About this data
Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.
Fezolinetant
- Company
- University of Colorado, Denver
- Mechanism
- Mechanism not yet reported
- Route
- Route not yet reported
- Recruiting trials
- 8 recruiting
Efficacy results: Not yet reported
8 recruiting studies currently listed on ClinicalTrials.gov.
Data source: ClinicalTrials.gov · trial data as of Nov 4, 2026
Find a Clinical Trial Near Me
See recruiting studies for Fezolinetant and check eligibility with the study team.
Trial details
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Recruiting NCT NCT06917313
FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
Not yet reported Yale University 92 participants Est. completion 2028-03 2 sitesOther conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)View official trial listing → -
Recruiting NCT NCT06957691
Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy
Not yet reported Shehzad Basaria, M.D. 60 participants Est. completion 2028-12-31 1 site Stand-aloneOther conditions: Prostate Cancer, Prostate Cancer (Adenocarcinoma), Prostate Cancer Metastatic Disease, Prostate Cancer Recurrent, Prostate Carcinoma, Prostate Neoplasm, Prostate Adenocarcinoma, Prostate Cancer With Bone Metastasis, Vasomotor Disturbance, Vasomotor Symptoms, Vasomotor Symptoms (VMS), Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Vasomotor Symptoms; Hot Flashes, Androgen Deprivation Therapy, Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma, Androgen-deprivation Therapy, Hot Flashes, Hot Flushes, Hot Flushes and/or SweatsView official trial listing → -
Recruiting NCT NCT06972875
Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer
Not yet reported University of Vermont 32 participants Est. completion 2027-02 1 site Stand-aloneOther conditions: Prostate CA, Androgen Deprivation TherapyView official trial listing → -
Recruiting NCT NCT06975111
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Not yet reported, Not yet reported University of Colorado, Denver 200 participants Est. completion 2030-10-01 3 sites Stand-aloneOther conditions: Menopause, Menopause Hot Flashes, Menopause Related Conditions, CardiovascularView official trial listing → -
Recruiting NCT NCT07568236
A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)
Not yet reported Chinese University of Hong Kong 54 participants Est. completion 2028-03-31 1 site Stand-aloneOther conditions: Vasomotor Symptoms, Prostate CancerView official trial listing → -
Recruiting NCT NCT07602530
A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice
Astellas Pharma Europe Ltd. 238 participants Est. completion 2027-11-30 2 sitesOther conditions: Hot FlashesView official trial listing → -
Recruiting NCT NCT07783282
A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer
Not yet reported Astellas Pharma Global Development, Inc. 56 participants Est. completion 2027-04-30 1 site Stand-aloneOther conditions: Prostate CancerView official trial listing → -
Recruiting NCT NCT07829653
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Not yet reported Astellas Pharma Inc 100 participants Est. completion 2028-04-30 1 site Stand-aloneOther conditions: Hot FlashesView official trial listing → -
Completed NCT NCT03192176
A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)
Not yet reported Astellas Pharma Global Development, Inc. 356 participants Est. completion 2018-09-19 51 sites Stand-aloneOther conditions: Menopause, Hot FlashesView official trial listing → -
Completed NCT NCT03436849
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects
Not yet reported Astellas Pharma Inc 44 participants Est. completion 2018-05-23 1 siteOther conditions: Healthy SubjectsView official trial listing → -
Completed NCT NCT04003142
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2
Not yet reported Astellas Pharma Global Development, Inc. 501 participants Est. completion 2021-04-23 93 sites Stand-aloneOther conditions: Hot FlashesView official trial listing → -
Completed NCT NCT04003155
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause
Not yet reported Astellas Pharma Global Development, Inc. 527 participants Est. completion 2021-08-11 96 sites Stand-aloneOther conditions: Hot FlashesView official trial listing → -
Completed NCT NCT04003389
A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause
Not yet reported Astellas Pharma Global Development, Inc. 1831 participants Est. completion 2022-01-04 182 sites Stand-aloneOther conditions: Hot FlashesView official trial listing → -
Completed NCT NCT04234204
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause
Not yet reported Astellas Pharma China, Inc. 302 participants Est. completion 2022-04-20 48 sites Stand-aloneOther conditions: Hot FlashesView official trial listing → -
Completed NCT NCT04277624
A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants
Not yet reported Astellas Pharma Global Development, Inc. 22 participants Est. completion 2021-02-26 1 site Stand-aloneOther conditions: Healthy VolunteersView official trial listing → -
Completed NCT NCT04451226
