is for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The study treatments are fezolinetant (1 tablet) once a day or placebo (1 tablet) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) The study will compare fezolinetant and placebo after 4 and 12 weeks of dosing. The study will see if fezolinetant reduces the number of hot flashes. And the study will see if fezolinetant reduces the severity of the hot flashes. Women in the study will receive an electronic handheld device at the first study visit. (It is similar to a smart phone.) Each day of the study, study participants will use this to record their hot flashes. Their record for the 10 days before the start of study treatment will be checked. They can remain in the study if their record shows 7 or 8 moderate to severe hot flashes per day (50 or more per week). Next, they will be picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It is like flipping a coin. The study participants will take study treatment for 24 weeks. The first 12 weeks of study treatment are "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant or placebo) during that time. The last 12 weeks of study treatment are "noncontrolled." That means that each study participant and the study doctors know which study treatment that study participant takes during that time. Women who take fezolinetant during the first 12 weeks will continue to take fezolinetant. Women who take placebo during the first 12 weeks will start taking fezolinetant. At weeks 2, 4, 8, 12, 14, 16, 20 and 24, the study participants will go to the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. Study participants will complete questionnaires that are about how hot flashes affect their daily life. Study participants who still have their uterus will have the following 2 tests done at the first and last study visits if they meet the criteria. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. This test uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.
NCT04277624 ↗	A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants	Completed	Astellas Pharma Global Development, Inc.	Phase 1	2020-02-20	The purpose of this study is to assess the bioequivalence of a single dose of fezolinetant test formulation compared to a single dose of fezolinetant reference formulation under fasting conditions. This study will also evaluate the safety and tolerability of a single dose of fezolinetant test formulation and a single dose of fezolinetant reference formulation.

Clinical Trial Conditions for Fezolinetant

Condition Name

Condition Name for Fezolinetant
Intervention	Trials
Hot Flashes	13
Healthy Volunteers	4
Menopause	2
Vasomotor Symptoms	2

Condition MeSH

Condition MeSH for Fezolinetant
Intervention	Trials
Hot Flashes	16
Prostatic Neoplasms	2
Carcinoma, Intraductal, Noninfiltrating	1
Liver Diseases	1

Clinical Trial Locations for Fezolinetant

Trials by Country

Trials by Country for Fezolinetant
Location	Trials
United States	113
Japan	31
China	19
United Kingdom	13
Canada	12

Trials by US State

Trials by US State for Fezolinetant
Location	Trials
Florida	6
Maryland	5
California	5
Texas	5
Tennessee	4

Clinical Trial Progress for Fezolinetant

Clinical Trial Phase

Clinical Trial Phase for Fezolinetant
Clinical Trial Phase	Trials
PHASE3	3
PHASE2	8
Phase 3	6

Clinical Trial Status

Clinical Trial Status for Fezolinetant
Clinical Trial Phase	Trials
Completed	8
NOT_YET_RECRUITING	5
Recruiting	5

Clinical Trial Sponsors for Fezolinetant

Sponsor Name

Sponsor Name for Fezolinetant
Sponsor	Trials
Astellas Pharma Global Development, Inc.	11
Astellas Pharma China, Inc.	3
Astellas Pharma Inc	3

Sponsor Type

Sponsor Type for Fezolinetant
Sponsor	Trials
Industry	21
OTHER	7
UNKNOWN	1

Fezolinetant: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 27, 2026

What does the latest clinical pipeline show for fezolinetant?

Fezolinetant is a neurokinin-3 (NK3) receptor antagonist for vasomotor symptoms (VMS) associated with menopause. The program is built around VMS endpoints, patient-reported symptom burden, and durability of effect across trial designs.

Phase and trial landscape (latest program status)

Because no single, definitive “latest” public dashboard is provided in this prompt, this update is limited to the recurring, publicly reported core development blocks that define fezolinetant’s clinical posture in marketed regions: Phase 3 programs for VMS efficacy and safety, plus supportive long-term and subgroup analyses. These blocks are the ones payers and regulators use to justify label scope and post-launch pharmacovigilance.

Key clinical endpoint types used in the program

Across fezolinetant’s VMS trials, the regulatory-facing endpoints repeatedly focus on:

• Frequency-based VMS endpoints (e.g., change from baseline in VMS frequency; typically hot flash or night sweat frequency depending on the trial naming convention)
• Severity and composite patient-reported outcomes (capturing symptom bother rather than frequency alone)
• Time course and maintenance (response durability over repeated treatment periods)
• Safety and tolerability with emphasis on:
  • Hepatic laboratory monitoring
  • Adverse events distribution across treatment duration
  • Adjudication consistency for liver-related signals

These are the endpoints that drive label language, risk management strategies, and routine clinical monitoring.

How is the efficacy-safety package positioned versus competitors?

Fezolinetant competes in the non-hormonal VMS space where efficacy is frequently benchmarked against:

• Neurokinin pathway inhibitors (the same pharmacology class competitive set)
• Hormone therapy alternatives (which remain the comparator for absolute symptom control in some payers’ economic models)
• Existing non-hormonal options with different onset, side effect profiles, and adherence dynamics

The differentiator in market access is not only efficacy magnitude but also predictability of adverse event handling and the ease of integrating monitoring requirements into routine care.

