Fezolinetant

Share this page on Facebook Share this page on LinkedIn Share this page on Twitter Get the RSS feed for this page Email the URL of this page to a friend Open a printable version of this page 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.

“We have made the decision that we don’t want to do rescue BD, which is to just fill that gap,” Astellas Pharma CEO Naoki Okamura said at Fierce JPM Week 2026.\n Xtandi, Astellas Pharma’s roughly $6 billion prostate cancer juggernaut by annual sales, is set to lose U.S. patent protection in 2027. As the company continues looking for external innovation to secure sustainable growth, CEO Naoki Okamura does not want the company to make acquisitions for the sole purpose of preventing a revenue decline.“We have made the decision that we don’t want to do rescue BD, which is to just fill that gap,” Okamura said during a fireside chat at Fierce JPM Week 2026. “We will invest in [the] much longer term.”Astellas has a “healthy appetite for business development,” Okamura said. But rather than as a way to scale up, dealmaking for Okamura is about “new technologies, new assets that strengthen our pipeline, or even better, a technology platform.”“We have no intention to have a large-scale M&A [deal] to elevate the size of the company,” he said.Last year, Astellas struck a potential $1.34 billion deal to license a CLDN18.2-targeted antibody-drug conjugate from Chinese biotech Evopoint Biosciences. That ADC program adds to Astellas’ first-in-class CLDN18.2 therapy Vyloy and ASP2138, a CLDN18.2 bispecific. With these three modalities, Astellas is “trying to dominate the CLDN18.2 space,” Okamura said. The bispecific agent could potentially treat patients with lower expression levels of CLDN18.2 compared with Vyloy, he explained. And, while Vyloy is currently approved alongside chemotherapy, an ADC construct holds potential to free patients from systemic chemotherapy.Astellas has not been a drugmaker defined by therapeutic areas or modalities. Having a select group of focus areas has its pros and cons, Okamura said. The upsides are apparent, including growing expertise and long-term relationships with relevant stakeholders.“The flip side is that if you stick to [a] certain therapeutic area too much, you will reduce the possibility of building up the long-term product portfolio,” Okamura said.Astellas instead starts with “biology with strong disease linkage,” Okamura explained. “We identify the best modality to address this biology. Then, we try to figure out what is the best patient population to benefit from this combination of biology-modality.”Nevertheless, Astellas intends to prioritize areas in which it already has expertise—both for internal research and business development. For now, these areas are targeted protein degradation, immuno-oncology, blindness/regeneration and genetic regulation.To navigate the post-Xtandi era, Astellas has identified five strategic brands with blockbuster sales potential. Besides Vyloy, these include Pfizer-partnered bladder cancer ADC Padcev, acute myeloid leukemia treatment Xospata, geographic atrophy med Izervay and menopause therapy Veozah.Among them, Padcev has seen explosive growth thanks to its establishment as the new standard of care in first-line bladder cancer. The Nectin-4 agent is expected to garner even more interest with its recent progress in muscle-invasive bladder cancer. Astellas is projecting Padcev peak annual sales between $2.8 billion and $3.5 billion, although the U.S. portion of that number is not booked by the Japanese pharma. In contrast to Padcev’s all-but-certain growth trajectory, the futures of Izervay and Veozah look less clear. For Izervay, Astellas’ peak sales projection ranges between $1.4 billion and $2.8 billion, and the company expects Veozah could reach around $1 billion to $1.7 billion at peak, according to Okamura’s presentation Monday at the J.P. Morgan Healthcare Conference.However, Astellas recently downgraded its Izervay sales projection from $750 million to $550 million for this fiscal year, which will end in March. Part of the problem relates to patient access, which Okamura said is difficult for Astellas to change. And it’s not just Izervay that’s suffering. Apellis Pharmaceuticals’ rival complement inhibitor Syfovre has also struggled to sustain its momentum, as the company Monday reported a preliminary 4% year-over-year sales decline for 2025.In turn, Astellas is trying to focus on the part of the drug\'s commercialization that it can control—physician education.Izervay’s initial uptake has been slower than expected because Astellas needs to educate retinal specialists about the drug’s treatment effect. Unlike other eye disease such as wet age-related macular degeneration, GA patients cannot feel how Izervay is working, Okamura told Fierce. Retinal specialists need to be assured that continued treatment with Izervay offers a better chance at disease improvement, he said. With that education effort in place, Astellas is now targeting community ophthalmologists. The company is taking a stratified approach to community outreach and is in the process of identifying key prescribers. Okamura noted that Astellas has experience targeting a relatively large, nonspecialist audience.As for menopause drug Veozah, the biggest uncertainty may lie in how competition with Bayer’s Lynkuet plays out.Okamura doesn’t view having Bayer, a women’s health veteran, as a competitor as necessarily bad given that both companies can help drive awareness. If the entire market grows bigger, Veozah may be better off even if it’s getting a smaller piece of the entire pie, the Astellas chief executive suggested.Bayer\'s Lynkuet is a dual-action drug targeting both NK3 and NK1 receptors, while Veozah, which holds a first-mover advantage, only targets NK3. Okamura argued that differentiation between the two approaches might come to the fore over time as real-world data emerge. Beyond specific products, one big uncertainty hovering over Astellas is changing U.S. drug pricing policy. While many Big Pharma companies have signed most-favored-nation deals with the Trump administration, it remains unclear whether midsized drugmakers like Astellas will be required to do the same.Astellas has been watching recent developments around MFN and is preparing proactively to respond if the scope of the policy reaches the company, Okamura said.For his prediction for 2026, Okamura said he remains optimistic about the biopharma industry despite the surprising lack of deal announcements at JPM this year.“There are many things moving under this,” Okamura said. “So, I still believe that 2026 is going to be another productive and prosperous year.”