Astellas Presents Preliminary Real-World VEOZAH™ (fezolinetant) Data From OPTION-VMS Phase IV Observational Study

Extensive and growing evidence continues to reinforce fezolinetant as an effective treatment for moderate to severe VMS associated with menopause

Preliminary analysis from OPTION-VMS observational study demonstrated fezolinetant leads to statistically significant improvements in subjective and objective sleep outcomes

Further analysis of work productivity outcomes indicate fezolinetant leads to statistically significant improvements in activity impairment, overall work productivity loss and presenteeism

TOKYO, Oct. 22, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced new real-world preliminary data from the OPTION-VMS Phase IV, longitudinal, observational study, providing the first insights into the real-world use of fezolinetant. The data demonstrated statistically significant improvements in VMS bother related to menopause, statistically significant improvements in subjective and objective sleep outcomes and significant improvements in activity impairment including overall work productivity. VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.^1,2 These preliminary data will be presented this week as late-breaker poster presentations at The Menopause Society 2025 Annual Meeting (October 21-25) in Orlando, Florida.

The preliminary analysis of the study of more than 900 women aged 40-75 years with confirmed menopausal VMS, who were prescribed a non-hormonal therapy (non- HT) for the treatment of bothersome VMS, met its primary endpoint (measured at week 12) and other endpoints selected for this preliminary data cut (measured at weeks 4, 8 and 12). Women prescribed fezolinetant demonstrated:

• Statistically significant improvements in VMS bother related to menopause as measured by reductions in Menopause-Specific Quality of Life (MENQOL) VMS domain scores at week 12 (primary endpoints) and at weeks 4 and 8 (secondary endpoint).
• Statistically significant improvements were demonstrated at weeks 4, 8, and 12 in Total T scores, an overall measure of how menopause symptoms affect quality of life, and additional MENQOL domain scores, reflecting the categories of the total patient reported outcome measures including sexual, psychosocial and physical (secondary endpoints).
• Statistically significant reductions were observed at weeks 4, 8, 12 in patient reported sleep quality as measured by PROMIS SD SF 8b (Patient Reported Outcomes Measurement Information System Sleep Disturbance-Short Form 8) Total T scores (secondary endpoint).
• Statistically significant improvements in objective sleep outcomes based on actigraphy endpoints including wakefulness after sleep onset (WASO) at weeks 4, 8, 12, and sleep efficiency at weeks 4 and 12 (secondary endpoints).

Incidence of fezolinetant-related treatment-emergent adverse events (AEs) in the study were low and consistent with clinical trials and post marketing data. No new safety signals were observed. Preliminary safety findings will be presented at The Menopause Society, with full results available after final analysis.

Statistically significant improvements in patient reported sleep quality as measured by PROMIS SD SF 8b and MENQOL total and domain scores were also seen in the other two treatment groups, SSRIs/SNRIs and other non-HT (gabapentin, oxybutynin). No statistically significant improvements were seen in WASO, sleep efficiency or sleep latency in the SSRIs/SNRIs group. Statistically significant improvements were seen in WASO at all time points in the other non-HT group.

Furthermore, a preliminary analysis of work productivity outcomes from the study demonstrated that treating VMS associated with menopause with fezolinetant led to statistically significant improvements in Work Productivity and Activity Impairment questionnaire specific to VMS (WPAI-VMS) domains, including activity impairment, overall work productivity loss and presenteeism in a real-world setting. Statistically significant improvements were also seen in the SSRIs/SNRIs and other non-HT groups.

Genevieve Neal-Perry, M.D., Ph.D., Department Chair, UNC School of Medicine Department of Obstetrics and Gynecology
"These preliminary findings strengthen the evidence that fezolinetant is an effective treatment for women with disruptive vasomotor symptoms associated with menopause. Beyond the notable reductions in bothersome VMS as early as week 4, women reported improvements in sleep, work productivity and daily functioning. With an estimated 1.2 billion women expected to be peri- or post-menopausal by 2030, and millions experiencing symptoms that can affect their wellbeing and professional lives, addressing the burden of menopause is more important than ever."

Menopausal symptoms can pose a significant economic burden to women in middle age, causing difficulties coping at work for around a third of working women. Reports have shown that women with severe menopausal symptoms feel fatigued at work prompting some to consider changing careers, reducing their hours, or leaving the workforce which can have a substantial impact on both individuals and the economy.³

Shayna Mancuso D.O., FACOG, Head, US Medical Affairs, Women's Health-Fezolinetant, Astellas
"These new preliminary findings reinforce Astellas' commitment to advancing our understanding of fezolinetant beyond the pivotal clinical trials, with the goal of driving meaningful change for those affected by VMS. Hot flashes and night sweats are among the most common and disruptive symptoms of menopause, and when left untreated, they can significantly impair sleep, concentration, and daily functioning. We are excited by the preliminary OPTION-VMS study results and look forward to the final results."

VEOZAH™ is currently approved in 45 countries around the world, including Australia, Canada, the EU, Mexico, Singapore, Switzerland, and the U.S., among others.

About OPTION-VMS
OPTION-VMS (NCT06049797) is an ongoing Phase IV, longitudinal, observational, study of female participants aged 40-75 years with confirmed menopausal VMS who were prescribed a 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 and safety. A total of 998 women were enrolled at 50 sites in the U.S.

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 number and intensity of hot flashes and night sweats.^4,5,6

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 of 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.

SOURCE Astellas Pharma Inc.