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 and safety of fezolinetant, a drug intended to reduce hot flashes in Japanese women undergoing menopause. This research is significant as it seeks alternatives to hormone replacement therapy, which is not suitable for all women.
The study tests fezolinetant, an oral medication already approved in the US, to treat menopausal hot flashes. Participants will either receive a low or high dose of fezolinetant or a placebo, administered daily for 12 weeks. The intervention aims to provide a non-hormonal treatment option for hot flashes.
This interventional study employs a randomized, parallel assignment model with triple masking (participant, investigator, outcomes assessor) to ensure unbiased results. The primary purpose is treatment-focused, aiming to assess the drug’s effectiveness in reducing hot flashes.
The study began on February 16, 2024, with its primary completion and estimated completion dates yet to be announced. The last update was submitted on August 4, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
The successful outcome of this study could positively impact Astellas Pharma’s stock performance by expanding fezolinetant’s market reach into Asia. This development may enhance investor sentiment, especially in the context of increasing demand for non-hormonal menopause treatments. Competitors in the menopause treatment market may need to adjust strategies accordingly.
The study is ongoing, with further details available on the ClinicalTrials portal.