Commentary|Videos|October 23, 2025

Elinzanetant Demonstrates Rapid and Sustained Efficacy in Reducing Vasomotor Symptoms Across OASIS Clinical Trials

Elinzanetant shows promise as a new treatment for menopause-related vasomotor symptoms, offering rapid relief and a favorable safety profile.

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At the Menopause Society (TMS) 2025 meeting in Orlando, Florida, JoAnn Pinkerton, MD, Professor of Obstetrics and Gynecology at the University of Virginia, discusses the efficacy and safety of elinzanetant, a dual neurokinin-1 and neurokinin-3 receptor antagonist under investigation for the treatment of moderate to severe vasomotor symptoms associated with menopause. Across the phase 3 OASIS 1 and 2 trials, elinzanetant demonstrated significant reductions in the frequency and severity of hot flashes within the first 12 weeks, with improvements observed as early as week 1.

Pharmacy Times: Can you briefly summarize what elinzanetant is and how it works to manage vasomotor symptoms associated with menopause?

JoAnn Pinkerton, MD: Elinzanetant, which will be marketed as Lynkuet if approved, is the first and only dual neurokinin-targeted therapy—an NK1 and NK3 receptor antagonist—under investigation for the treatment of moderate to severe vasomotor symptoms, commonly known as hot flashes and night sweats, due to menopause.

Additionally, 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.

Pharmacy Times: What were the most significant findings regarding elinzanetant’s impact on the frequency and severity of hot flashes in participants?

Pinkerton: So, if we start with OASIS 1 and 2, which were two 26-week, similar clinical trials, the efficacy of elinzanetant for the treatment of moderate to severe hot flashes was demonstrated within the first 12 weeks in both randomized, double-blind, placebo-controlled, multicenter trials.

A total of 796 menopausal women were enrolled across the two studies, and in both, elinzanetant met the co-primary endpoints—showing a reduction in both the number and severity of hot flashes during the day and night. As a secondary endpoint, it also reduced the frequency of moderate to severe hot flashes as early as week 1, which was also observed in OASIS 2, representing an important finding of rapid improvement.

The safety of elinzanetant was evaluated in both the 26-week trials and the 52-week OASIS 3 trial. Across all studies, a total of 1,420 women participated, with more than 600 in OASIS 3 receiving either elinzanetant or placebo for up to 52 weeks, allowing for assessment of long-term safety.

The most frequently reported adverse reactions in OASIS 3, the longer trial, were headache, fatigue, dizziness, and sleepiness or drowsiness. There were also rare elevations in serum transaminases—0.6% in the elinzanetant group and 0.4% in the placebo group—observed during up to 12 weeks of treatment in the clinical trials. No cases of liver toxicity were reported, and these rare events resolved over time or with discontinuation of the medication.

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