The US Food and Drug Administration (FDA) has approved Bayer’s elinzanetant, under the brand name Lynkuet, as the first dual neurokinin (NK) receptor antagonist therapy for the treatment of moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause.
Elinzanetant acts as a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist. By inhibiting Substance P and Neurokinin B signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons, the drug helps regulate neuronal activity involved in thermoregulation, a mechanism linked to hot flashes.
The FDA approval is based on data from three Phase III clinical studies—OASIS 1, OASIS 2, and OASIS 3—evaluating the efficacy and safety of elinzanetant in women with moderate to severe VMS.
In the OASIS 1 and OASIS 2 trials, involving 796 participants, elinzanetant demonstrated significant reductions in the frequency and severity of hot flashes over 12 weeks compared to placebo. The OASIS 3 trial, which included 627 women treated for up to 52 weeks, supported the long-term safety profile of the drug.
Dr. JoAnn Pinkerton, Professor and Director of Midlife Health at UVA Health and Lead Investigator of the OASIS 2 trial, noted that the studies provided evidence supporting elinzanetant as a new treatment option for women experiencing moderate to severe menopausal hot flashes.
According to Bayer, Lynkuet represents the company’s first hormone-free therapy for managing menopausal symptoms. The medication is expected to be available in the United States beginning November 2025.
Elinzanetant has also received regulatory approval in Australia, Canada, the United Kingdom, and Switzerland, with reviews ongoing in the European Union and other markets.
Menopause, typically occurring in women in their 40s or 50s, is associated with declining estrogen levels that can lead to hot flashes, sleep disturbances, and mood changes. By 2030, an estimated 1.2 billion women globally are expected to be in the menopausal phase, with 47 million entering it each year.
Bayer continues to expand its women’s health portfolio, which includes therapies for contraception, menopause management, and gynecological conditions. The company aims to improve access to reproductive health solutions in low- and middle-income countries as part of its broader sustainability and global health initiatives.
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