October 27, 2025: Menopause can be a challenging time for many women, with symptoms like hot flashes and night sweats disrupting daily life. But there's good news: On October 24, 2025, the U.S. Food and Drug Administration (FDA) approved a new hormone-free pill called Lynkuet (elinzanetant) to help treat moderate to severe hot flashes caused by menopause as per press release by Bayer.
Developed by Bayer, this once-a-day medication offers a fresh option for women who can't or prefer not to use hormone therapy.
Menopause is a natural stage in a woman's life, usually starting in the 40s or 50s, when the ovaries produce less estrogen. This change can lead to vasomotor symptoms (VMS), commonly known as hot flashes. These are sudden waves of intense heat, often felt in the face, chest, and head, sometimes with sweating and flushing. 1
They can happen day or night; nighttime ones are called night sweats and can affect up to 80% of women during menopause. In fact, studies like the Study of Women's Health Across the Nation (SWAN) show that 60% to 80% of women experience these at some point, with rates varying by racial and ethnic groups. 1,2
Hot flashes can last from a few minutes to several times a day, making it hard to sleep, work, or enjoy life. Antidepressants are sometimes used off-label, but they only help modestly and can cause side effects, leading half of users to stop within three months. With hot flashes often lasting 7 to 10 years, there has been a real need for safer and long-term alternatives. 1
Lynkuet (elinzanetant) is the first drug of its kind to target two specific brain signals that include neurokinin 1 (NK1) and neurokinin 3 (NK3); these play a role in hot flashes. During menopause, dropping estrogen levels make certain brain cells (called KNDy neurons) overactive, releasing too much of chemicals like neurokinin B and substance P. This disrupts the body's temperature control, triggering hot flashes.
By blocking these signals, Lynkuet calms the brain's "thermostat" without using hormones. It's taken as a single oral pill daily, making it simple to use. This approach is similar to another recently approved drug, fezolinetant, which targets just one of these signals (NK3).
The FDA’s approval is based on strong evidence from Bayer’s OASIS clinical trials, involving over 1,400 postmenopausal women. In the key studies (OASIS 1 and 2), women taking Lynkuet saw a big drop in hot flashes and over 73% reduction in frequency after 12 weeks, compared to about 47% with a placebo (inactive pill). Improvements started as early as week 1 and lasted through the 26-week trials. 1
The longer OASIS 3 trial, lasting a full year, confirmed these benefits in a broader group of women (no minimum hot flash requirement to join). At 12 weeks, daily hot flashes dropped by about 5.4 per day with Lynkuet versus 3.5 with placebo, which is a meaningful difference. Over 50 weeks, the reductions held steady, with up to a 73.8% drop in frequency. Women also reported better sleep and improved quality of life, though the study wasn't designed to prove these statistically.
Safety-wise, Lynkuet was well-tolerated. Common side effects included drowsiness, fatigue, and headaches, mostly mild or moderate. About 30% of users had treatment-related side effects, compared to 15% on placebo. Importantly, there were no signs of liver problems, bone loss, or endometrial issues (like thickening or cancer risks). Serious side effects were rare and not linked to the drug.
"The FDA approval of Lynkuet is an important new option for women and providers who are treating moderate to severe hot flashes due to menopause," said Yesmean Wahdan, M.D., Head of Medical Affairs USA & North America at Bayer. "As a global leader in women’s healthcare with more than 100 years of research and experience, we are proud to bring this new treatment option to market for women who are going through menopause and seeking hot flash relief."
Lynkuet is expected to hit U.S. pharmacies in November 2025. It's already approved in countries like Australia, Canada, the UK, and Switzerland, with reviews ongoing in the European Union and elsewhere.
By 2030, over 1.2 billion women worldwide will be in menopause, with 47 million entering this phase each year. Symptoms like hot flashes aren't just uncomfortable, they can affect work, relationships, and overall well-being. Lynkuet (elinzanetant) fills a gap by providing a non-hormonal, effective choice that's backed by solid science. If you're experiencing menopause symptoms, talk to your doctor to see if it's right for you.
References:
1. Panay N, Joffe H, Maki PM, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial. JAMA Intern Med. Published online September 08, 2025. doi:10.1001/jamainternmed.2025.4421
2. Rebecca C. Thurston, Hadine Joffe, Vasomotor Symptoms and Menopause: Findings from the Study of Women's Health across the Nation, Obstetrics and Gynecology Clinics of North America, https://doi.org/10.1016/j.ogc.2011.05.006.
(Rh/VK)