Original Investigation

Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause

JAMA Internal Medicine 10.1001/jamainternmed.2025.4421

September 08, 2025 at 11:00 AM EDT

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Is elinzanetant effective and safe for treating moderate to severe vasomotor symptoms (VMS) in postmenopausal women?In this randomized, placebo-controlled clinical trial of 628 postmenopausal women, elinzanetant significantly reduced the frequency of daily moderate to severe VMS at 12 weeks compared to placebo, and although no statistical hypotheses were defined for secondary or exploratory end points, descriptive analyses showed numerical advantages for elinzanetant vs placebo for improving VMS frequency and severity over 50 weeks and sleep disturbances and menopause-related quality of life over 52 weeks. Elinzanetant was not associated with hepatotoxic effects, endometrial hyperplasia, or meaningful changes in bone density or bone turnover markers, and treatment-related adverse events were more common with elinzanetant than placebo.The trial results suggest that elinzanetant shows promise in treating moderate to severe VMS.

Corresponding Author: Nick Panay, MBBS, BSc, Queen Charlotte’s nickpanay@msn.com).

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