Bayer has announced that the U.S. Food and Drug Administration (FDA) has approved Lynkuet® 60mg capsules, which is the first and only dual neurokinin (NK) targeted therapy designed to treat moderate to severe hot flashes caused by menopause. The treatment acts as a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, representing a new class of therapy for menopausal women.
Lynkuet works by blocking Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signalling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons. This modulation helps regulate the thermoregulatory processes associated with hot flashes. The once-daily soft gel capsule can be taken at bedtime, with or without food.
The FDA’s decision is backed by results from three Phase III clinical trials, OASIS 1, OASIS 2, and OASIS 3, which evaluated the safety and efficacy of Lynkuet in menopausal women experiencing moderate to severe hot flashes.
“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.”
The OASIS 1 and OASIS 2 trials, randomised, double-blind, placebo-controlled studies, enrolled 796 menopausal women. Over 12 weeks, Lynkuet significantly reduced both the frequency and severity of moderate to severe hot flashes, including those occurring during the day and at night.
In total, 1,420 women participated across the three OASIS trials. The OASIS 3 study included 627 participants who received either Lynkuet or a placebo for up to 52 weeks to assess long-term safety.
While the treatment offers new hope, Bayer cautions that Lynkuet should not be taken by pregnant women. Potential risks include central nervous system effects, daytime impairment, elevated liver enzyme levels, pregnancy loss, and seizure risk in individuals with a history of seizures. Reported common side effects include headache, fatigue, dizziness, drowsiness, abdominal pain, rash, diarrhoea, and muscle spasms.
“These studies investigated the safety and efficacy of elinzanetant for the treatment of moderate to severe hot flashes due to menopause,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health and Lead Investigator on the OASIS 2 trial. “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.”
Claire Gill, President and Founder of the National Menopause Foundation, also welcomed the approval, adding: “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.”
Bayer has confirmed that Lynkuet will be available in the U.S. from November 2025. To ensure access, the company has launched the Lynkuet Access Savings & Support program (LASS), which allows patients to connect with healthcare providers remotely and obtain prescriptions at the most affordable rate available.
Lynkuet is already approved under the same brand name in Australia, Canada, the United Kingdom, and Switzerland, with applications under review in the European Union and additional global markets.
This FDA approval marks a milestone in Bayer’s ongoing commitment to advancing women’s health, particularly in addressing menopausal symptoms that significantly affect quality of life for millions worldwide.
