FDA Approves Elinzanetant for Moderate-to-Severe Vasomotor Symptoms of Menopause: Daily Dose

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On October 24, 2025, we reported on the FDA approval of the investigational agent elinzanetant for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause.

The approval

Elinzanetant is the first dual neurokinin-1 (NK-1) and neurokinin-3 (NK-3) receptor antagonist to receive approval for moderate-to-severe VMS associated with menopause.

The FDA's approval is based on a phase 3 clinical program (OASIS 1, 2 and 3) which enrolled post-menopausal women aged 40-65 years experiencing moderate to severe VMS. In OASIS 1/2, women received once-daily oral elinzanetant 120 mg or placebo for 26 weeks; key endpoints included mean change in frequency and severity of VMS at weeks 4 and 12. OASIS 3, a 52-week double-blind randomized study (n = 628), confirmed sustained reductions in VMS frequency along with improvements in sleep disturbances and menopause-related quality of life. A recent meta-analysis found that elinzanetant significantly reduced the frequency of VMS compared with placebo (mean difference –23.1 episodes; 95 % CI –24.2 to –22.0) and improved intensity and sleep disturbance scores.

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