FDA Approves Elinzanetant, a Hormone-Free Option for Hot Flashes in Menopause

The FDA approved elinzanetant (Lynkuet; Bayer), a nonhormonal treatment for the management of moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause.1

The phase 3 OASIS 1, OASIS 2, and OASIS 3 clinical trials demonstrated elinzanetant’s strong efficacy and favorable safety profile for menopause symptom relief. | Image credit: BHM - stock.adobe.com

Elinzanetant’s approval addresses an unmet need in women’s health care, providing a hormone-free option for VMS relief. The first-in-class neurokinin 1 and neurokinin 3 (NK1/NK3) receptor antagonist works by targeting the root cause of VMS within the brain’s thermoregulatory center—a mechanism of action distinct from traditional hormone replacement therapies.

"Today's approval of elinzanetant is a significant advance for women's health," James A. Simon, MD, medical director and founder of IntimMedicine Specialists and former president of the International Society for the Study of Women’s Sexual Health, told The American Journal of Managed Care®. "First, it's a new option among other options for the treatment of vasomotor symptoms due to menopause—an option that has rapid onset, beneficial effects, very few side effects, and no significant adverse effects as seen with other therapies. It appears to have no adverse effect, for example, on weight or sexual function."

The approval was based on data from the phase 3 OASIS 1 (NCT05042362), OASIS 2 (NCT05099159), and OASIS 3 (NCT05030584) clinical trials. These trials demonstrated elinzanetant’s strong efficacy and favorable safety profile, showing a statistically significant reduction in both the frequency and severity of hot flashes compared with placebo and a favorable safety profile.

Results from OASIS 1 and 2 published in JAMA demonstrated a significant reduction in VMS frequency with elinzanetant vs placebo from baseline to week 4 and at week 12 in both trials.2 In OASIS 1, the mean change in VMS frequency was –3.3 (95% CI, −4.5 to −2.1; P < .001) at week 4 and −3.2 (95% CI, −4.8 to −1.6; P < .001) at week 12. In OASIS 2, the mean change was −3.0 (95% CI, −4.4 to −1.7; P < .001) at week 4 and −3.2 (95% CI, −4.6 to −1.9; P < .001) at week 12.

Elinzanetant also improved VMS severity vs placebo at week 4, with a mean change of −0.3 (95% CI, −0.4 to −0.2; P < .001) in OASIS 1 and −0.2 (95% CI, −0.3 to −0.1; P < .001) in OASIS 2. At week 12, these changes were −0.4 (95% CI, −0.5 to −0.3; P < .001) in OASIS 1 and −0.3 (95% CI, −0.4 to −0.1; P < .001) in OASIS 2. Additionally, elinzanetant improved sleep disturbances and menopause-related quality of life at week 12, and the safety profile was favorable.

Data from OASIS 3 that were presented at the 2024 annual meeting of The Menopause Society further supported its efficacy and safety over 52 weeks.3

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

Following previous approvals in Australia, Canada, the United Kingdom, and Switzerland, the FDA approval paves the way for uptake in the US. It is expected to be available in the US beginning in November 2025.

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. News release. Bayer. October 24, 2025. Accessed October 24, 2025. 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

2. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024;332(16):1343-1354. doi:10.1001/jama.2024.14618

3. 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. News release. Bayer. September 10, 2024. Accessed October 23, 2025. https://www.bayer.com/en/us/news-stories/phase-iii-study-oasis-3