Astellas Pharma Inc. announced dosing of the first patient in the STARLIGHT? 2 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of vasomotor symptoms (VMS) associated with menopause in Japanese women. In Japan, two Phase 3 clinical studies are underway.

STARLIGHT 2 is evaluating the efficacy and safety of fezolinetant once-daily through 12 weeks. STARLIGHT 3 is evaluating the safety and tolerability of fezolinetant once-daily through 52 weeks. Dosing for the STARLIGHT Phase 3 clinical studies was determined based on available global data, including the STARLIGHT Phase 2b study (NCT05034042) that enrolled 147 patients and completed in 2022.

Primary results of STARLIGHT Phase 2b were presented at the Annual Meeting of the Japan Society for Menopause and Women's Health on December 3, 2023.