LYNKUET (elinzanetant) - FDA Drug Trials Snapshot and Drugs@FDA approval record

Tier 1: Established: peer-reviewed research or government health authority
Publisher: U.S. Food and Drug Administration (Drugs@FDA / Drug Trials Snapshots) · Published: October 24, 2025 · Accessed: August 11, 2026

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Claims this source supports

• Lynkuet (elinzanetant, Bayer Health Care Pharmaceuticals) was approved by the FDA on October 24, 2025, as a prescription medicine to reduce moderate to severe hot flashes (vasomotor symptoms, VMS) due to menopause.
• Lynkuet is taken as two capsules by mouth, with or without food, at about the same time each day at bedtime; for patients taking certain medicines, the dose may be reduced to one capsule each day. The approved strength is 60 mg per capsule (NDA 219469).
• FDA approval was based on evidence from three clinical studies (OASIS-1, OASIS-2, and OASIS-3) involving 1,423 participants, all female; OASIS-1 and OASIS-2 assessed efficacy, and OASIS-1/2/3 assessed safety.
• Elinzanetant is a nonhormonal medicine in a different class from hormone therapy; the drug targets neurokinin receptors involved in the brain's temperature-regulation pathway.