Written By: Shreya Bendsure, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has approved Lynkuet (elinzanetant) 60 mg capsules for the treatment of moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes and night sweats, due to menopause in adult women. The marketing authorization holder is Bayer, a global pharmaceutical leader, which will commercialize the drug in the United States beginning in November 2025.
About Lynkuet
Lynkuet contains elinzanetant, a new type of oral medicine that blocks two specific receptors in the brain called neurokinin-1 (NK1) and neurokinin-3 (NK3). These receptors control body temperature in a part of the brain known as the hypothalamus. During menopause, lower estrogen levels disrupt this temperature control, causing hot flashes and night sweats. Elinzanetant works by stopping the action of neurokinin B and substance P, two molecules that bind to these receptors and trigger symptoms. Dual NK1/NK3 antagonism is proposed to broaden the mechanism of action; OASIS results show strong efficacy, but direct head-to-head comparisons with other agents have not been reported. This dual blockade also helps improve sleep and mood, contributing to better overall symptom management.
About Vasomotor Symptoms in Menopause in Women
Vasomotor symptoms affect about 80% of women going through menopause. These symptoms, which include hot flashes and night sweats, can be moderate to severe and greatly reduce quality of life by disturbing sleep and daily activities. On average, these symptoms last around 7.4 years, but some women may experience them for over 10 years. Hot flashes cause sudden intense feelings of heat along with sweating, flushing, and sometimes a fast heartbeat, often followed by chills. Night sweats are similar hot flashes that happen during sleep and frequently disrupt rest, causing tiredness and difficulty concentrating. While hormone therapy is the most effective treatment, it cannot be used by women with certain health risks such as hormone-sensitive cancers or blood clots, creating a need for safe non-hormonal options. Studies also show that Black women experience these symptoms more often and severely, highlighting the need for accessible treatments for all groups.
Clinical Evidence
The FDA approval of Lynkuet was primarily based on data from the phase 3 OASIS clinical trial program, including OASIS-1, OASIS-2, and OASIS-3, which collectively demonstrated consistent efficacy and safety. The OASIS-3 trial (NCT05030584) a pivotal randomized, double-blind, placebo-controlled study, evaluated elinzanetant 60 mg once daily in postmenopausal women with moderate to severe Vasomotor Symptoms (VMS). The co-primary endpoints were the mean change from baseline in the frequency and severity of moderate to severe VMS at weeks 4 and 12.
Results showed that by week 12, participants receiving elinzanetant had ≳73% reduction in moderate-to-severe VMS frequency versus ≈47% with placebo (co-primary endpoints were VMS frequency and severity at weeks 4 and 12). This significant reduction was evident as early as week 1 and sustained through the treatment period. Secondary endpoints included improvements in sleep quality, measured by the Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI), and menopause-specific quality of life (MenQoL-I) scores, all of which showed statistically significant benefits with elinzanetant versus placebo. The efficacy observed in OASIS-3 was consistent with the earlier OASIS-1 (NCT05042362) and OASIS-2 trials (NCT05099159), confirming the robustness of the treatment effect across diverse populations.
Safety Profile
Lynkuet showed a good safety record in the OASIS clinical trials. Most side effects were mild to moderate and included headache, trouble sleeping, and high blood pressure, reported in at least 2% of patients and more often than with placebo. Unlike another similar drug, Veozah (fezolinetant), no cases of clinically apparent drug-induced liver injury were seen in the OASIS studies. There were no cases of liver injury or significant liver enzyme increases that made patients stop treatment. Lynkuet also did not cause weight gain or harm sexual function, which can be problems with some menopause medicines. Long-term data from up to 52 weeks confirmed Lynkuet remains well tolerated with no new safety concerns. Overall, this safety profile supports Lynkuet as a favorable option for women seeking non-hormonal treatment for menopausal hot flashes and night sweats.
Key Opinions
Christine Roth, Executive Vice President of Global Product Strategy and Commercialization at Bayer, stated, “This FDA approval represents a bold step forward our first hormone-free treatment for alleviating vasomotor symptoms of menopause. There is a need for more personalized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options”.
Dr. JoAnn Pinkerton, Professor and Director of Midlife Health at UVA Health and a lead investigator in the OASIS-2 trial, emphasized the clinical impact: “Hot flashes, particularly when severe, can have an impact on women’s daily lives and this approval provides healthcare providers with a new treatment option that can be used first line for moderate to severe hot flashes due to menopause”. She further noted, “We think that there’s a benefit from targeting two receptors. We saw a very rapid reduction in hot flashes and night sweats similar to Veozah, and an improvement in the severity of the hot flashes, as well as an improvement in health-related quality of life and sleep”.
Dr. James A. Simon, a leading menopause expert, added, “Today’s approval of elinzanetant is a significant advance for women’s health. It’s a new option that has rapid onset, beneficial effects, very few side effects, and no significant adverse effects as seen with other therapies”
Public Health Implications
The approval of Lynkuet is an important development in women’s health, providing a new non-hormonal option for treating moderate to severe hot flashes during menopause. Lynkuet works differently than other medicines because it targets two pathways in the brain important for controlling body temperature and sleep.
With a good safety profile and no warnings about liver injury, Lynkuet may be safer than similar drugs already on the market. The approval signals more attention and research in menopause care, which has often been overlooked. Ongoing studies are also looking at Lynkuet for women with breast cancer and sleep problems, which could widen its use. Having a new, effective, and well-tolerated medicine like Lynkuet can improve everyday life for many women facing menopause symptoms.
References
Data from Phase III study OASIS 3 support efficacy and long-term safety of investigational compound elinzanetant in the treatment of moderate to severe vasomotor symptoms associated with menopause, Bayer, 10 Sept 2024, https://www.bayer.com/en/us/news-stories/phase-iii-study-oasis-3
Panay N et al, Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial. JAMA Intern Med. 2025 Sep 8:e254421. doi: 10.1001/jamainternmed.2025.4421. Epub ahead of print. PMID: 40920404; PMCID: PMC12418220.
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause (OASIS-3), ClinicalTrials.gov ID NCT05030584, https://clinicaltrials.gov/study/NCT05030584
Nappi RE, et al, Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause. 2021 May 24; 28(8):875-882. Doi: 10.1097/GME.0000000000001793. Erratum in: Menopause. 2022 Jun 01;29(6):759. Doi: 10.1097/GME.0000000000001996. PMID: 34033602; PMCID: PMC8746897.
Bayer’s Lynkuet™ (elinzanetant) approved in the U.S. for treatment of moderate to severe vasomotor symptoms due to menopause, 24 October 2025, Bayer, https://www.bayer.com/media/en-us/bayers-lynkuet-elinzanetant-approved-in-the-us-for-treatment-of-moderate-to-severe-vasomotor-symptoms-due-to-menopause/