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Phase 3b Trial of Fezolinetant Shows Positive Topline Results for Treatment of VMS Due to Menopause

Study evaluated 24-week efficacy and safety of Astellas’ fezolinetant in women considered unsuitable for hormone therapy


Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive topline results from the Phase 3b DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2

The study, comprised of more than 450 women considered unsuitable for hormone therapy, met the primary objective showing statistically significant reduction from baseline in the frequency of moderate to severe VMS to week 24 for fezolinetant 45 mg once daily versus placebo. Serious treatment emergent adverse events (TEAE) occurred in less than 5% of patients, and the most common TEAEs were COVID-19 and headache. Detailed results will be submitted for publication and for consideration at an upcoming medical meeting.

Marci English, Vice President, Head of BioPharma Development, Astellas
“We are delighted the initial assessment of the DAYLIGHT study further validates the role of fezolinetant in reducing the frequency of moderate to severe VMS due to menopause. These 24-week placebo-controlled data add to our growing base of clinical evidence established in the SKYLIGHT studies and provide additional insights on the safety and effectiveness of fezolinetant in women who cannot or choose not to take hormone therapy.”

Fezolinetant was approved as VEOZAH by the U.S. Food and Drug Administration (FDA) in May 2023, and Astellas is pursuing regulatory approval for fezolinetant in several other countries and regions, including Europe. The DAYLIGHT study generated additional efficacy and safety data to primarily support health technology assessment (HTA) and reimbursement dossiers throughout Europe.

Astellas has already reflected the impact from this result in its financial forecast of the current fiscal year ending March 31, 2024.


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Phase 3b Trial of Fezolinetant Shows Positive Topline Results for Treatment of VMS Due to Menopause

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