Encouraging top-line Phase III results with fezolinetant

Japanese drug major Astellas Pharma (TYO: 4503) today announced positive top-line results from the Phase III MOONLIGHT clinical trial in women in mainland China evaluating the long-term safety and tolerability of fezolinetant, an investigational oral, non-hormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.

MOONLIGHT 3 is a 52-week single-arm Phase III clinical trial investigating the long-term safety and tolerability of fezolinetant 30mg taken once daily in 150 women in mainland China seeking treatment for relief of VMS associated with menopause. The study’s primary endpoint is the frequency and severity of adverse events (AEs), which were generally consistent with previous Phase III studies of fezolinetant. Detailed results will be submitted for publication in the near future.

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