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Elinzanetant, approved in the UK in July 2025 and by the FDA in October 2025, is the first non-hormonal NK1 and NK3 receptor antagonist for moderate-to-severe menopausal vasomotor symptoms, demonstrated effective and safe in pivotal phase 2
OASIS‑3 evaluated once‑daily oral elinzanetant 120 mg vs placebo for 52 weeks in postmenopausal women with moderate–severe vasomotor symptoms. At 12 weeks elinzanetant reduced daily moderate–severe VMS frequency by a least‑squares mean diff
Bayer’s Lynkuet (elinzanetant), a first-in-class dual neurokinin 1 and 3 receptor antagonist, has received FDA approval for treatment of moderate to severe menopausal vasomotor symptoms, demonstrating sustained efficacy and favorable
This review analyzes the pivotal phase 3 trial demonstrating elinzanetant’s efficacy and safety in reducing vasomotor symptoms among women undergoing endocrine therapy for HR-positive breast cancer or prevention.
The FDA delays its review of Bayer’s elinzanetant, a novel treatment for menopause-related vasomotor symptoms, by 90 days, citing the need for additional data assessment.