FDA Approves Bayer’s Lynkuet as First Dual Neurokinin Antagonist for Menopausal Hot Flashes

The FDA has approved Bayer’s Lynkuet (elinzanetant) as the first dual neurokinin (NK1 and NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms (VMS), or hot flashes, associated with menopause. The regulatory action gives patients a hormone-free therapeutic option for one of menopause’s most common and disruptive symptoms.¹

Hormone-free therapy offers new approach to managing vasomotor symptoms

Lynkuet is expected to be available in the United States in November 2025.

“It’s important that women know they have choices for treating moderate to severe hot flashes due to menopause, and today’s approval further expands a woman’s options for treating these symptoms,” Claire Gill, president and founder of the National Menopause Foundation, said in a press release.¹

Phase III OASIS trials demonstrate efficacy in reducing hot flash frequency and severity

• Lynkuet is an oral, once daily medication that has been found to modulate estrogen-sensitive neurons in the brain that can cause hyperactivation of the thermoregulatory pathway as estrogen levels decrease, which subsequently impacts body heat control mechanisms and leads to VMS.
• The approval of Lynkuet was based on findings from the Phase III OASIS 1 (NCT05042362), OASIS 2 (NCT05099159), and OASIS 3 (NCT05030584) trials.^2-4
• The multicenter, multinational, double-blind, randomized, placebo-controlled OASIS 1 and 2 trials enrolled postmenopausal individuals aged 40 to 65 years who are experiencing 50 or more moderate to severe VMS symptoms across seven days.
• Across both studies, 309 (78.0%) patients in OASIS 1 and 324 (81.0%) patients in OASIS 2 completed the trial.
• Patients were administered once daily oral Lynkuet at a dose of 120 mg for 26 weeks or matching placebo for 12 weeks followed by Lynkuet 120 mg for 14 weeks.
• Investigators used an electronic hot flash daily diary to measure the trial’s primary endpoints of mean change in frequency and severity of moderate to severe VMS from baseline to weeks four and 12.

Improved sleep and quality of life observed across pivotal studies

• Data published by The Journal of the American Medical Association⁶ showed that Lynkuet significantly lowered VMS frequency at week four (OASIS 1: −3.3 [95% CI, −4.5 to −2.1], P < .001; OASIS 2: −3.0 [95% CI, −4.4 to −1.7], P < .001) and at week 12 (OASIS 1: −3.2 [95% CI, −4.8 to −1.6], P < .001; OASIS 2: −3.2 [95% CI, −4.6 to −1.9], P < .001), while also reducing VMS severity at week four (OASIS 1: −0.3 [95% CI, −0.4 to −0.2], P < .001; OASIS 2: −0.2 [95 CI, −0.3 to −0.1], P < .001) and week 12 (OASIS 1: −0.4 [95% CI, −0.5 to −0.3], P < .001; OASIS 2: −0.3 [95% CI, −0.4 to −0.1], P < .001).
• In addition to improvements in the frequency of severity of hot flashes, Lynkuet was also found to improve sleep disturbances and menopause-related quality of life at week 12.

“These three studies investigated the safety and efficacy of elinzanetant for the treatment of moderate to severe hot flashes due to menopause,” OASIS 2 trial lead lnvestigator JoAnn Pinkerton, MD, professor and director of Midlife Health at UVA Health, said in the release. “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.”¹

References

1. Bayer’s Lynkuet™ (elinzanetant) approved in the U.S. for treatment of moderate to severe vasomotor symptoms due to menopause. News release. Bayer. October 24, 2025. Accessed October 24, 2025. 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/

2. 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 26 Weeks in Women Who Have Been Through the Menopause (OASIS-1). ClinicalTrials.gov. Updated June 27, 2024. Accessed October 24, 2025. https://clinicaltrials.gov/study/NCT05042362

3. 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 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2). ClinicalTrials.gov. May 29, 2024. Accessed October 24, 2025. https://clinicaltrials.gov/study/NCT05099159

4. 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). Updated March 15, 2024. Accessed October 24, 2025. https://clinicaltrials.gov/study/NCT05030584