Astellas' fezolinetant fails in Asia trial after earlier successes

Just last week, Astellas Pharma (TYO: 4503) announced positive top-line results from the Phase III SKYLIGHT 4 trial investigating fezolinetant in moderate to severe vasomotor symptoms associated with menopause (VMS).

Those results are supporting regulatory filing submissions in western markets and would have prompted expectations of similar results in the similar Phase III MOONLIGHT 1 trial study in Asia.

Instead, the Japanese drugmaker has now announced that its investigational oral, non-hormonal compound did not meet the pre-defined endpoints for efficacy in MOONLIGHT 1. This was based on the 12-week data analysis in 302 participants testing fezolinetant 30 mg once daily in women in China, Korea and Taiwan.