FDA Approves Lynkuet for Menopause Hot Flashes

Lynkuet (elinzanetant), a once-daily nonhormonal pill developed by Bayer, was approved by the FDA to treat moderate-to-severe vasomotor symptoms (hot flashes and night sweats) related to menopause. The drug is a first-in-class dual neurokinin-1 and neurokinin-3 (NK1/NK3) receptor antagonist that targets the brain’s thermoregulatory center and may also improve sleep and mood. Approval was based on three Phase III OASIS trials showing statistically significant, clinically meaningful reductions in the frequency and severity of hot flashes versus placebo, with benefits maintained up to one year. Common side effects reported include drowsiness, fatigue and headaches. Lynkuet expands nonhormonal treatment options and joins prior nonhormonal therapies such as fezolinetant (Veozah) and paroxetine. It is expected to reach U.S. pharmacies in November after earlier approvals in other countries.