New Preliminary Real-World VEOZAH™ (fezolinetant) Data Highlights Improvements in Menopause-Related Symptoms and Sleep Outcomes

• Statistically significant improvements in bothersome VMS as well as sleep quality were observed at week 12, and also seen at weeks 4 and 8, among women treated with fezolinetant¹
   
• First real-world objective sleep outcomes data demonstrate fezolinetant significantly improves women's sleep quality from baseline, including a mean reduction of 2.6 nighttime awakenings at week 12¹

NORTHBROOK, Ill., Oct 2, 2026 /PRNewswire/ -- Astellas Pharma U.S., Inc. (Head of US Commercial: Mike Petroutsas, "Astellas") presented a new preliminary analysis from the Phase 4 OPTION-VMS real-world study of non-hormonal therapies (non-HTs) for bothersome vasomotor symptoms (VMS, also known as hot flashes and night sweats) at the 2026 International Menopause Society (IMS) 20^th World Congress on Menopause. The analysis showed that VEOZAH (fezolinetant 45mg) treatment was associated with statistically significant improvements from baseline in bothersome VMS at week 12, the study's primary endpoint, and improvements were observed as early as week 4.¹ VEOZAH is approved in the U.S. for the treatment of moderate to severe VMS due to menopause.

Statistically significant improvements were also seen across patient-reported† and objective (obtained with a medical grade wearable) sleep measures for the first time at weeks 4, 8 and 12, including a mean reduction of 2.6 nighttime awakenings from baseline at week 12.¹  

Sleep disturbances are among the most commonly reported and bothersome symptoms during menopause, affecting an estimated 40–60% of menopausal women. Women with moderate to severe hot flashes are almost three times more likely to report frequent nighttime awakenings compared with women without hot flashes.²

OPTION-VMS is a Phase 4 real-world study of women prescribed non-hormonal therapies (fezolinetant, SSRIs/SNRIs* and other non-HTs e.g. gabapentin, oxybutynin) for bothersome VMS and other menopause-associated symptoms in routine clinical practice.¹ By combining women's reported sleep experiences with objective, wearable-derived actigraphy sleep data, OPTION-VMS provides new preliminary real-world insights into sleep outcomes in routine clinical practice. The study was not designed to assess differences between treatment groups.

The preliminary analysis found that women treated with fezolinetant experienced statistically significant improvements from baseline in:

• Bothersome VMS at 12 weeks (MENQOL VMS domain score), the study's primary endpoint. Improvements were also observed at weeks 4 and 8 (p<0.001 for all), with reductions from baseline exceeding the threshold for minimal clinically important difference (MCID).¹
• Patient-reported sleep disturbance (PROMIS SD SF 8b) at weeks 4, 8, and 12. Scores improved from the mild sleep disturbance range at baseline to the no sleep disturbance range by week 4, with improvements maintained through week 12 (p<0.001).¹
• Objective measures of sleep quality, including wakefulness after sleep onset (WASO), sleep efficiency, sleep latency and nighttime awakenings at weeks 4, 8 and 12 (p<0.05).¹

No new safety signals were seen with fezolinetant. Hepatic laboratory findings were mild and infrequent (2 cases of non-serious mildly elevated liver tests), none of which led to treatment or study discontinuation.¹

Prof. Marla Shapiro, C.M., Department of Family and Community Medicine, University of Toronto, Canada, and lead author of the OPTION-VMS oral presentation, commented: "Hot flashes and night sweats can have a far-reaching impact on women's daily lives, including their sleep, quality of life and overall well-being. These preliminary real-world findings add to the growing body of evidence from OPTION-VMS, demonstrating improvements in bothersome vasomotor symptoms and sleep outcomes among women treated with fezolinetant. Taken together with the broader study findings, these data contribute to a more complete understanding of women's experiences in routine clinical practice and may help inform discussions between women and their healthcare providers."

These preliminary real-world findings reinforce data from the VEOZAH clinical trial program and are complemented by interim data from the ongoing GRACE real-world study in Germany and the ongoing ADELE-AU, real world study in Australia, also being presented at the International Menopause Society (IMS) 2026.^3,4

Additional data presented at IMS 2026 provide supporting pre-clinical, clinical and real-world evidence across different study settings and geographies.^5,6,7,8,9

Shayna Mancuso, D.O., FACOG, Executive Medical Director and Head, U.S. Medical Affairs, Women's Health, Astellas
"These preliminary real-world findings provide valuable insights into outcomes observed with fezolinetant (VEOZAH), including sleep quality, among women experiencing moderate to severe hot flashes and night sweats. By evaluating women's experiences in routine clinical practice, we are building a deeper understanding of the outcomes that matter most to women and their clinicians."

Fezolinetant is a non-hormonal, selective neurokinin 3 (NK3) receptor antagonist specifically designed to block neurokinin B binding on kisspeptin/neurokinin/dynorphin neurons, which are involved in regulating the brain's temperature control center. By targeting this pathway, fezolinetant helps reduce the frequency and severity of moderate to severe VMS due to menopause.^10,11 It is currently approved in 50 countries.

