Phase 3 Trial of Fezolinetant in Japan Reports Positive Topline Results for Menopausal Vasomotor Symptoms (VMS)
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced topline results from the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant in Japan, an investigational oral, nonhormonal compound being studied for the treatment of vasomotor symptoms (VMS) associated with menopause, has met the primary endpoint. VMS, characterized by hot flashes, sweating and night sweats, are common symptoms of menopause and can have a significant impact on women’s quality of life.1,2
The study, which enrolled 410 Japanese women experiencing VMS associated with menopause demonstrated a statistically significant improvement in frequency of VMS from baseline to week 8 for fezolinetant 30 mg and 45 mg once daily versus placebo. Serious Treatment Emergent Adverse Events (TEAE) occurred in less than 4% of patients, and adverse events were consistent with the known safety profile.
Full study results will be submitted for publication and presentation at an upcoming scientific congress in late 2026. The data will also be used to support regulatory filing in Japan.
Fezolinetant was first approved as VEOZAH™ by the U.S. Food and Drug Administration (FDA) in May 2023. To date, fezolinetant has been approved in 45 countries, and is now available in 36 countries worldwide.
Astellas has already reflected the impact from this result in its financial forecast of the current fiscal year ending March 31, 2025.
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 randomized to this study per treatment arm ( 30 mg, 45 mg or placebo). The primary endpoint is mean change in the frequency of VMS from baseline to week 8, with total treatment duration of 12 weeks.
About Fezolinetant
Fezolinetant is an investigational oral, nonhormonal medicine in clinical development in Japan for the treatment of VMS associated with menopause. VMS are also known as hot flashes or night sweats. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron, helping restore the balance in the brain’s temperature control center (the hypothalamus) to reduce the number and intensity of hot flashes and night sweats.3,4,5
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women’s health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.
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