TOKYO, August 7, 2026
Astellas Pharma announced the submission of a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking approval of fezolinetant, an investigational oral neurokinin 3 (NK3) receptor antagonist, for the treatment of vasomotor symptoms (VMS) associated with menopause, including hot flashes and night sweats. The application is supported by data from Japanese Phase 3 STARLIGHT™ clinical studies together with evidence from the drug’s global clinical development program. If approved, fezolinetant would become the first nonhormonal therapy in Japan targeting the NK3 receptor pathway for women experiencing menopause-related vasomotor symptoms.
Phase 3 STARLIGHT Studies Supported the Regulatory Submission
The NDA is primarily supported by results from the Phase 3 STARLIGHT 2 and STARLIGHT 3 clinical trials conducted in Japanese women with menopause-associated VMS. STARLIGHT 2 enrolled 410 participants in a randomized, double-blind, placebo-controlled study evaluating 30 mg and 45 mg doses of fezolinetant over 12 weeks, with the primary endpoint measuring the reduction in the frequency of vasomotor symptoms at Week 8. STARLIGHT 3 included 277 participants in a 52-week randomized, double-blind, placebo-controlled study designed to evaluate the long-term safety and tolerability of fezolinetant, with adverse event frequency and severity serving as the primary endpoint. Data from these studies, together with global clinical findings, formed the basis of the Japanese regulatory submission.
First Nonhormonal NK3 Receptor Therapy Could Expand Treatment Options
Fezolinetant is a selective NK3 receptor antagonist designed to block neurokinin B (NKB) signaling on KNDy neurons, a key pathway involved in regulating body temperature. By targeting the underlying neurobiology of menopausal hot flashes rather than using hormone replacement therapy, the drug offers a nonhormonal treatment approach for women experiencing moderate to severe vasomotor symptoms. The therapy has already been approved in 48 countries for menopause-related VMS, and approval in Japan would provide women with a new therapeutic option that addresses an important unmet need in women’s health.
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Submission Advances Astellas’ Women’s Health Portfolio
The NDA submission represents another regulatory milestone in Astellas Pharma’s efforts to expand its women’s health portfolio. The company noted that the anticipated impact of the Japanese filing has already been incorporated into its financial forecast for the fiscal year ending March 31, 2027. If approved by Japanese regulators, fezolinetant would strengthen Astellas’ presence in menopause care while introducing the country’s first NK3 receptor-targeted, nonhormonal treatment for vasomotor symptoms associated with menopause.
Source:Astellas Pharma press release
