The U.S. Food and Drug Administration (FDA) has approved Bayer’s elinzanetant, to be marketed as Lynkuet, for the treatment of moderate to severe vasomotor symptoms, commonly known as hot flashes and night sweats, associated with menopause. The once-daily oral therapy is the first FDA-approved drug to block both neurokinin 1 (NK1) and neurokinin 3 (NK3) receptors.
According to Bayer’s announcement, Lynkuet will be available in the United States beginning next month. The medication, presented as a soft gel capsule to be taken at bedtime, is designed to regulate body temperature by targeting two brain receptors linked to hot flash symptoms.
The U.S. approval follows earlier clearances in the United Kingdom, Australia, Canada, and Switzerland, with reviews still ongoing in the European Union and other regions. The FDA’s decision had been delayed earlier this year by up to 90 days to allow additional time for review, though Bayer said no issues were raised about the drug’s “general approvability.”
Lynkuet now joins Astellas’ Veozah, approved in May 2023, and Brisdelle, a nonhormonal therapy cleared in 2013, as one of the few nonhormonal options available in the U.S. for menopause-related hot flashes. Hormone-based treatments remain a long-standing standard, but they are not suitable for all women and are associated with risks such as breast and endometrial cancers.
Bayer stated that up to 80% of women experience hot flashes during menopause, with over one-third reporting severe symptoms that can last for years. The company projects that by 2030, about 1.2 billion women will be in menopause, with 47 million entering this stage annually.
The FDA approval was supported by results from Bayer’s Phase III OASIS development program. In OASIS 1 and OASIS 2, Lynkuet demonstrated statistically significant reductions in both the frequency and severity of vasomotor symptoms compared with placebo at four and twelve weeks. In OASIS 1, vasomotor symptoms fell by 55.9% at week four and 65.2% at week twelve, while OASIS 2 reported reductions of 57.9% and 67% at the same time points. More than 80% of patients achieved at least a 50% reduction in symptom frequency by week 26.
A year-long safety trial, OASIS 3, involving 627 women, confirmed Lynkuet’s favorable safety and sustained efficacy over 52 weeks. The most common side effects included headache, fatigue, dizziness, drowsiness, stomach pain, rash, diarrhea, and muscle spasms. The label also cautions about serious risks such as daytime impairment, elevated liver enzyme levels, potential pregnancy loss, and seizure risk in people with a history of seizures. The drug should not be taken by pregnant women.
In a statement included in Bayer’s announcement, Claire Gill, president and founder of the National Menopause Foundation, said, “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.”
Lynkuet is expected to compete closely with Astellas’ Veozah, which acts only on the NK3 receptor and currently carries a boxed warning for potential liver injury, a warning Lynkuet does not have. Bayer has forecast peak annual sales for Lynkuet of approximately 1 billion euros ($1.16 billion).
In addition to the OASIS 1–3 studies, Bayer conducted OASIS 4 outside the U.S., which evaluated the drug in women with hormone receptor–positive breast cancer on endocrine therapy. The trial also showed significant symptom reduction at weeks 4 and 12 compared to the placebo.
Beyond the immediate FDA approval, Bayer plans to support the rollout of Lynkuet through educational efforts for clinicians and patients about its mechanism of action, which involves blocking the NK1 and NK3 receptors in KNDy (kisspeptin/neurokinin-B/dynorphin) neurons responsible for thermoregulation. Bayer The FDA decision may also influence how insurers cover new non-hormonal therapies and how physicians balance hormone and non-hormone approaches to menopausal symptoms.
Looking ahead, the FDA-approved status of Lynkuet could pave the way for further indications or label expansions, especially in populations such as breast-cancer survivors who are often unable to use hormone therapy. The FDA’s regulatory precedent signals that research into neurokinin-based therapies is gaining traction. As real-world data accumulate, the FDA’s post-market oversight and safety monitoring will be key to how quickly Lynkuet is adopted.
