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# Bayer Dual-Neurokinin Menopause Drug Approved
- URL: https://www.fdaweb.com/bayer-dual-neurokinin-menopause-drug-approved/
- Published: 2025-10-24T12:00:00.000Z
- Updated: 2026-09-14T15:24:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160105

FDA has approved Bayer’s Lynkuet (elinzanetant) to treat moderate to severe vasomotor symptoms, or hot flashes, associated with menopause, marking the first U.S. approval for a therapy that targets both neurokinin 1 (NK1) and neurokinin 3 (NK3) receptors. Approval was based on data from Bayer’s Phase 3 OASIS clinical program, including three randomized, placebo-controlled trials, according to the company. Across OASIS 1 and OASIS 2, the therapy reduced both the frequency and severity of hot flashes during the day and night at weeks 4 and 12, meeting all co-primary endpoints, it says.