A brand-new drug has been approved that tackles moderate to severe hot flashes without using hormones.
Called elinzanetant (brand name Lynkuet), it works by targeting neurokinin 1 and neurokinin 3 receptors in the brain.
The approval is backed by robust clinical trial data and gives women a fresh treatment alternative for menopause-related vasomotor symptoms.
The U.S. Food & Drug Administration (FDA) has approved Lynkuet (elinzanetant), manufactured by Bayer, for women with moderate to severe vasomotor symptoms (hot flashes) due to menopause.
This news is important because for many women, hormone therapy either isn’t an option or isn’t the ideal choice. With this new approval, there’s a scientifically-backed, non-hormonal option stepping into the spotlight.
“For more than a century, Bayer has been dedicated to pioneering advances in women’s health, and this FDA approval represents a bold step forward – our first hormone-free treatment for alleviating vasomotor symptoms of menopause,” Christine Roth, Executive Vice President, Global Product Strategy and Commercialization said in a news release.
“There is a need for more individualized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options. The approval in the U.S. reflects our unwavering commitment to delivering science-driven solutions that meet women’s evolving health care needs and empower them to take charge of their health at every stage of life.”
What you need to know about Lynkuet
Lynkuet works differently from older hormone-based treatments.
Instead of supplementing estrogen or progestin, elinzanetant blocks two receptors in the brain — neurokinin 1 (NK1) and neurokinin 3 (NK3). These receptors are part of the system that regulates body temperature, and when menopause disrupts that system, it can lead to those infamous hot flashes.
Grounded in science
The approval is grounded in three Phase III clinical trials (OASIS 1, OASIS 2, and OASIS 3) that together enrolled over 1,400 women. In the first two studies, women who took elinzanetant saw meaningful reductions in both the frequency and severity of hot flashes — both during the day and at night. Study 3 extended the data up to 52 weeks to assess longer-term safety.
“These three studies investigated the safety and efficacy of elinzanetant for the treatment of moderate to severe hot flashes due to menopause,” JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health and Lead Investigator on the OASIS 2 trial said in the news release.
“Hot flashes, particularly when severe, can have an impact on women’s daily lives and this approval provides health care providers with a new treatment option that can be used first-line for moderate to severe hot flashes due to menopause.”
What this means for you
Starting in November 2025, Lynkuet is expected to become available in the U.S.
If you’ve been holding off hormone therapy or finding your current options lacking, this could offer a fresh route to get your sleep back, reduce those disruptive night sweats, and reclaim more comfortable days and nights.
Of course — as with any treatment — it’s important to talk with your health care provider to see whether this new medication is a good fit for you, especially since individual health situations vary. But the bottom line: menopause relief just got a little more flexible — and for many women, that flexibility may make all the difference.
“It’s important that women know they have choices for treating moderate to severe hot flashes due to menopause, and today’s approval further expands a woman’s options for treating these symptoms,” Claire Gill, President and Founder of the National Menopause Foundation, said in the news release.