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

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.