† Patient-Reported Outcomes Measurement Information System Sleep Disturbance – Short Form 8b

* Selective serotonin reuptake inhibitors (SSRIs)/Serotonin and norepinephrine reuptake inhibitors (SNRIs)

About OPTION-VMS
OPTION-VMS (NCT06049797) is a Phase IV, longitudinal, observational, study of women aged 40-75 years with confirmed menopausal hot flashes and night sweats (also known as vasomotor symptoms or VMS) who were prescribed a non-hormonal therapy for the treatment of bothersome hot flashes and nights sweats by their healthcare provider in a real-world setting.¹ The primary objective of the study was to check if the hot flashes and night sweats that bother women change after 12 weeks (3 months) of treatment from baseline; additional outcomes include sleep quality, menopause-related quality of life, sexual health, mood, work productivity and safety.

About ADELE
ADELE is an ongoing real-world observational study of women in Australia over the age of 40 who are being treated with fezolinetant for moderate to severe hot flashes and night sweats, with sleep disturbances.⁴ The primary objective of the study is to evaluate improvements in real-world sleep disturbances after 12 weeks of treatment. Additional objectives include better understanding of treatment satisfaction and adherence, and treatment impacts on menopause-related quality of life (QoL) and adverse events.

About GRACE
GRACE (NCT07455812) is an ongoing 24-week real-world observational study of women in Germany who have menopausal hot flashes and night sweats and have been prescribed fezolinetant.³ The primary goal of this study is to learn about the effectiveness and safety of fezolinetant through patient surveys conducted before participants' first dose, assessed through validated patient-reported measures, including symptom improvement, menopause-related quality of life, sleep disturbance, treatment satisfaction and safety, with follow-up surveys taking place 1 week, 12 weeks and 24 weeks after their first dose. 

About VEOZAH^TM (fezolinetant 45 mg)
VEOZAH (fezolinetant 45 mg) is a selective neurokinin 3 receptor (NK3R) antagonist, currently approved in 50 countries for the treatment of moderate to severe VMS due to menopause. Fezolinetant 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 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 due to menopause.^10,11

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 needs. 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.

What is VEOZAH™ (fezolinetant)?
VEOZAH is a prescription medicine used to reduce moderate to severe vasomotor symptoms due to menopause. VEOZAH is not a hormone. Vasomotor symptoms are the feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating ("hot flashes" or "hot flushes").

IMPORTANT SAFETY INFORMATION    

What is the most important information I should know about VEOZAH?
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:

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.

Please see full Prescribing Information and Patient Information, including BOXED WARNING.

References

1. Shapiro, M. et al. (2026, September 30). Fezolinetant and real-world sleep outcomes in the phase 4 OPTION-VMS study: second preliminary analysis of patient-reported and actigraphy-derived endpoints. Abstract 2693-MA-3457 presented at the International Menopause Society (IMS) 20th World Congress on Menopause, Brazil. Available at: https://imsrio2026.com/
2. Baker FC, Lampio L, Saaresranta T, Polo-Kantola P. Sleep and Sleep Disorders in the Menopausal Transition. Sleep Med Clin. 2018 Sep;13(3):443-456. doi: 10.1016/j.jsmc.2018.04.011. PMID: 30098758; PMCID: PMC6092036
3. Römer, T. et al. (2026, September 30). GRACE: Real-world effectiveness and safety of fezolinetant for menopausal vasomotor symptoms in Germany – interim analysis. Abstract 2693-MA-3549 presented at International Menopause Society (IMS) 20th World Congress on Menopause, Brazil. Available at: https://imsrio2026.com/
4. Rodrigo, N. et al. (2026, September 30). A real-world study describing sleep outcomes among women using fezolinetant in Australia (ADELE-AU): preliminary analysis. Abstract 2693-MA-3608 presented at International Menopause Society (IMS) 20th World Congress on Menopause, Brazil. Available at: https://imsrio2026.com/
5. Terauchi, M et al. STARLIGHT 2: A Phase 3, randomized, placebo-controlled, double-blind study of fezolinetant in Japanese women with vasomotor symptoms associated with menopause.  Abstract 2693-CL-0310, presented at International Menopause Society (IMS) 20th World Congress on Menopause, Brazil. Available at: https://imsrio2026.com/
6. Wang X et al. Interim analysis of STARLIGHT 3: A Phase 3, randomized, placebo-controlled, 52-week, double-blind safety study of fezolinetant in Japanese women with vasomotor symptoms associated with menopause. Abstract 2693-CL-0311, presented at International Menopause Society (IMS) 20th World Congress on Menopause, Brazil. Available at: https://imsrio2026.com/
7. Yu, Q et al. A Phase 2, randomized, placebo-controlled, double-blind 12-week study of fezolinetant in Chinese women with vasomotor symptoms associated with menopause. Abstract 2693-CL-0313, presented at International Menopause Society (IMS) 20th World Congress on Menopause, Brazil. Available at: https://imsrio2026.com/
8. Kiso, T et al. Fezolinetant suppresses hot flash-like responses without impairing antitumor activity in the aromatase inhibitor-treated rat model. Poster number P.313 presented at International Menopause Society (IMS) 20th World Congress on Menopause, Brazil. Available at: https://imsrio2026.com/
9. Maki T et al. Fezolinetant suppresses hot flash-like responses elicited by activation of neurokinin 3 receptor signaling in common marmosets (non-clinical). Poster number P.017, presented at International Menopause Society (IMS) 20th World Congress on Menopause, Brazil. Available at: https://imsrio2026.com/
10. Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023;401(10382):1091-1102.
11. Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate to severe vasomotor symptoms associated with menopause: a phase 3 RCT. J Clin Endocrinol Metab. 2023;108(8):1981-1997.

SOURCE Astellas Pharma Inc.