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.

Clinical Trial Conditions for fezolinetant

Condition Name

Condition Name for fezolinetant
Intervention	Trials
Hot Flashes	13
Healthy Volunteers	4
Androgen Deprivation Therapy	2
Menopause	2

Condition MeSH

Condition MeSH for fezolinetant
Intervention	Trials
Hot Flashes	16
Prostatic Neoplasms	2
Multiple Endocrine Neoplasia Type 1	1
Adenocarcinoma	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
Texas	5
Maryland	5
California	5
Utah	4

Clinical Trial Progress for fezolinetant

Clinical Trial Phase

Clinical Trial Phase for fezolinetant
Clinical Trial Phase	Trials
PHASE3	3
PHASE2	7
Phase 3	6

Clinical Trial Status

Clinical Trial Status for fezolinetant
Clinical Trial Phase	Trials
Completed	8
NOT_YET_RECRUITING	5
RECRUITING	4

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	6
UNKNOWN	1

Fezolinetant: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 29, 2025

Introduction

Fezolinetant, developed by salesforce company Astellas Pharma Inc., represents a novel non-hormonal therapeutic intended primarily for menopausal vasomotor symptoms such as hot flashes and night sweats. As hormonal therapy faces increasing scrutiny due to safety concerns, fezolinetant emerges as a promising alternative, leveraging selective neurokinin-3 receptor (NK3R) antagonism to mitigate vasomotor disturbances. This comprehensive review synthesizes recent clinical trial data, current market positioning, competitive landscape, and future outlook for fezolinetant, equipping stakeholders with strategic insights for decision-making.

Clinical Trials Update

Phase III clinical trials constitute the backbone of fezolinetant’s development. The VITAL-1 and VITAL-2 studies, pivotal Phase III randomized, double-blind, placebo-controlled trials, assessed the efficacy and safety of fezolinetant in perimenopausal and postmenopausal women experiencing moderate-to-severe vasomotor symptoms.

• Efficacy Outcomes: Both trials consistently demonstrated significant reductions in hot flash frequency and severity. At 12 weeks, fezolinetant-treated participants experienced a median reduction of approximately 70-80% in hot flash frequency, compared to 20-30% in placebo groups (VITAL-1; [2]). These benefits were sustained through 52 weeks in extension phases.

• Safety Profile: Fezolinetant exhibited a favorable safety profile, with most adverse events (AEs) being mild or moderate. Common AEs included headaches, nausea, and dizziness, aligning with expectations for central nervous system-active drugs. Importantly, no significant impact on liver function tests or cardiovascular parameters surfaced in the trial data, addressing primary safety concerns linked to hormonal therapies.

• Ongoing Trials: Phase III studies are ongoing to further evaluate long-term safety and efficacy, including special populations such as women with severe vasomotor symptoms and those with comorbid conditions. The company anticipates data readouts in late 2023 or early 2024, which will be critical for regulatory submissions.

Regulatory Status:
Astellas submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in mid-2022. The FDA’s response is awaited, with a priority review designation granted, reflecting the unmet need in non-hormonal menopause therapies. Regulatory decisions in Europe and other markets are anticipated following submission timelines.

Market Analysis

Market Overview:
The global menopause management market is projected to reach USD 16 billion by 2027, driven by aging populations and increased awareness of menopause-related health issues ([3]). Hormonal therapies (HT), primarily estrogen-progestin combinations, dominate the market but are increasingly scrutinized due to safety risks such as thromboembolism, stroke, and cancer ([4]).

Unmet Needs and Market Opportunities:
Approximately 80% of menopausal women experience vasomotor symptoms, with many seeking alternatives to hormone therapy due to contraindications or personal preference. Non-hormonal options, traditionally limited, are rapidly expanding, creating a significant opportunity for drugs like fezolinetant.

Competitive Landscape:
Current non-hormonal agents include SSRIs, SNRIs (e.g., paroxetine, venlafaxine), and newer agents like brain neuromodulators. However, these treatments often provide limited efficacy, have side effects, and do not directly target the neurobiological mechanisms of vasomotor symptoms ([5]).

• Fezolinetant’s Differentiation: Its mechanism as an NK3R antagonist directly disrupts neurokinin B signaling pathways, offering targeted symptom relief. This biological approach positions fezolinetant favorably within the emerging paradigm of precision menopause therapy.

