Climacteric · Nov 5, 2026

Elinzanetant for menopause-associated vasomotor symptoms: pooled analysis of two phase III trials

By Simon JA, Pinkerton JV, Nappi RE et al.

Objective This study aimed to evaluate the vasomotor symptoms (VMS) efficacy profile of elinzanetant (dual neurokinin-1 and neurokinin-3 receptor antagonist). Method Data were pooled from the phase III 26-week (12-week placebo-controlled) OASIS-1 and OASIS-2 trials, enrolling naturally/surgically postmenopausal women aged 40–65 years with ≥50 moderate-to-severe VMS per week, randomized to elinzanetant 120 mg (n = 399) or placebo (n = 397). Descriptive statistics summarized the mean VMS frequency change and proportion of participants achieving ≥75% reductions. Mixed models for repeated measures estimated least-squares (LS) mean differences between elinzanetant and placebo for mean change in VMS frequency over time, by subgroups (race/ethnicity/body mass index/smoking history) and at daytime/night-time. Results Two days after treatment initiation, greater VMS frequency reductions were observed with elinzanetant versus placebo. The LS mean difference in VMS frequency versus placebo from baseline to Week 1 was −2.03 (95% confidence interval: −2.75, −1.31; nominal p < 0.0001); reductions were maintained through Week 12. By Week 12, 50.7% of elinzanetant versus 25.2% of placebo participants achieved ≥75% reduction in VMS frequency. Greater mean reductions in VMS frequency were consistently observed with elinzanetant versus placebo across subgroups and at daytime/night-time. Conclusion Elinzanetant led to rapid, sustained reductions in VMS frequency versus placebo, consistent across diverse subgroups and at daytime/night-time, with a high proportion of treatment responders, indicating broad effectiveness for VMS treatment.

doi.org/10.1080/13697137.2026.2727308 Open access Interventions