Bayer's First-in-Class Small Molecule Lynkuet (elinzanetant) Receives FDA Approval for Moderate to Severe Menopausal Hot Flashes

(Source:WuXi AppTec）

Source: WuXi AppTec

Bayer announced today that the U.S. FDA has approved Lynkuet (elinzanetant) capsules for marketing, for the treatment of moderate to severe hot flashes associated with menopause (i.e.Vasomotor Symptoms, VMS`) Symptoms.`According to the press release, Lynkuet is the first dual neurokinin (NK) receptor antagonist approved for the treatment of moderate to severe hot flashes.

The FDA approval was primarily based on data from three Phase 3 clinical trials (OASIS-1, OASIS-2, and OASIS-3), which evaluated the safety and efficacy of Lynkuet for treating moderate to severe hot flashes during menopause.

The therapy met all primary endpoints in three studies and demonstrated good safety. In the OASIS-1 and OASIS-2 studies, compared with placebo, Lynkuet significantly reduced the average frequency and severity of moderate to severe VMS associated with menopause at weeks 4 and 12. The efficacy persisted 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.

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, thereby disrupting the body temperature regulation mechanism and causing VMS.LynkuetMay also reduce sleep disturbances associated with menopause.

References:

[1] Bayer’s Lynkuet® (elinzanetant), the First and Only Neurokinin 1 and Neurokinin 3 Receptor Antagonist, Receives FDA Approval for Moderate to Severe Hot Flashes Due to Menopause. Retrieved October 24, 2025 from https://www.businesswire.com/news/home/20251017138908/en/Bayers-Lynkuet-elinzanetant-the-First-and-Only-Neurokinin-1-and-Neurokinin-3-Receptor-Antagonist-Receives-FDA-Approval-for-Moderate-to-Severe-Hot-Flashes-Due-to-Menopause