A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause
← catalyst calendarSponsored by Astellas Pharma Inc (industry) · 4503.T — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
277actual
Sites
24
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-02-22 | actual | When the study began enrolling |
| Primary completion | 2026-03-19 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-19 | actual | The whole study's end, after follow-up |
| First posted | 2024-01-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hot Flashes
Interventions
- Drug: Fezolinetant — also filed as ESN364;, VEOZAH™
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFNumber of participants with Adverse Events (AEs)
measured Up to Week 55
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