The U.S. FDA has approved Bayer’s once-daily, non-hormonal treatment, Lynkuet, for treating moderate to severe vasomotor symptoms (hot flashes) associated with menopause.
Lynkuet is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist that inhibits Substance P and Neurokinin B. Adminstered as a once-daily softgel capsule, it is the first dual neurokinin targeted therapy to receive approval.
Lynkuet is thought to address vasomotor symptoms by modulating a group of estrogen sensitive neurons, called KNDy neurons, in the hypothalamus region of the brain. Bayer shared three positive phase 3 trial readouts for the drug in 2024, in which Lynkuet demonstrated statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12 compared to the placebo.
Lynkuet originally had a July 2025 PDUFA date, but the FDA extended the review period, citing the need for more time in order to conduct a full review of the NDA submission.