Astellas Submits Fezolinetant NDA in Japan for Menopause-Associated Vasomotor Symptoms – Astellas Pharma
7 August 2026 – Astellas Pharma Inc. confirms it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking approval of fezolinetant, a NK3 receptor antagonist, for the treatment of vasomotor symptoms (VMS, also known as hot flushes and sweating) associated with menopause.
The submission is supported by data from clinical studies conducted in Japan including two Phase 3 STARLIGHT™ studies in Japanese women, as well as data from the global clinical development program providing supportive context. If approved, fezolinetant would be the first nonhormonal treatment option in Japan to target the NK3 receptor pathway for women experiencing VMS associated with menopause.
Astellas has already reflected the impact from this acceptance in its financial forecast of the current fiscal year ending March 31, 2027.
About STARLIGHT 2
STARLIGHT 2 (NCT06206408) is a 12-week randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to evaluate the superiority of fezolinetant versus placebo and assess the safety of fezolinetant in Japanese women experiencing VMS associated with menopause. 410 participants were enrolled in the study and randomized to the fezolinetant 30 mg or 45 mg or placebo treatment arms. The primary endpoint is mean change in the frequency of VMS from baseline to week 8, with total treatment duration of 12 weeks.
About STARLIGHT 3
STARLIGHT 3 (NCT06206421) is a 52-week randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to assess the safety and tolerability of fezolinetant in Japanese women experiencing VMS associated with menopause. 277 participants were enrolled in the study and randomized to the fezolinetant or placebo treatment arms. The primary endpoint is frequency and severity of adverse events through 52 weeks.
