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The US Food and Drug Administration (FDA) has approved Lynkuet, a once-daily, non-hormonal pill developed by Bayer to treat moderate to severe hot flashes and night sweats in menopausal women.
The drug, known scientifically as elinzanetant, is expected to be available in the United States beginning November 2025, according to a statement released by Bayer.The medication works by blocking brain chemicals responsible for vasomotor symptoms (VMS), the sudden sensations of heat and sweating that affect more than 80% of women during menopause. Bayer called the approval “a bold step forward” in menopause care, noting that it offers women a much-needed alternative to hormone-based therapies.“This FDA approval represents a bold step forward, our first hormone-free treatment for alleviating vasomotor symptoms of menopause,” said Christine Roth, Bayer’s executive vice president of global product strategy and commercialization, in a company news release on Friday. “There is a need for more individualized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options.
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Lynkuet offers a non-hormonal alternative for hot flashes
Hormone therapy remains one of the most effective treatments for menopause symptoms, but it isn’t suitable for all women, especially those with a history of certain cancers or medical conditions. For such women, non-hormonal options like Lynkuet offer new hope.A Phase 3 clinical trial published in JAMA Network involving 628 postmenopausal women found that those taking elinzanetant for 12 weeks experienced a 73% reduction in the frequency of hot flashes and night sweats, compared to a 47% reduction among those who received a placebo.
The results were published last month and confirmed sustained improvements over a full year.“This yearlong study not only confirmed the initial findings of rapid and significant reduction in the frequency and severity of hot flashes and night sweats but also provided evidence that these effects were sustained over a year, offering hope for longer-term relief,” said Dr. JoAnn Pinkerton, director of midlife health at UVA Health and emeritus executive director of the North American Menopause Society.
The most common side effects observed during the trials included drowsiness, fatigue, and headaches, Bayer said.
Understanding how Lynkuet works
Elinzanetant is part of a new class of drugs targeting the neurokinin pathway in the brain—a mechanism recently linked to hot flashes and night sweats. As estrogen levels decline during menopause, the hypothalamus, the brain’s temperature-regulating center, becomes hyperactive and releases excess chemical signals called neurokinins.By blocking neurokinin receptors, Lynkuet reduces the brain’s overreaction, calming the heat-regulating system and preventing sudden temperature spikes. A similar non-hormonal drug, fezolinetant, was approved by the FDA in 2023 and works through the same pathway.
English (US) ·