Astellas women's health pipeline
Astellas is the lead sponsor of 4 active trials in the conditions TrialsForHer tracks (Menopause), 2 of them open to recruitment now or about to open.
Trials
Open trials first, then by primary completion date. Phases: Phase 3: 3, Observational: 1. "est." marks the sponsor's estimated date; CTIS search results don't include primary completion dates. Registry sponsor names grouped here: Astellas Pharma Europe Ltd.; Astellas Pharma Global Development Inc.; Astellas Pharma Global Development, Inc.; Astellas Pharma Inc.
| ID | Title | Condition | Lead sponsor | Phase | Status | Primary completion | Enrolment | Site countries |
|---|---|---|---|---|---|---|---|---|
| NCT07602530 ClinicalTrials.gov | A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice | Menopause | Astellas Pharma Europe Ltd. | Observational | Recruiting | 28 Feb 2027 (est.) | 238 | Canada |
| NCT07829653 ClinicalTrials.gov | A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause | Menopause | Astellas Pharma Inc | Phase 3 | Not yet recruiting | 31 Mar 2028 (est.) | 100 | — |
| NCT06440967 ClinicalTrials.gov | A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy | Menopause | Astellas Pharma Global Development, Inc. | Phase 3 | Active, not recruiting | 25 Jun 2026 | 982 | Canada, Czechia, Denmark, France +7 |
| 2024-510719-31-00 EU CTIS | A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women with Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy | Menopause | Astellas Pharma Global Development Inc. | Phase 3 | Ongoing, recruitment ended | — | — | Czechia, Denmark, France, Germany +5 |
See also: upcoming women's-health trial readouts · Endometriosis trials · PCOS trials · Menopause trials
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