A Study to Assess the Safety and Tolerability of Fezolinetant in Women Seeking Treatment for Relief of Vasomotor Symptoms (VMS) Associated With Menopause
Not yet reported Astellas Pharma China, Inc. 150 participants Est. completion 2022-06-13 29 sites Stand-aloneOther conditions: Hot FlashesView official trial listing → -
Completed NCT NCT04476849
A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function
Not yet reported Astellas Pharma Global Development, Inc. 27 participants Est. completion 2022-03-11 7 sites Stand-aloneOther conditions: Healthy Volunteers, Renal ImpairmentView official trial listing → -
Completed NCT NCT04482270
A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function
Not yet reported Astellas Pharma Global Development, Inc. 26 participants Est. completion 2021-03-22 4 sites Stand-aloneOther conditions: Hepatic Impairment, Healthy VolunteersView official trial listing → -
Completed NCT NCT04641260
A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants
Not yet reported Astellas Pharma Global Development, Inc. 16 participants Est. completion 2021-02-21 1 site Stand-aloneOther conditions: Healthy SubjectsView official trial listing → -
Completed NCT NCT04793204
A Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects
Not yet reported Astellas Pharma China, Inc. 16 participants Est. completion 2021-05-21 1 site Stand-aloneOther conditions: Healthy VolunteersView official trial listing → -
Completed NCT NCT05033886
A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
Not yet reported Astellas Pharma Global Development, Inc. 453 participants Est. completion 2023-04-20 69 sites Stand-aloneOther conditions: Vasomotor SymptomsView official trial listing → -
Completed NCT NCT05034042
A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
Not yet reported Astellas Pharma Inc 147 participants Est. completion 2022-12-23 40 sites Stand-aloneOther conditions: Hot FlashesView official trial listing → -
Completed NCT NCT05419908
Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
Not yet reported Ogeda S.A. 87 participants Est. completion 2016-10-06 8 sites Stand-aloneOther conditions: Hot FlashesView official trial listing → -
Completed NCT NCT06049797
A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
Astellas Pharma Global Development, Inc. 999 participants Est. completion 2026-05-07 48 sitesOther conditions: Hot FlashesView official trial listing → -
Completed NCT NCT06206408
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through Menopause
Not yet reported Astellas Pharma Inc 410 participants Est. completion 2025-12-18 64 sites Stand-aloneOther conditions: Hot FlashesView official trial listing → -
Completed NCT NCT06206421
A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause
Not yet reported Astellas Pharma Inc 277 participants Est. completion 2026-03-19 24 sites Stand-aloneOther conditions: Hot FlashesView official trial listing → -
Active, not recruiting NCT NCT06440967
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
Not yet reported Astellas Pharma Global Development, Inc. 982 participants Est. completion 2028-04-30 110 sites Stand-aloneOther conditions: Hot FlashesView official trial listing → -
Terminated NCT NCT06617455
Fezolinetant for the Improvement of Vasomotor Symptoms in Breast Cancer Patients Taking Endocrine Therapy, VENT Trial
Not yet reported University of Michigan Rogel Cancer Center 9 participants Est. completion 2025-11-21 1 site Stand-aloneOther conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Ductal Carcinoma In Situ, Localized Breast CarcinomaView official trial listing → -
Completed NCT NCT06812754
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause
Not yet reported Astellas Pharma Global Development, Inc. 150 participants Est. completion 2026-03-05 26 sites Stand-aloneOther conditions: Hot FlashesView official trial listing → -
Completed NCT NCT07455812
A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause
Astellas Pharma Europe Ltd. 105 participants Est. completion 2026-07-16 1 siteOther conditions: Hot FlashesView official trial listing → -
Not yet recruiting NCT NCT07606664
Fezolinetant and Vascular Health and Brain Health
Not yet reported Rebecca Thurston 220 participants Est. completion 2029-12-30 2 sites Stand-aloneOther conditions: Menopause Hot FlashesView official trial listing → -
Not yet recruiting NCT NCT07732452
Hormone thERapy Effects on BRAin-HEART Health During the Menopausal Transition
Not yet reported McGill University Health Centre/Research Institute of the McGill University Health Centre 100 participants Est. completion 2029-01Cardiovascular disease Other conditions: Menopause, Perimenopause, Vasomotor Symptoms, Menopausal Hormone Therapy, Cardiac Remodeling, Myocardial Fibrosis, Microvascular Dysfunction, Cognitive Function AssessmentView official trial listing →
Efficacy history
Not yet reported.
Safety
Not yet reported.
Sources
Also known as: Fezolinetant, VEOZAH
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This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.
