FDA approves Bayer’s Lynkuet as first hormone-free therapy for menopausal hot flashes

This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms

Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Lynkuet (elinzanetant), the first dual neurokinin (NK) targeted therapy—an NK1 and NK3 receptor antagonist—for the treatment of moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause.

This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms. Lynkuet works by inhibiting Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons, modulating neuronal activity involved in thermoregulation and reducing the frequency and severity of hot flashes.

The FDA’s decision is supported by data from three Phase III clinical studies—OASIS 1, OASIS 2, and OASIS 3—that evaluated the efficacy and safety of elinzanetant in women experiencing moderate to severe VMS due to menopause. In the pivotal OASIS 1 and OASIS 2 trials, elinzanetant met all co-primary endpoints, demonstrating significant reductions in both the frequency and severity of hot flashes at weeks 4 and 12 compared to placebo. The safety of elinzanetant was further established in OASIS 3, a long-term study involving 627 women treated for up to 52 weeks.

“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,” saidChristine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer. “There is a need for more individualized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options. This approval reflects our unwavering commitment to delivering science-driven solutions that empower women to take charge of their health at every stage of life.”

Dr. JoAnn Pinkerton, Professor and Director of Midlife Health at UVA Health and Lead Investigator of the OASIS 2 trial, added: “Hot flashes, particularly when severe, can have a profound impact on women’s quality of life. The approval of elinzanetant provides healthcare providers with a new, effective, and well-tolerated option that can be used as a first-line treatment for moderate to severe hot flashes due to menopause.”

Hot flashes are among the most common symptoms of menopause and a primary reason many women seek treatment. These symptoms can vary in intensity and frequency, often disrupting daily activities, sleep, and overall well-being.

Claire Gill, President and Founder of the National Menopause Foundation, stated: “It’s important that women know they have choices for managing moderate to severe hot flashes due to menopause. Today’s approval of Lynkuet expands those options, offering a hormone-free approach supported by strong clinical evidence.”

With the approval of Lynkuet, Bayer continues to advance its long-standing commitment to women’s health by providing innovative and personalized solutions that address unmet needs and improve quality of life during menopause and beyond.