Bayer's Lynkuet® (elinzanetant) Becomes the First FDA-Approved Neurokinin 1 and 3 Receptor Antagonist for Treating Moderate to Severe Menopausal Hot Flashes

FDA Approval of Lynkuet: The U.S. Food and Drug Administration (FDA) has approved Lynkuet (elinzanetant) as the first dual neurokinin receptor antagonist for treating moderate to severe hot flashes due to menopause, supported by data from the Phase III OASIS clinical trials.

Efficacy and Safety Trials: Lynkuet demonstrated significant efficacy in reducing the frequency and severity of hot flashes in two randomized trials involving 796 menopausal women, with safety evaluated in a total of 1,420 women across three trials.

Treatment Accessibility: Bayer aims to make Lynkuet accessible through the Lynkuet Access Savings & Support program, allowing women to connect with healthcare providers and receive prescriptions at lower costs, with availability expected in the U.S. starting November 2025.

Important Safety Information: Lynkuet is not recommended for pregnant women and may cause serious side effects, including central nervous system effects and increased liver enzyme levels; common side effects include headache, fatigue, and dizziness.