The U.S. Food and Drug Administration (FDA) has approved Bayer’s Lynkuet (elinzanetant) 60mg capsules for treating moderate to severe hot flashes in menopausal women, marking the first dual neurokinin receptor antagonist to enter the US market.
The once-daily oral treatment works by blocking neurokinin 1 and neurokinin 3 receptors, targeting the brain’s temperature regulation system without using hormones. The approval follows positive results from three Phase III clinical trials involving over 1,400 women.
In the OASIS 1 and OASIS 2 trials with 796 participants, Lynkuet met both primary endpoints, demonstrating significant reductions in the frequency and severity of hot flashes at weeks 4 and 12 compared to placebo. A third trial, OASIS 3, evaluated long-term safety in 627 women for up to 52 weeks.
“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,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health and Lead Investigator on the OASIS 2 trial.
The treatment comes with several safety considerations. Women who are pregnant cannot take Lynkuet, and those who can become pregnant must use effective birth control during treatment and for two weeks after stopping. The drug can cause central nervous system effects including drowsiness, dizziness, and fatigue that may impair driving ability.
Common side effects reported in trials include headache, fatigue, dizziness, drowsiness, abdominal pain, rash, diarrhea, and muscle spasms. Patients require liver function monitoring before starting treatment and at three months, as the drug can increase liver enzymes.
Bayer plans to launch Lynkuet in the United States in November 2025. The company has established the Lynkuet Access Savings & Support program to help patients connect with healthcare providers and receive prescriptions at reduced costs. Eligible patients who cannot afford the medication may receive it at no cost through Bayer’s U.S. Patient Assistance Foundation.
The drug has already received approval in Australia, Canada, the United Kingdom, and Switzerland under the brand name Lynkuet. Regulatory reviews are pending in the European Union and other global markets.
Hot flashes remain one of the primary reasons women seek medical treatment during menopause. These sudden feelings of warmth in the face, neck, and chest, often accompanied by sweating, can significantly disrupt daily activities and sleep patterns.
The approval expands treatment options beyond traditional hormone therapy, providing an alternative for women who cannot or prefer not to use hormonal treatments. The mechanism involves modulating neuronal activity in the brain’s thermoregulation center through antagonism of substance P and neurokinin B signaling.
“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,” said Claire Gill, President and Founder of the National Menopause Foundation.
