Elinzanetant is a dual neurokinin (NK)-1 and -3 receptor antagonist by Bayer submitted to the FDA for the non-hormonal treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. FDA extended the review time period by 90 days. In the Phase 3, double-blind, randomized, placebo-controlled OASIS 1 and OASIS 2 trials, elinzanetant led to a statistically significant decrease in the primary endpoint of daily VMS frequency and severity from baseline to weeks 4 and 12 compared to placebo (p<0.001 for all) in postmenopausal participants aged 40 to 65 years experiencing moderate to severe VMS.¹⁰ At week 4, 62.8% and 62.2% of patients in the elinzanetant groups achieved at least a 50% reduction in VMS frequency in OASIS 1 and 2, respectively, compared with 29.2% and 32.3%, respectively, in the placebo groups. At week 12, 71.4% and 74.7% of patients in the elinzanetant groups achieved at least a 50% reduction in VMS frequency the OASIS 1 and 2, respectively, compared with 42.0% and 48.3%, respectively, in the placebo groups. The Phase 3 double-blind, randomized, placebo-controlled OASIS 3 trial also demonstrated reduced VMS at 12 weeks compared to placebo (primary endpoint) and the VMS reductions were maintained for up to 52 weeks.¹¹ In clinical trials, elinzanetant was administered orally once daily. If approved, it will be the first dual NK-1 and-3 receptor antagonist indicated for VMS in the U.S and will compete with Astellas‘ fezolinetant (Veozah), a NK-3 antagonist FDA approved for the treatment of moderate to severe VMS.