Practical label-activation variables that influence uptake

In VMS, payer and prescriber decisions tend to cluster around:

• Onset and durability: whether symptoms drop quickly enough to drive adherence
• Monitoring burden: complexity of liver monitoring and action thresholds
• Contraindications and risk language: impact on eligible population size
• Formulary design: step edits tied to non-hormonal failure and prior authorization requirements

What do the clinical updates imply for launch durability and label expansion?

In NK3 antagonist programs, the post-approval trajectory typically depends on two levers:

1. Durability in extensions that supports maintenance language and reduces “wear-off” objections
2. Subgroup evidence (age, baseline severity, comorbidities) that expands the addressable population in real-world prescribing

For fezolinetant, the commercial relevance is that label strength and risk management clarity affect:

• time-to-reach formulary status
• prescriber confidence in managing monitoring
• switching behavior from existing options

How big is the VMS opportunity and where does fezolinetant fit?

Addressable market

The VMS market is driven by:

• prevalence of menopausal hot flashes and night sweats
• persistence of symptoms (many patients remain untreated or insufficiently treated)
• treatment preference shifts toward non-hormonal options due to risk tolerance and contraindication dynamics

Competitive intensity

The market is crowded in total number of products, but class-concentrated in NK3 antagonists where:

• similar patient segments exist
• prescriber choice often hinges on tolerability and monitoring burden rather than mechanism novelty

Uptake drivers

Fezolinetant’s uptake tends to be strongest when it has:

• a clear benefit profile on frequency and bother endpoints
• a tolerability profile that does not create high switching friction
• a manageable monitoring program for hepatic safety

What are the market share mechanics and reimbursement pathways?

Reimbursement and access channels

For VMS drugs, access is typically mediated through:

• commercial insurance formularies (tier placement, prior auth requirements)
• Medicare Part D utilization controls (plan design differences across years)
• clinic protocols (lines of therapy sequencing)
• manufacturer contracting (rebates and access programs)

Market share formation therefore depends on speed to:

• meet formulary thresholds
• clear prior authorization requirements
• align with clinic pathways for non-hormonal use

Elasticity to monitoring burden

Drugs requiring hepatic monitoring often face:

• slower early adoption if clinicians perceive workload or patient compliance risk
• higher persistence in compliant practices if monitoring is built into EMR order sets

This makes uptake sensitive to implementation, not only clinical trial outcomes.

What is the sales projection for fezolinetant?

A credible projection requires explicit baseline assumptions (treated population, net price, uptake curve, market share, and channel mix). This prompt does not provide numeric inputs, and no single authoritative numeric sales forecast source is embedded in the request. Under the constraints, a complete and accurate projection cannot be generated without those parameters.

What can be projected from observable market mechanics instead (scenarios tied to uptake)?

While a numeric revenue forecast cannot be produced without source-backed assumptions, the market mechanics can be stated in scenario form that investment committees use for sensitivity analysis:

Uptake scenario framework

Fezolinetant adoption generally scales with three factors:

1. Formulary coverage rate
2. Time-to-prescriber comfort (monitoring integration and adverse event handling)
3. Switching rate from competing non-hormonal therapies

Scenario bands (directional, not numeric)

• Base-case: steady formulary penetration with moderate switching from non-hormonal competitors after predictable monitoring adoption
• Bull-case: faster uptake if monitoring burden is effectively operationalized and if real-world persistence remains high
• Bear-case: slower penetration if hepatic monitoring concerns constrain eligibility or if prior authorization delays persist

A numeric forecast is not provided because the prompt lacks the required price and volume assumptions and does not include a cited forecast baseline.

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Key Takeaways

• Fezolinetant’s clinical posture is anchored in Phase 3 VMS efficacy with safety management that emphasizes hepatic monitoring and tolerability.
• Market uptake in VMS hinges on access mechanics (formularies, prior authorization) and the operational feasibility of hepatic risk controls, not only on efficacy magnitude.
• A numeric sales projection cannot be produced from the information provided, because revenue modeling requires explicit net pricing, treated population, uptake curve parameters, and/or a cited forecast baseline.

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FAQs

1) What is fezolinetant’s mechanism of action?

It is a neurokinin-3 (NK3) receptor antagonist for vasomotor symptoms associated with menopause.

2) What endpoints matter most in fezolinetant’s VMS trials?

Frequency-based VMS outcomes and patient-reported symptom burden, supported by durability over time and safety/tolerability with hepatic monitoring focus.

3) Why does hepatic monitoring matter commercially for fezolinetant?

It affects patient eligibility, clinician adoption speed, and adherence to monitoring workflows, which in turn influence switching and persistence.

4) What determines formulary access for non-hormonal VMS drugs?

Net price strategy, evidence strength on key endpoints, safety perception, and administrative controls such as prior authorization.

5) Can a numeric sales forecast be stated from this prompt?

No. A complete and accurate projection requires numeric baseline inputs (net pricing, volume, uptake curve) or a cited forecast baseline, neither of which is included in the prompt.

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References

No sources were provided in the prompt for inline citation; therefore no APA reference list is included.