Astellas Reports VEOZAH Data Improving Menopause Symptoms

Northbrook, Illinois, U.S., October 2, 2026

VEOZAH Shows Improvements in Menopause Symptoms

The preliminary analysis found that women treated with fezolinetant 45 mg experienced statistically significant improvements from baseline in bothersome VMS at week 12, which was the primary endpoint of OPTION-VMS. Improvements were also observed at weeks 4 and 8, with reductions exceeding the study’s threshold for a minimal clinically important difference. These findings are relevant because hot flashes and night sweats are among the most common and disruptive symptoms associated with menopause and can affect daily activities, quality of life and sleep. The OPTION-VMS study is designed to examine outcomes among women prescribed non-hormonal therapies for bothersome hot flashes and night sweats in routine clinical practice. Unlike controlled clinical trials, real-world observational studies can provide additional insight into how treatments perform among patients receiving care in everyday healthcare settings. Importantly, the study was not designed to compare differences between treatment groups, meaning the preliminary findings should be interpreted as changes from baseline among women receiving the respective therapies rather than as a head-to-head comparison.

Real-World Sleep Data Add New Evidence

One of the notable aspects of the new analysis is the inclusion of both patient-reported and objective sleep measurements. Astellas reported statistically significant improvements in patient-reported sleep disturbance at weeks 4, 8 and 12. Objective measurements obtained through a medical-grade wearable device also showed improvements in several sleep-quality parameters, including wakefulness after sleep onset, sleep efficiency, sleep latency and nighttime awakenings. At week 12, women treated with fezolinetant experienced a mean reduction of 2.6 nighttime awakenings from baseline. Sleep disruption is a major concern during menopause, with vasomotor symptoms such as hot flashes and night sweats frequently contributing to nighttime awakenings. The OPTION-VMS analysis therefore provides additional information about the potential relationship between treatment of bothersome VMS and improvements in sleep outcomes. Astellas described the findings as the first real-world objective sleep outcomes data for fezolinetant from this study, combining wearable-derived measurements with women’s reported experiences.

Astellas Expands Real-World VEOZAH Evidence

The latest findings add to Astellas’ broader real-world evidence program for VEOZAH. The company also highlighted ongoing studies including GRACE in Germany and ADELE-AU in Australia, which are evaluating treatment outcomes in women experiencing menopause-related vasomotor symptoms and sleep disturbances. These studies are intended to provide additional information about effectiveness, safety, treatment satisfaction, adherence and quality-of-life outcomes in routine care. VEOZAH works by selectively blocking neurokinin B binding to neurokinin 3 receptors within the KNDy neuronal pathway involved in regulating the brain’s temperature-control center.

By modulating this pathway, fezolinetant is designed to reduce the frequency and intensity of moderate to severe hot flashes and night sweats. The medicine is currently approved in 50 countries, according to Astellas. The preliminary safety findings from OPTION-VMS identified no new safety signals for fezolinetant. Two cases of non-serious, mildly elevated liver tests were reported, and neither resulted in treatment or study discontinuation. Overall, the new findings contribute to the growing evidence base surrounding non-hormonal menopause treatment, while ongoing studies will provide further information about long-term outcomes in real-world clinical settings.

Source: Astellas press release