FDA Approves Elinzanetant as First Nonhormonal Therapy for Menopause Vasomotor Symptoms

Elinzanetant (Lynkuet; Bayer), the first dual neurokinin 1 and neurokinin 3 receptor antagonist, receives FDA approval for moderate to severe hot flashes due to menopause. Fezolinetant (Veozah; Astellas), a neurokinin 3 receptor antagonist, is Astellas’ hormone-free treatment used to reduce moderate to severe vasomotor symptoms (VMS) due to menopause.Fezolinetant was approved in 2023 as the first hormone-free treatment to reduce moderate to severe vasomotor symptoms (VMS), also known as hot flashes and night sweats, due to menopause.¹

The approval provides a much-needed hormone-free option for women seeking relief from disruptive VMS and represents a new therapeutic class targeting the neurokinin (NK) pathway.¹

Elinzanetant is a dual neurokinin 1 and neurokinin 3 (NK1/NK3) receptor antagonist that acts within the brain’s thermoregulatory center to restore temperature balance disrupted during menopause.¹ This mechanism is distinct from traditional hormone therapies and offers a new pathway for symptom control in women who cannot or prefer not to use estrogen-based options.

The FDA’s approval was supported by results from the phase 3 OASIS 1 (NCT05042362), OASIS 2 (NCT05099159), and OASIS 3 (NCT05030584) clinical trials, which together demonstrated significant and sustained efficacy in reducing both the frequency and severity of hot flashes, as well as improving sleep and overall menopause-related quality of life.^2-4

Data from OASIS 1 and OASIS 2 showed a statistically significant reduction in VMS frequency with elinzanetant compared with placebo from baseline to week 4 and at week 12 in both trials. The treatment also improved VMS severity, sleep disturbances, and health-related quality-of-life scores by week 12, with a favorable safety and tolerability profile.^2,4

Findings from OASIS 3, presented at the 2024 annual meeting of The Menopause Society, reinforced these outcomes, demonstrating durable efficacy and safety over 52 weeks.⁴ Across the trials, elinzanetant was well tolerated, with minimal treatment-emergent adverse events and no significant safety concerns related to liver function or metabolic parameters.^3,4

In an interview with Pharmacy Times, JoAnn Pinkerton, MD, stated that “the inhibition of substance P and neurokinin B through antagonism of the NK1 and NK3 receptor signaling on KNDy (kisspeptin, neurokinin B, dynorphin) neurons modulates neuronal activity involved in thermoregulation, which is associated with the occurrence of hot flashes.” This mechanism directly targets the brain’s thermoregulatory center to stabilize body temperature and reduce the frequency and severity of VMS episodes.⁴

Across the OASIS 1 and OASIS 2 clinical trials, Pinkerton noted that “elinzanetant met the co-primary endpoints—showing a reduction in both the number and severity of hot flashes during the day and night,” with improvements observed “as early as week 1.” Long-term safety data from the OASIS 3 trial further confirmed its tolerability, with the most common adverse reactions being mild, such as headache, fatigue, dizziness, and sleepiness, and no reported cases of liver toxicity.⁴

Following prior regulatory approvals in Australia, Canada, the United Kingdom, and Switzerland, Elinzanetant is expected to be available in the United States beginning in November 2025.¹ The launch underscores Bayer’s commitment to expanding treatment access for women seeking safe, effective, and hormone-free options for menopause symptom management.

REFERENCES

1. Bayer. Lynkuet. Bayer.com. Published October 24, 2025. Accessed October 24, 2025. https://www.bayer.com/en/us/news-stories/lynkuet

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. Published online August 22, 2024. doi:10.1001/jama.2024.14618

3. Clinicaltrials.gov. Published 2025. Accessed October 24, 2025. https://clinicaltrials.gov/study/NCT05030584

4. Pinkerton J, Valletti D. Elinzanetant Demonstrates Rapid and Sustained Efficacy in Reducing Vasomotor Symptoms Across OASIS Clinical Trials. Pharmacytimes.com. Published October 23, 2025. Accessed October 24, 2025. https://www.pharmacytimes.com/view/elinzanetant-demonstrates-rapid-and-sustained-efficacy-in-reducing-vasomotor-symptoms-across-oasis-clinical-trials