The FDA has approved Lynkuet, a 60-milligram capsule therapy from Bayer, for the treatment of moderate to severe hot flashes due to menopause.
Lynkuet is the first dual neurokinin-1 and neurokinin-3 receptor antagonist approved for this indication. The once-daily, nonhormonal medication works by modulating thermoregulation through targeted receptor inhibition.
Approval was based on data from three phase 3 clinical trials — Oasis 1, 2 and 3 — involving 1,420 women, according to an Oct. 24 news release. In Oasis 1 and 2, Lynkuet met co-primary endpoints at weeks 4 and 12 by significantly reducing the frequency and severity of hot flashes among 796 participants. Oasis 3 included 627 women and assessed safety over 52 weeks.
Lynkuet is expected to be available in the U.S. in November 2025.
