Bayer has announced the FDA approval of Lynkuet (elinzanetant), the first dual neurokinin (NK1 and NK3) receptor antagonist, for the treatment of moderate to severe hot flashes due to menopause.
The therapy was first approved in the UK in July, followed by approvals in Australia, Switzerland and Canada.
Lynkuet is the first treatment to target both NK1 and NK3 receptors in the brain, aiming to dampen the neural signaling that contributes to vasomotor symptoms (i.e., hot flashes).
Lynkuet acts on a specialized network in the hypothalamus known as kisspeptin/neurokinin B/dynorphin (KNDy) neurons. Blockade of the NK1 and NK3 receptors on KNDy neurons prevents the binding of the peptides Substance P and Neurokinin B, thereby modulating neuronal activity associated with thermoregulation during hot flashes.
With the approval, Lynkuet is now the third approved nonhormonal therapy for the treatment of menopause symptoms. It will be going up against Astellas’ Veozah (fezolinetant), a nonhormonal menopause symptom drug that targets NK3 but not NK1. Veozah received FDA approval in May 2023.
Brisdelle (paroxetine) is the third nonhormonal treatment on the market in the US to treat menopause associated hot flashes. Cleared in 2013, the drug is a reformulation of an older generation antidepressant.
Hot flashes, or vasomotor symptoms, are one of the most common and disruptive manifestations of menopause. For many women, they interfere with daily life, sleep, mood and quality of life.
Up to 80% of women experience hot flashes during the menopausal transition, making them one of the primary reasons women seek treatment. More than one-third report severe vasomotor symptoms, which can persist for a decade or longer after the final menstrual period, according to Bayer.
By 2030, Bayer estimates that 1.2 billion women worldwide will be experiencing menopause, with 47 million women entering this stage of life each year.
Related: Gates Foundation Pledges $2.5B to Advance Innovations in Women’s Health Worldwide
Hormone therapy involving the use of estrogen alone or in combination with progesterone has long been a standard treatment for vasomotor symptoms. However, hormone-based therapies are not suitable for all women and carry known risks, including endometrial and breast cancers.
“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. 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,” said Yesmean Wahdan, MD, Head of Medical Affairs USA & North America at Bayer.
Lynkuet is formulated as 60 mg soft gel capsules, to be taken once daily at bedtime, with or without food.
Lynkuet’s efficacy in reducing moderate to severe hot flashes was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS 1 and OASIS 2, in 796 menopausal women.
In the OASIS 1 and OASIS 2 trials, Lynkuet significantly reduced the average frequency and severity of moderate to severe hot flashes compared with placebo at both four and 12 weeks. By Week 26, over 80% of participants receiving Lynkuet experienced at least a 50% reduction in vasomotor symptoms.
The studies also demonstrated statistically significant improvements in sleep disturbances and overall menopause-related quality of life compared with placebo, according to Bayer.
The safety of Lynkuet was evaluated in the two trials and in a third trial, OASIS 3, totalling 1,420 women across the three trials. In OASIS 3, 627 women received Lynkuet or placebo for up to 52 weeks to evaluate long-term safety.
XTALKS WEBINAR: Harnessing the Power of Real-World Data for New Therapies
Live and On-Demand: Thursday, November 13, 2025, at 1pm EST (10am PST)
Register for this free webinar to gain insight into opportunities for evaluating and leveraging RWD sources, including EHR unstructured clinical notes, to support business decisions surrounding a new therapy launch.
Lynkuet is expected to become available in the US starting November 2025.
Bayer will roll out a program called Lynkuet Access Savings & Support (LASS), aiming to help patients access the medication affordably. For qualifying patients, Bayer’s US Patient Assistance Foundation may provide the drug at no cost.
Lynkuet may have the advantage over Astellas’ Veozah in terms of safety/perceived safety, as Veozah currently carries a black box warning for potential liver damage, whereas Lynkuet does not. The FDA added the warning in December 2024 following reports of elevated liver function tests and symptoms of liver injury in a patient who had been on the medication for about 40 days.
Bayer has cautioned about some of Lynkuet’s potential serious side effects, including daytime impairment, elevated liver enzymes, risk of pregnancy loss and potential seizures in individuals with a history of seizure disorders. The company emphasized that the drug should not be used during pregnancy.
Bayer’s FDA approval comes after a short delay earlier this year, when the agency pushed back its target decision date by up to 90 days. Bayer said the extension reflected the FDA’s need for additional review and emphasized that no concerns had been raised about Lynkuet’s overall approvability.
Bayer has projected that annual peak sales of the drug could hit around €1 billion ($1.16 billion).
Meanwhile, Veozah fell short of Astellas’ expectations in 2024. During the Japanese fiscal year, the NK3 receptor antagonist generated sales of 33.8 billion yen (approximately $221.25 million), below the company’s projections. Earlier this year, Astellas forecasted that fiscal 2025 sales could reach 50 billion yen ($327.3 million).
Lynkuet is currently under review or pending in other markets, including the European Union (EU).
Join or login to leave a comment
JOIN LOGIN