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TOKYO, February 3, 2026 – 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 (fezolinetant 30 mg, fezolinetant 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. Learn more at www.astellas.com.
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
Contacts for inquiries or additional information:
Astellas Global Brand Communications
Rhian Linney
+44 (0) 7442 843226
Rhian.Liney@astellas.com
Astellas Pharma Inc.
Corporate Communications
+81-3-3244-3201
Reference
1 Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005;3:47.
2 Jones RE, Lopez KH, eds. Human Reproductive Biology. 4th ed. Waltham, MA: Elsevier, 2014:120.
3 Hill K. The demography of menopause. Maturitas. 1996 Mar;23(2):113-27. doi: 10.1016/0378-5122(95)00968-x. PMID: 8735350.
4 Depypere H, Timmerman D, Donders G, et al. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. J Clin Endocrinol Metab. 2019;104:5893-5905.
5 Fraser GL, Lederman S, Waldbaum A, et al. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Menopause. 2020; 27:382-392.
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