Astellas’ MOONLIGHT 1™ clinical trial evaluating investigational fezolinetant 30 mg administered once daily

TOKYO, March 15, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced topline results from the ongoing Phase 3 MOONLIGHT 1™ clinical trial investigating the efficacy and safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS), in women in Asia. VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.1,2 

Based on the 12-week data analysis in 302 participants, fezolinetant 30 mg once daily (QD) in women in China, Korea and Taiwan did not meet the pre-defined endpoints for efficacy. While numerical improvements from baseline were observed in the fezolinetant 30 mg treatment group, the results did not meet statistical significance. The 12-week safety data in this study are aligned with what was previously observed with fezolinetant. Detailed results will be submitted for publication following completion of the 24-week analyses. 

“We are evaluating the results and look forward to reviewing the full data set once the study is complete,” said Nancy Martin, M.D., PharmD, Vice President, Global Medical Head, Medical Specialties, Astellas.

MOONLIGHT 1 is an ongoing randomized Phase 3 clinical trial evaluating the efficacy and safety of fezolinetant in 302 women in China, Korea and Taiwan who take fezolinetant 30 mg QD for 24 weeks. The trial is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. Specifically, the MOONLIGHT 1 study is being conducted to support registration in China, Korea and Taiwan. As previously reported, the results from two pivotal Phase 3 clinical trials, SKYLIGHT 1™ and SKYLIGHT 2™, along with the findings from the long-term safety study, SKYLIGHT 4™, will provide the foundational data for regulatory submissions in the U.S. and Europe.

Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist. The efficacy and safety of fezolinetant are under investigation and have not been established.

This result will have no impact on the financial forecasts of the current fiscal year ending March 31, 2022.


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