Particle.news

Download on the App Store

Elinzanetant Cuts Hot Flashes in Yearlong Phase 3 Study

Publication of the OASIS-3 results strengthens evidence for a nonhormonal option during an ongoing U.S. review.

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.