JoAnn V. Pinkerton, MD, MSCP, on elinzanetant across menopause subpopulations at TMS 2026

Elinzanetant, a dual neurokinin 1 and 3 receptor antagonist approved for moderate-to-severe vasomotor symptoms (VMS) due to menopause, was the subject of several analyses presented at The Menopause Society Annual Meeting 2026 in San Diego, California, examining how the therapy performs across menopause subpopulations and outcomes, according to co-author JoAnn V. Pinkerton, MD, MSCP, the Mamie A. Jessup Professor of Obstetrics and Gynecology and Division Director for Midlife Health at the University of Virginia.

“We want to know whether it works as well in women with late perimenopause as it did in the overall trials,” Pinkerton said, describing an understudied group that includes women experiencing natural or surgical menopause.

Efficacy in late perimenopausal women

In a post hoc subgroup analysis of pooled OASIS-1, -2, and -3 data, 32 late perimenopausal women, identified using STRAW+10 criteria, received elinzanetant or placebo.¹ At week 12, VMS frequency fell by 9.68 episodes with elinzanetant versus 3.44 with placebo, with numerically greater improvements in VMS severity, sleep disturbance, and menopause-related quality of life; the analysis was descriptive, with no statistical testing performed.¹

“Late perimenopause is an understudied population, and the results were very encouraging because we saw the same findings as in the global trials,” Pinkerton said. “This makes us hopeful that a randomized clinical trial specifically in women with late perimenopause would produce similarly positive results.”

Improvements in sleep

A separate pooled analysis of OASIS-1 and -2 examined eight PROMIS Sleep Disturbance Short Form 8b items in women with natural or surgical menopause who were enrolled for VMS rather than sleep complaints.² By week 12, a greater proportion of women improved across all eight items with elinzanetant than placebo; the proportion reporting poor or very poor sleep quality fell from 65.6% to 20.5% with elinzanetant, versus 57.8% to 38.7% with placebo.²

“Seeing that improvement makes us think that women with significant sleep disturbances may experience clinically meaningful benefits in sleep,” Pinkerton said, pointing to gains in sleep disturbance, sleep quality, and how refreshed women felt. “These are all really important outcomes for menopausal women.”

Magnitude of VMS reduction in the US population

A pooled analysis of 410 US participants from OASIS-1 and -2 characterized the magnitude of VMS reduction.³ As early as week 4, 66.9% of the elinzanetant group achieved at least a 50% reduction in moderate-to-severe VMS, the threshold considered clinically meaningful; by week 26, 75.2% had achieved at least a 50% reduction and 40.4% at least a 90% reduction.³

“A 50% reduction in hot flashes is considered clinically meaningful, particularly because elinzanetant was effective for severe hot flashes,” Pinkerton said.

Find full results of this study here.

A pooled safety analysis of elinzanetant’s phase 2 and 3 trials found that headache, fatigue, and somnolence were the most common treatment-emergent adverse events over weeks 1 through 12, though overall frequency was low with both elinzanetant and placebo.⁴ Most first-time events were mild or moderate, occurred within the first 2 weeks of treatment, and resolved over time.⁴

References

1. Pinkerton JV, Simon JA, Panay N, et al. Rapid and sustained reductions in VMS frequency and severity with elinzanetant in late perimenopausal women: pooled subgroup analysis from the OASIS-1–3 trials. Presented at: The Menopause Society Annual Meeting. October 20-24, 2026. San Diego, California.
2. Simon JA, Pinkerton JV, Seitz C, et al. Improvements in sleep disturbance with elinzanetant: analysis of PROMIS SD SF 8b domains from the OASIS-1 and -2 clinical trials. Presented at: The Menopause Society Annual Meeting. October 20-24, 2026. San Diego, California.
3. 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. Presented at: The Menopause Society Annual Meeting. October 20-24, 2026. San Diego, California.
4. Simon JA, Nappi RE, Panay N, et al. Headache, fatigue, and somnolence as adverse events across elinzanetant’s clinical trials: a pooled safety analysis. Presented at: The Menopause Society Annual Meeting. October 20-24, 2026. San Diego, California.