Bayer Receives FDA Approval for Lynkuet, a Novel Non-Hormonal Drug for Menopausal Hot Flashes

Bayer’s Lynkuet (elinzanetant) has received FDA approval for treating moderate to severe vasomotor symptoms (hot flashes) associated with menopause125.

Lynkuet is a once-daily, non-hormonal capsule that works by blocking both NK1 and NK3 receptors, targeting the neural pathway that regulates body temperature and reducing both the frequency and severity of hot flashes14.

Approval was supported by three late-stage clinical trials involving thousands of women, demonstrating significant reduction in hot flash symptoms and improvement in quality of life and sleep1.

Lynkuet is distinct from existing non-hormonal options (e.g., Astellas’ Veozah, which targets only NK3) and is expected to be available in the U.S. next month14.

About 75% of women experience hot flashes during menopause, but only half seek treatment; current therapies include hormone therapy, antidepressants, and other medications4.

Sources:

1. https://www.biopharmadive.com/news/bayer-fda-approval-lynkuet-menopause-vasomotor-symptoms/753979/

2. https://www.fiercepharma.com/pharma/fda-nod-bayers-lynkuet-enters-limited-us-market-nonhormonal-menopause-symptom-meds

4. https://www.scrippsnews.com/health/night-sweats-and-heat-surges-new-drug-takes-aim-at-menopause-symptoms

5. https://www.drugdiscoverytrends.com/bayers-lynkuet-approved-by-fda-for-menopausal-hot-flashes/