FDA Approves Bayer's Elinzanetant for Menopause Hot Flashes

The FDA has approved elinzanetant (Lynkuet; Bayer), marking it as the first dual neurokinin 1 and 3 receptor antagonist nonhormonal treatment for moderate to severe vasomotor symptoms (VMS) such as hot flashes and night sweats associated with menopause. Clinical trials under the OASIS program demonstrated elinzanetant's significant and sustained efficacy in reducing VMS frequency and severity while improving sleep and quality of life, with a favorable safety and tolerability profile sustained over 52 weeks. Unlike hormone therapy, elinzanetant offers an alternative for women who cannot or prefer not to use estrogen-based treatments, showing minimal adverse effects and no significant safety concerns related to liver function or metabolism. Bayer plans to launch Lynkuet in the U.S. imminently following its earlier approvals in the UK, Australia, Canada, and Switzerland, entering a limited nonhormonal menopause treatment market alongside drugs like Astellas’ Veozah and Brisdelle. Experts highlight elinzanetant’s rapid onset and low incidence of side effects, including no negative impact on weight or sexual function, addressing the large unmet need given that up to 80% of women experience VMS during menopause. This approval represents a significant advance in women’s health by expanding safe and effective nonhormonal options for managing menopausal symptoms.