On October 24, 2025, the U.S. Food and Drug Administration (FDA) approved Lynkuet™ (elinzanetant), developed by Bayer, as the first dual neurokinin (NK) targeted therapy—a combined NK1 and NK3 receptor antagonist—for the treatment of moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, due to menopause. This non-hormonal, once-daily oral therapy addresses a major unmet need in menopausal care, where VMS affect daily functioning, sleep, and quality of life and are a primary reason women seek medical intervention.
The approval is grounded in the Phase III OASIS clinical program, comprising three randomized, double-blind, placebo-controlled, multicenter trials. OASIS 1 and 2 enrolled 796 postmenopausal women and demonstrated elinzanetant’s efficacy over 12 weeks, meeting both co-primary endpoints: statistically significant reductions in the mean frequency and severity of moderate to severe VMS (day and night) from baseline at weeks 4 and 12. Clinically meaningful improvements were observed early and sustained throughout the treatment period. OASIS 3 evaluated long-term safety in 627 women, with elinzanetant or placebo administered for up to 52 weeks, confirming a favorable safety profile with no new concerns.
Elinzanetant acts by inhibiting Substance P and neurokinin B signaling via NK1 and NK3 receptor antagonism on kisspeptin/neurokinin B/dynorphin (KNDy) neurons in the hypothalamus. Age-related estrogen decline triggers KNDy neuron hyperactivity, disrupting thermoregulation and causing VMS. By modulating this pathway, elinzanetant restores balance without hormonal intervention, offering a novel mechanism distinct from existing therapies. With an estimated 1.2 billion women projected to experience menopause globally by 2030—47 million entering annually—VMS remain a significant burden, often accompanied by sleep disturbances and mood changes. Lynkuet™ provides a hormone-free, first-line option for moderate to severe cases, expanding treatment choices and supporting individualized menopause management. The therapy has also secured approval in Australia, Canada, the UK, and Switzerland, with applications pending in the European Union and other markets.
Bayer’s century-long commitment to women’s health underscores this milestone, aligning with its broader mission to advance non-hormonal innovations in menopause, contraception, and gynecological care. Lynkuet™ is expected to launch in the U.S. in November 2025, marking a significant advancement in science-driven, patient-centered menopausal symptom relief.
