By Harshit, WASHINGTON, Oct. 29, 2025
The U.S. Food and Drug Administration (FDA) has approved a groundbreaking non-hormonal pill, offering new hope for women suffering from moderate to severe hot flashes during menopause. The once-daily medication, elinzanetant, will be marketed under the brand name Lynkuet by Bayer and is expected to hit U.S. pharmacies in November 2025.
A First-of-Its-Kind, Hormone-Free Treatment
Unlike traditional hormone replacement therapies, Lynkuet works by blocking brain chemicals responsible for vasomotor symptoms (VMS) — the sudden sensations of heat and sweating commonly known as hot flashes and night sweats.
According to Bayer, over 80% of women experience hot flashes during menopause, and many are unable or unwilling to use hormone-based treatments due to medical or personal reasons.
“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. “There is a need for more individualized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options.”
Clinical Trials Show Promising Results
The FDA’s approval was based on data from a Phase 3 clinical trial involving 628 postmenopausal women, who took elinzanetant for 12 weeks.
- Women taking Lynkuet experienced a 73% reduction in hot flashes.
- The placebo group saw only a 47% reduction.
The benefits also lasted beyond the initial treatment period. In a year-long extension study, participants reported sustained relief from both the frequency and severity of hot flashes and night sweats.
Common side effects included drowsiness, fatigue, and headaches, but researchers said these were generally mild and temporary.
“This study not only confirmed rapid and significant symptom relief but also demonstrated sustained effectiveness for a year,” said Dr. JoAnn Pinkerton, director of midlife health at UVA Health and former executive director of the North American Menopause Society. “For women who cannot or choose not to use hormone therapy, this represents an important new option.”
Understanding How It Works
Hot flashes occur when declining estrogen levels during menopause cause nerves in the hypothalamus — the brain’s temperature-control center — to become overactive. These nerves release chemical signals called neurokinins, which trigger sudden sensations of heat, sweating, and discomfort.
Elinzanetant, like another recently approved drug fezolinetant, works by blocking neurokinin receptors, calming the brain’s overreaction and restoring temperature balance.
Both drugs belong to a new generation of non-hormonal treatments targeting the root cause of hot flashes rather than simply masking symptoms.
Expanding Options for Women
For decades, hormone replacement therapy (HRT) was the main treatment for menopause symptoms. However, many women — especially those with a history of breast cancer, blood clots, or heart disease — are advised against using hormones.
“Hot flashes can be disruptive and even debilitating,” said Claire Gill, president of the National Menopause Foundation. “It’s important that women know they have choices, and today’s approval expands those options significantly.”
Medical experts say the approval of Lynkuet could shift how doctors approach menopause care — focusing more on personalized, hormone-free solutions tailored to each patient’s health profile.
A Milestone for Menopause Care
The approval of elinzanetant marks a turning point in women’s health. As understanding of menopause deepens, researchers are uncovering the biological mechanisms that drive its most troubling symptoms — paving the way for targeted, long-term relief without hormonal risks.
“This is more than just a new drug,” Dr. Pinkerton said. “It’s a validation that menopause care is evolving and that science is catching up to women’s real needs.”