20 completed, 6 recruiting, 3 not yet recruiting, 1 active not recruiting. 12 Phase 3, 9 Phase 2, 7 Phase 1, 1 Phase 4.
Follow fezolinetant: new trials by email Literature Review of fezolinetant trials Research Report on fezolinetant
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Hormone thERapy Effects on BRAin-HEART Health During the Menopausal Transition Transdermal estradiol, Standard of care - non hormonal - Menopause, Perimenopause | Phase 4 | Not yet recruiting | McGill University Health Centre/Research Institute of the McGill University Health Centre | 100 | 2026-11-01 | 2026-07-29 |
| A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause Fezolinetant - Hot Flashes | Phase 3 | Not yet recruiting | Astellas Pharma Inc | 100 | 2026-10-31 | 2026-09-28 |
| A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) Fezolinetant, Placebo - Vasomotor Symptoms, Prostate Cancer | Phase 2 | Recruiting | Chinese University of Hong Kong | 54 | 2026-10-05 | 2026-10-07 |
| Fezolinetant and Vascular Health and Brain Health Placebo, Fezolinetant - Menopause Hot Flashes | Phase 3 | Not yet recruiting | Rebecca Thurston | 220 | 2026-09-25 | 2026-08-19 |
| A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer fezolinetant, enzalutamide, apalutamide - Prostate Cancer | Phase 1 | Recruiting | Astellas Pharma Global Development, Inc. | 56 | 2026-09-25 | 2026-10-16 |
| Focusing on the Menopausal Transition to Improve Mid-Life Women's Health Metformin, semaglutide, Anti-hypertensives - Menopause, Menopause Hot Flashes | Phase 2 / Phase 3 | Recruiting | University of Colorado, Denver | 200 | 2026-03-01 | 2026-07-21 |
| Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer Fezolinetant - Prostate CA, Androgen Deprivation Therapy | Phase 2 | Recruiting | University of Vermont | 32 | 2025-12-18 | 2026-02-05 |
| FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy Fezolinetant, Placebo - Breast Cancer Early Stage Breast Cancer (Stage 1-3) | Phase 2 | Recruiting | Yale University | 92 | 2025-12-05 | 2026-06-02 |
| A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice Fezolinetant - Hot Flashes | Recruiting | Astellas Pharma Europe Ltd. | 238 | 2025-10-23 | 2026-05-22 | |
| A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause Fezolinetant, Placebo - Hot Flashes | Phase 2 | Completed | Astellas Pharma Global Development, Inc. | 150 | 2025-03-10 | 2026-03-19 |
| Fezolinetant for the Improvement of Vasomotor Symptoms in Breast Cancer Patients Taking Endocrine Therapy, VENT Trial Biospecimen Collection, Fezolinetant, Placebo Administration - Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8 | Phase 2 | Terminated | University of Michigan Rogel Cancer Center | 9 | 2024-10-31 | 2026-05-06 |
| A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause Fezolinetant - Hot Flashes | Completed | Astellas Pharma Europe Ltd. | 105 | 2024-10-29 | 2026-08-10 | |
| A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy Fezolinetant, Placebo, Tamoxifen - Hot Flashes | Phase 3 | Active not recruiting | Astellas Pharma Global Development, Inc. | 982 | 2024-07-31 | 2026-10-27 |
| A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause Fezolinetant, Placebo - Hot Flashes | Phase 3 | Completed | Astellas Pharma Inc | 277 | 2024-02-22 | 2026-04-08 |
| A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through Menopause Fezolinetant, Placebo - Hot Flashes | Phase 3 | Completed | Astellas Pharma Inc | 410 | 2024-02-16 | 2025-12-23 |
| A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats Fezolinetant, Paroxetine, Citalopram - Hot Flashes | Completed | Astellas Pharma Global Development, Inc. | 999 | 2023-11-15 | 2026-06-05 | |
| A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause Fezolinetant, Placebo - Hot Flashes | Phase 2 | Completed | Astellas Pharma Inc | 147 | 2021-11-17 | 2024-10-26 |
| A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause fezolinetant, placebo - Vasomotor Symptoms | Phase 3 | Completed | Astellas Pharma Global Development, Inc. | 453 | 2021-11-08 | 2024-10-26 |
| A Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects fezolinetant - Healthy Volunteers | Phase 1 | Completed | Astellas Pharma China, Inc. | 16 | 2021-03-24 | 2024-10-26 |
| A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants Fezolinetant - Healthy Subjects | Phase 1 | Completed | Astellas Pharma Global Development, Inc. | 16 | 2020-11-20 | 2024-10-18 |
Showing 20 of 31. Sign in to see all of them.
Hot Flashes (18) · Prostatic Neoplasms (3) · Carcinoma, Intraductal, Noninfiltrating (1) · Renal Insufficiency (1)
Astellas Pharma Global Development, Inc. (13) · Astellas Pharma Inc (5) · Astellas Pharma China, Inc. (3) · Astellas Pharma Europe Ltd. (2) · Chinese University of Hong Kong (1) · McGill University Health Centre/Research Institute of the McGill University Health Centre (1) · Ogeda S.A. (1) · Rebecca Thurston (1) · University of Colorado, Denver (1) · University of Michigan Rogel Cancer Center (1) · University of Vermont (1) · Yale University (1)
United States (14) · Canada (6) · Czechia (5) · Poland (5) · Spain (5) · United Kingdom (5) · China (4) · Japan (4) · Germany (3) · Hungary (3) · Belgium (2) · Denmark (2) · France (2) · Italy (2) · Latvia (2)
Chi Fai NG, MD (1) · Maryam Lustberg, MD (1) · Nanette Santoro, MD (1) · Norah L Henry (1) · Rebecca C Thurston, PhD (1)
PMID 39739195, PMID 37990323, PMID 38396203, PMID 38775925, PMID 40044127, PMID 41259888, PMID 31415087, PMID 32102086, PMID 36897180, PMID 36924778, PMID 37870510, PMID 38818887, PMID 38818888, PMID 39557487, PMID 40773756
2018 (2), 2015 (1), 2019 (1)