Bayer's First-in-Class Dual Neurokinin Receptor Antagonist Lynkuet (Elinzanetant) Receives First Global Approval for Menopausal Vasomotor Symptoms

▎WuXiKant

Bayer recently announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Lynkuet (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.According to the press release, Lynkuet is the first approved dual neurokinin (NK) targeted therapy.The therapy's marketing application is also under review by regulatory authorities in the United States and the European Union.

The approval of Lynkuet is primarily based on its positive efficacy and favorable safety profile demonstrated in the Phase 3 clinical studies OASIS-1, -2, and -3. The therapy achieved all primary endpoints across the three studies and exhibited a good safety profile. In the OASIS-1 and OASIS-2 studies, compared to placebo, Lynkuet significantly reduced the average frequency and severity of moderate to severe VMS associated with menopause at Week 4 and Week 12. The efficacy was sustained up to Week 26.More than 80% of subjects in the Lynkuet group experienced a reduction in VMS frequency of at least 50%, including those who switched from placebo to Lynkuet after week 12.The two studies also met three key secondary endpoints, including a significant reduction in VMS frequency from baseline to Week 1, as well as statistically significant improvements compared to placebo in sleep disturbance and menopause-related quality of life.

In the OASIS-3 study, Lynkuet significantly reduced the average frequency of moderate to severe VMS at week 12 compared to placebo, and this efficacy was maintained throughout the study period.OASIS-3 further confirmed the findings of OASIS-1 and OASIS-2, demonstrating the sustained efficacy and safety of the therapy over 52 weeks.The most frequently reported adverse reactions in the Lynkuet group were headache, fatigue, and drowsiness.

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LynkuetIt is a "first-in-class" dual neurokinin-1,3 (NK-1,3) receptor antagonist, administered orally once daily, and represents a non-hormonal therapy for treating moderate to severe VMS associated with menopause.This therapyBy regulating a group of estrogen-sensitive neurons (KNDy neurons) in the hypothalamus region of the brain to treat VMS. These neurons become hypertrophic as estrogen levels decrease, leading to overactivation of the thermoregulatory pathway, which disrupts the body's temperature control mechanism, resulting in VMS.LynkuetMay also reduce sleep disturbances associated with menopause.

By 2030, the number of women worldwide experiencing menopause is expected to increase to 1.2 billion, with 47 million entering this phase each year. Menopause is a transitional stage in a woman's life associated with the gradual decline of ovarian function, typically occurring in women in their 40s or early 50s. The decrease in hormones can lead to various symptoms, including vasomotor symptoms (VMS), sleep disturbances, and mood changes, all of which can significantly impact women’s health, quality of life, and work productivity. Effectively addressing these symptoms is crucial for maintaining normal function and quality of life during menopause.

References:

[1] MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause. Retrieved July 11, 2025 from https://www.gov.uk/government/news/mhra-approves-elinzanetant-to-treat-moderate-to-severe-vasomotor-symptoms-hot-flushes-caused-by-menopause

[2] Bayer receives first approval worldwide for Lynkuet™ (elinzanetant) in the UK as treatment of moderate to severe vasomotor symptoms associated with menopause. Retrieved July 11, 2025 from https://www.bayer.com/media/en-us/bayer-receives-first-approval-worldwide-for-lynkuet-elinzanetant-in-the-uk-as-treatment-of-moderate-to-severe-vasomotor-symptoms-associated-with-menopause/

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