Astellas to Present First Real-World VEOZAH™ (fezolinetant) Data at 2025 Annual Meeting of The Menopause Society

TOKYO, Oct. 14, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that VEOZAH™ (fezolinetant), its first-in-class, targeted, non-hormonal treatment for moderate to severe vasomotor symptoms (VMS) due to menopause, will be featured in six Astellas-sponsored poster presentations during The Menopause Society 2025 Annual Meeting in Orlando, Florida, October 21-25. VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.^1,2

The presentations, which feature three Late Breaking Abstracts (LBA), will include two preliminary analyses from the OPTION-VMS study. These analyses evaluate, in a real-world setting, both the changes in the impact VMS among women beginning non-hormonal therapy (non-HT) for VMS and the effects on work productivity for women initiating non-HT to manage these symptoms. These results highlight Astellas' commitment to expanding clinical knowledge about VEOZAH beyond the pivotal trials to help improve the lives of all those impacted by VMS due to menopause.

Karla Martins, Executive Medical Director for Global Medical Affairs, Astellas

"Astellas is dedicated to expanding the clinical understanding of our medicines. We are pleased to share comprehensive data on fezolinetant at this year's TMS meeting. These results provide further evidence of the efficacy and safety of fezolinetant as a treatment option for moderate to severe VMS due to menopause."

Fezolinetant data to be presented as posters during the 2025 Annual Meeting of The Menopause Society include:

• OPTION-VMS: Preliminary Analysis of a Phase IV Observational, Real-World Study of Non-hormonal Pharmacotherapies for Bothersome Menopause-Associated Vasomotor Symptoms [Abstract ID: 4380798 / Poster #: P-127, Genevieve Neal-Perry, Samuel Lederman, Shayna Mancuso, Arianne Schild, Michele Helbing, Aki Shiozawa, Karla Martins, Pauline Maki, Rebecca Thurston]
• Preliminary Analysis of Work Productivity Outcomes in OPTION-VMS: A Phase IV Observational, Real-World Study of Non-hormonal Treatment for Bothersome Menopause-Associated Vasomotor Symptoms [Abstract ID: 4380913 / Poster #: P-108, Pauline Maki, Shayna Mancuso, Michele Helbing, Arianne Schild, Karla Martins, Genevieve Neal-Perry, Rebecca Thurston]
• A Matching-Adjusted Indirect Comparison of Fezolinetant and Elinzanetant for the Treatment of Vasomotor Symptoms Due to Menopause [Abstract ID: 4343203/ Poster #: P-154, Maria Shapiro, Petra Stute, Antonia Morga, Ting-an Tai, Mayank Ajmera, Bogdan Muresan, Karla Martins, Yechu Hua, Angela Zhao, Jingyi Liu, Rossella Nappi]
• Prior Treatment Patterns and Healthcare Resource Utilization of Individuals Who Received Fezolinetant Treatment: A Claims Database Analysis [Abstract ID: 4308801 / Poster #: P-38, Barbara DePree, Mayank Ajmera, Valery Walker, Hannah Clark, Di Zhao, Christina Steiger, Michele Helbing]
• Vasomotor Symptoms Due to Menopause after Treatment Discontinuation in Phase 3 Fezolinetant SKYLIGHT Studies [Abstract ID: 4342174 / Poster #: P-128, Genevieve Neal-Perry, Petra Stute, Karla Martins, Arianne Schild, Xuegong Wang, Rossella Nappi]
• Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause in Participants with Medical Comorbidities: Pooled Analysis of Three 52-Week Phase 3 Studies (SKYLIGHT 1, 2, and 4) [Abstract ID: 4342237 / Poster #: P-158, Andrea Singer, Michele Helbing, Arianne Schild, Kaitlin Montagano, Karla Martins, Risa Kagan, Antonio Cano]

An additional poster presentation will highlight results from a survey to understand factors contributing to healthcare and treatment perceptions for menopause and related VMS among non-Hispanic/Latino black or African American women in the US.

Posters will be presented on Thursday, October 23, 6:15 – 7:15 PM.

About OPTION-VMS

OPTION-VMS (NCT06049797) is an ongoing Phase IV, longitudinal, observational, study on women aged 40-75 years with confirmed menopausal VMS who were prescribed a non-hormonal therapy (non-HT) for the treatment of bothersome VMS by their healthcare provider in a real-world setting. The primary objective of the study is to evaluate the change in VMS bother in women; additional outcomes include sleep quality, menopause-related quality of life, sexual health, mood and work productivity. A total of 998 women were enrolled at 50 sites in the U.S.

About the BRIGHT SKY™ Phase 3 Program

The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 menopausal women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 menopausal women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe.

About VEOZAH™ (fezolinetant)

VEOZAH (fezolinetant) is a nonhormonal neurokinin 3 (NK3) receptor antagonist indicated in the United States for the treatment of moderate to severe vasomotor symptoms (hot flashes and night sweats) due to menopause. VEOZAH works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/ dynorphin (KNDy) neuron to modulate neuronal activity in the brain's temperature control center (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS due to menopause ^3,4,5

U.S. Important Safety Information

VEOZAH can cause serious side effects, including: 

• Liver Problems. Your healthcare provider will do a blood test to check your liver before you start taking VEOZAH. Your healthcare provider will also do this blood test monthly for the first 3 months, at month 6, and month 9 after you start taking VEOZAH or if you have signs or symptoms that suggest liver problems. If your liver blood test values are elevated, your healthcare provider may advise you to stop treatment or request additional liver blood tests.

Stop VEOZAH right away and call your healthcare provider if you have the following signs or symptoms of liver problems: 

• feeling more tired than you do usually
• decreased appetite
• nausea
• vomiting
• itching
• yellowing of the eyes or skin (jaundice)
• pale feces
• dark urine
• pain in the stomach (abdomen)

Do not use VEOZAH if you: 

• have cirrhosis.
• have severe kidney problems or kidney failure.
• are taking certain medicines called CYP1A2 inhibitors. Ask your healthcare provider if you are not sure.

Before you use VEOZAH, tell your healthcare provider about all your medical conditions, including if you: 

• have liver disease or problems.
• have kidney problems.
• have any medical conditions that may become worse while you are using VEOZAH.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VEOZAH may affect the way other medicines work, and other medicines may affect how VEOZAH works.

The most common side effects of VEOZAH include: 

• stomach (abdominal) pain
• diarrhea
• difficulty sleeping (insomnia)
• back pain
• hot flashes or hot flushes

These are not all the possible side effects of VEOZAH. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, please see the full Prescribing Information and Patient Product Information for VEOZAH (fezolinetant).

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.

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 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.

⁴ 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. 

⁵ Fraser GL, Hoveyda HR, Clarke IJ, et al. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Endocrinology. 2015;156:4214-4225. 

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SOURCE Astellas Pharma Inc.