Overview
- In the 52-week OASIS-3 trial of more than 600 postmenopausal women across North America and Europe, daily 120 mg elinzanetant outperformed placebo in reducing vasomotor symptoms.
- By week 12, participants taking elinzanetant saw over a 73% reduction in frequency and severity of hot flashes and night sweats versus 47% with placebo.
- At week 50, the elinzanetant group averaged 1.4 moderate-to-severe events per day compared with 3.5 per day on placebo.
- Safety analyses found no harmful effects on liver function or bone density; the most common treatment-related side effects were headaches, sleepiness and fatigue, reported in about 30% on elinzanetant versus 15% on placebo.
- The drug is approved in the UK and Canada, where it is marketed as Lynkuet, and remains under U.S. FDA review following a July delay.