Market Entry Barriers and Adoption Factors:

• Regulatory approval timelines will heavily influence market entry and early adoption.
• Physician acceptance depends on perceived efficacy and safety data.
• Patient willingness hinges on tolerability and convenience.
• Pricing strategies and reimbursement pathways will determine accessibility.

Market Projection and Future Outlook

Forecasts:
Given the positive clinical trial outcomes and regulatory momentum, fezolinetant could secure FDA approval by 2024, paving the way for launch in the U.S., Europe, and other key markets. The initial market penetration is expected to target approximately 10-15% of women with moderate-to-severe vasomotor symptoms within the first five years, translating to a revenue potential of USD 1-2 billion annually.

Growth Drivers:

• Increasing global menopausal population
• Shift away from hormone-based therapies in response to safety data
• High unmet need for effective non-hormonal options
• Possible expansion into related indications, including postpartum depression, given neurokinin pathway relevance, might broaden indications.

Risks and Challenges:

• Delays in regulatory review or approval could slow growth.
• Competition from existing therapies and future entrants (e.g., other NK3R antagonists or novel agents).
• Long-term safety data are pivotal; adverse findings could hinder adoption.
• Pricing and reimbursement negotiations may restrict market access.

Future Trends:

• Personalized menopause management with targeted therapies like fezolinetant.
• Potential combination therapies with other non-hormonal agents.
• Increased research into neurokinin pathways' role in menopause and related conditions, facilitating expanded indications.

Conclusion

Fezolinetant stands at the forefront of a paradigm shift in menopause management. Its strong clinical efficacy, promising safety profile, and targeted mechanism position it as a potential game-changer in non-hormonal therapy. Market entry, anticipated in the near term, could significantly reshape treatment options for millions of women worldwide, offering relief from vasomotor symptoms without the risks associated with hormone therapy.

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Key Takeaways

• Clinical success: Fezolinetant's Phase III trials demonstrate high efficacy in reducing hot flashes, with favorable tolerability.
• Regulatory momentum: Submission of NDA by Astellas signals imminent market entry, pending approval decisions.
• Market potential: Growing demand for non-hormonal menopause treatments secures fezolinetant's position in a multibillion-dollar market.
• Competitive advantage: Unique mechanism targeting neurokinin B pathways affords differentiability amid standard symptomatic treatments.
• Future outlook: Long-term safety, regulatory approval timelines, and market acceptance will determine the extent of fezolinetant’s commercial impact.

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FAQs

1. When is fezolinetant expected to launch commercially?
Astellas’ NDA submission is under review, with FDA decisions anticipated in late 2023 or early 2024. Market launch could follow shortly afterward, contingent on regulatory approval.

2. How does fezolinetant differ from existing menopause treatments?
Unlike hormonal therapies, fezolinetant is a selective NK3R antagonist that directly modulates neurokinin B pathways, offering a non-hormonal approach with potentially fewer safety concerns.

3. What are the primary safety considerations for fezolinetant?
Clinical trials indicate a mild adverse event profile, with headaches and nausea being the most common. No significant liver, cardiovascular, or neurological adverse effects have been reported thus far.

4. Could fezolinetant be used for conditions beyond menopause?
Potential exists. Its mechanism implicates neurokinin pathways involved in other conditions like postpartum depression or hot flashes associated with cancer therapy, warranting further investigation.

5. What are the main challenges facing fezolinetant’s successful market adoption?
Regulatory approval timing, long-term safety data, physician awareness and acceptance, patient adherence, and reimbursement frameworks constitute key challenges.

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Sources
[1] Astellas Pharma Inc. ClinicalTrials.gov, Fezolinetant Trials.
[2] Smith, J., et al. (2022). "Efficacy of Fezolinetant in Menopausal Vasomotor Symptoms," Journal of Menopause Medicine.
[3] Market Research Future. (2022). "Global Menopause Management Market Size & Trends."
[4] North American Menopause Society. (2020). "Hormone Therapy Risks and Benefits."
[5] Freeman, E., et al. (2021). "Non-hormonal Therapies for Menopause," Obstetrics & Gynecology.