Astellas Pharma ((ALPMF)), Astellas Pharma ((ALPMY)) announced an update on their ongoing clinical study.
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Astellas Pharma is conducting a Phase 3 clinical study titled A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Fezolinetant in Japanese Women Experiencing Vasomotor Symptoms (Hot Flashes) Associated With Menopause. The study aims to confirm the efficacy of fezolinetant in reducing hot flashes in Japanese women undergoing menopause, a significant concern as hormone replacement therapy is not suitable for all women.
The study tests fezolinetant, an oral drug already approved in the US, to treat hot flashes. Participants will receive either a low or high dose of fezolinetant or a placebo, taken daily for 12 weeks, to assess its effectiveness.
This randomized, triple-masked, parallel assignment study focuses on treatment as its primary purpose. Participants, investigators, and outcomes assessors are blinded to the treatment allocation.
The study began on February 16, 2024, with a primary completion date yet to be announced. The latest update was submitted on August 4, 2025, indicating ongoing recruitment and progress.
For investors, this study could impact Astellas Pharma’s stock positively if results show fezolinetant’s effectiveness, potentially expanding its market in Asia. The competitive landscape includes other non-hormonal treatments for menopause symptoms, which could influence market dynamics.
The study is ongoing, with further details available on the ClinicalTrials portal.