Originally published on 10/27/25

Major menopause news: The Food and Drug Administration (FDA) just approved a brand-new, once-a-day pill to help treat hot flashes without the use of hormones. The drug, called elinzanetant—brand name Lynkuet—was created by pharmaceutical company Bayer and is expected to hit shelves across the country starting in November. Curious about this new menopause drug? Here’s everything you need to know.

Elinzanetant is a new hormone-free menopause drug

“This FDA approval represents a bold step forward—our first hormone-free treatment for alleviating vasomotor symptoms of menopause,” Christine Roth, the executive vice president of global product strategy and commercialization at Bayer, said in a statement. “The approval in the U.S. reflects our unwavering commitment to delivering science-driven solutions that meet women’s evolving healthcare needs and empower them to take charge of their health at every stage of life.”

Traditionally, doctors have used hormone replacement therapy (HRT), which is safe and effective for most, to help reduce the frequency and severity of hot flashes in menopausal women. That said, hormone therapy may not be right for every woman, and the new menopause drug elinzanetant offers an alternative option.  

Researchers conducted three randomized clinical trials of over 1,400 women between the ages of 40 and 65, said JoAnn Pinkerton, MD, professor and director of Midlife Health at UVA Health in the Bayer press release. They analyzed symptoms and side effects—which include fatigue, drowsiness and headaches—before presenting the new menopause drug to the FDA for approval. 

The menopause drug cut hot flashes in half

The researchers found that those who took an elinzanetant pill once daily experienced about 55 percent fewer hot flashes after 12 weeks compared to those taking a placebo pill. And those hot flashes that did still occur were less intense. Many women noted they started to feel better in as little as one to two weeks, which is typically faster than with hormone therapy. Bonus: Several study participants revealed the treatment improved their sleep, too.

“These three studies investigated the safety and efficacy of elinzanetant for the treatment of moderate to severe hot flashes due to menopause,” Pinkerton said. “Hot flashes, particularly when severe, can have an impact on women’s daily lives, and this approval provides healthcare providers with a new treatment option that can be used first-line for moderate to severe hot flashes due to menopause.”

Are hormone-free menopause drugs better than HRT? 

“When a medication is described as hormone-free, it means it doesn’t contain estrogen, progesterone or other hormones that are traditionally used in hormone replacement therapy,” explains Kate McLean, MD, board-certified ob-gyn and chief medical officer at Evvy. “Instead, it works through a different biological pathway to address symptoms like hot flashes or night sweats.” 

Dr. McLean also weighed in on whether or not elinzanetant is better for menopausal women than the typical hormone treatments. 

“For some women, this is a great option, especially those who can’t or don’t want to take hormones due to personal preference or medical contraindications (for example, a history of breast cancer or blood clots),” she explains. “However, it’s not inherently ‘better’ or ‘worse’ than hormonal therapy. It’s simply different, and what’s best depends on each woman’s health profile and symptom pattern. The key takeaway is that menopause care is not one-size-fits-all. We finally have more evidence-based choices to help women feel like themselves again, and that’s something to celebrate.” 

How to get the new menopause drug elinzanetant 

Interested in giving this new hormone-free menopause treatment a try? Your first step should be discussing the drug with your doctor after it becomes available next month. Currently, there is no word on what, if any, insurance will cover the drug. That said, Bayer has partnered with BlinkRx to make Lynkuet, the brand-name version of elinzanetant, available for as little as $25 a month for those who qualify. You can learn more on Lynkuet’s site. 

Link to original: https://www.womansworld.com/aging/menopause/fda-approves-new-menopause-pill-everything-to-know-about-lynkuet