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TOKYO, August 7, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) 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.1,2
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 fezolinetant
Fezolinetant is an investigational oral, selective neurokinin 3 receptor (NK3R) antagonist in clinical development in Japan for the treatment of VMS, or hot flushes and night sweats, associated with menopause. It has also been approved in 48 countries for the treatment of moderate to severe VMS associated with menopause. Fezolinetant is designed to block neurokinin B (NKB) binding to NK3R on kisspeptin/neurokinin/dynorphin (KNDy) neurons, a pathway involved in thermoregulation.3,4,5
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.
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 document, 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 media statement is not intended to constitute an advertisement or medical advice.
Contacts for inquiries or additional information:
Astellas Pharma Inc.
Corporate Communications
+81-3-3244-3201
Rachel Norager
Lead, Global Brand Communications
+6596159221
Rachel.Norager@astellas.com
References
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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