Treats moderate to severe vasomotor symptoms due to menopause. Sold as Veozah. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Fezolinetant (sold as Veozah), first approved May 12, 2023, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Veozah | Part D | $76.5M | +99% | 22,946 |
| A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through MenopauseHot Flashes · Astellas Pharma Inc | Phase 3 | Recruiting | Sep 21, 2026 |
| A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate CancerProstate Cancer · Astellas Pharma Global Development, Inc. | Phase 1 | Recruiting | Aug 24, 2026 |
| Hormone thERapy Effects on BRAin-HEART Health During the Menopausal TransitionMenopause, Perimenopause · McGill University Health Centre/Research Institute of the McGill University Health Centre | Phase 4 | Not yet recruiting | Jul 29, 2026 |
| Fezolinetant and Vascular Health and Brain HealthMenopause Hot Flashes · Rebecca Thurston | Phase 3 | Not yet recruiting | May 26, 2026 |
| A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical PracticeHot Flashes · Astellas Pharma Europe Ltd. | — | Recruiting | May 22, 2026 |
| A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)Vasomotor Symptoms, Prostate Cancer · Chinese University of Hong Kong | Phase 2 | Recruiting | May 5, 2026 |
| Focusing on the Menopausal Transition to Improve Mid-Life Women's HealthMenopause, Menopause Hot Flashes · University of Colorado, Denver | Phase 2 / Phase 3 | Recruiting | May 16, 2025 |
| Fezolinetant for Treating Hot Flashes in Men With Prostate CancerProstate CA, Androgen Deprivation Therapy · University of Vermont | Phase 2 | Recruiting | May 15, 2025 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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