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:
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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]
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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]
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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]
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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]
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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]
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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
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.
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.