JoAnn Pinkerton, MD, on Counseling Patients Starting Elinzanetant for VMS

Elinzanetant produced rapid, progressively greater reductions in moderate-to-severe vasomotor symptoms (VMS), while its most frequently reported adverse events generally emerged early and were mild or moderate, according to 2 pooled analyses presented at The Menopause Society 2026 Annual Meeting in San Diego. In an interview, JoAnn V. Pinkerton, MD, MSCP, of University of Virginia Health, discussed how the findings can guide primary care counseling and follow-up.

The efficacy analysis included 410 US participants from the phase 3 OASIS-1 and OASIS-2 trials. Participants aged 40 to 65 years with at least 50 moderate-to-severe VMS episodes per week received elinzanetant 120 mg or placebo for 12 weeks, followed by elinzanetant for both groups through week 26. By week 12, 66.9% of elinzanetant-treated participants achieved at least a 50% reduction in VMS frequency, compared with 40.5% receiving placebo. Reductions of at least 75% and 90% were reported in 46.5% and 29.1% of the elinzanetant group, respectively. Pinkerton said patients may notice improvement within 1 week, with additional gains over time.

A separate pooled safety analysis evaluated 765 elinzanetant-treated participants and 754 placebo recipients through 12 weeks. Headache, fatigue, and somnolence occurred in 7.6%, 5.4%, and 3.4% of the elinzanetant group, respectively. Most first events occurred during the first 2 weeks. Nearly all were mild or moderate, with one severe headache reported. By 12 weeks after onset, 73.7% of first headache events, 43.9% of fatigue events, and 73.1% of somnolence events had resolved.

For PCPs, Pinkerton recommended setting expectations at treatment initiation: symptom relief may begin quickly and continue to build, while early fatigue, headache, or somnolence may diminish with time. This counseling may help patients distinguish expected, transient effects from symptoms requiring reassessment and support persistence when the initial response is slower than anticipated.

References:

1. Simon JA, Nappi RE, Panay N, et al. Headache, fatigue, and somnolence as adverse events across elinzanetant’s clinical trials: a pooled safety analysis. Abstract S-3. Presented at: The Menopause Society 2026 Annual Meeting; San Diego, CA.
2. Pinkerton JV, Tough DeSapri K, Clark A, et al. Proportion of postmenopausal participants achieving ≥50% reduction in moderate-to-severe vasomotor symptom frequency with elinzanetant: pooled US population data from OASIS-1 and OASIS-2. Abstract S-5. Presented at: The Menopause Society 2026 Annual Meeting; San Diego, CA.