Real-world study links fezolinetant to menopause symptom gains
Industry-sponsored research presented at ENDO 2026 found improvements in hot flashes, night sweats and mood symptoms among women using fezolinetant.
By Priya Raghavan · Science Reporter
2 min read
An FDA-approved nonhormonal menopause drug was associated with improvements in hot flashes, night sweats, depression and anxiety in an ongoing real-world study, according to research presented at ENDO 2026 in Chicago. The findings matter because they examine treatment use outside the tighter eligibility rules of clinical trials.
The Endocrine Society said the industry-sponsored research is the first real-world study to assess fezolinetant’s effects on hot flashes, sleep and mood. The study, called OPTION-VMS, is evaluating women prescribed nonhormonal treatments for bothersome menopausal vasomotor symptoms.
Pauline M. Maki, a professor of psychiatry, psychology and obstetrics and gynecology at the University of Illinois Chicago College of Medicine, said hot flashes affect about 80% of women and can be a common and troublesome menopause symptom. She said women have both hormonal and nonhormonal treatment options.
What the study measured
This part of the ongoing study included 656 women ages 40 to 75 who had bothersome menopausal vasomotor symptoms, according to the Endocrine Society. All had been newly prescribed a nonhormonal treatment, including fezolinetant, SSRIs or SNRIs, or other drugs such as gabapentin and oxybutynin.
Researchers compared symptoms with each woman’s baseline. They assessed bothersome vasomotor symptoms through 12 weeks and evaluated depression and anxiety symptoms at four, eight and 12 weeks.
Among 201 women taking fezolinetant, hot flashes and night sweats improved significantly from before treatment to four, eight and 12 weeks, according to the Endocrine Society. Depression and anxiety symptoms also improved significantly by four weeks and the gains continued through 12 weeks.
The study also found mood-symptom improvements among women receiving other nonhormonal therapies. The Endocrine Society said 329 women taking SSRIs or SNRIs and 126 women taking other nonhormonal treatments had improvements in depression and anxiety symptoms from baseline at four, eight and 12 weeks.
Why real-world data matters
Maki said the findings suggest fezolinetant’s real-world benefits resemble those reported in clinical trials. She said that comparison is useful because clinical trials often use narrower enrollment criteria, and participants in those studies are often healthier than the broader patient population.
The Endocrine Society described fezolinetant as an FDA-approved nonhormonal treatment for menopausal symptoms. The research presented at the group’s annual meeting did not report new safety findings in the material released.
Maki said the results may reassure women that nonhormonal treatments can help with menopause symptoms. She said the findings support a role for fezolinetant among available nonhormonal options.
This story draws on original reporting from Medical Xpress.