OASIS-3 highlights safety and efficacy of elinzanetant against VMS

OASIS-3 highlights safety and efficacy of elinzanetant against VMS | Image Credit: © Rido – © Rido – stock.adobe.com.

The OASIS-3 trial, published in JAMA Internal Medicine, has highlighted the efficacy of elinzanetant for significantly reducing vasomotor symptoms (VMS) such as hot flashes and night sweats in postmenopausal women.¹

Results of the international clinical trial indicated a 73% reduction in the frequency and severity of VMS by week 12. Additionally, reduced sleep disturbances and improved quality of life were reported in participants taking elinzanetant. There were no adverse liver or bone density outcomes linked to the investigational drug.

“The disruptive nature of these bothersome hot flashes, particularly when they are more severe, can significantly affect women’s daily lives, both at work and at home, underscoring the urgent need for effective non-hormonal treatments,” said JoAnn V. Pinkerton, MD, director of midlife health at UVA Health.

Treatment regimen and follow-up

The OASIS-3 trial was conducted to assess elinzanetant’s effects against VMS beyond 6 months of use in postmenopausal women.² Participants included postmenopausal women aged 40 to 65 years seeking moderate to severe VMS treatment. Those with abnormal liver parameters, hyperplasia, or other certain disorders were excluded from the analysis.

After randomization, participants received a 52-week regimen of either elinzanetant 120 mg or a matching placebo. The drug was taken once per day orally, with visits performed every 4 weeks until week 12, then every 6 weeks until week 42. Additional visits included an end-of-treatment visit at week 52 and follow-up after 4 weeks.

Investigators recorded the mean change in moderate to severe VMS frequency between baseline and week 12 as the primary outcome. This outcome was based on data from an electronic hot flash daily diary, which was collected for the final time at weeks 49 and 50.

Mean changes in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form and Menopause-Specific Quality Of Life (MENQOL) questionnaire scores across 52 weeks were reported as secondary outcomes. Participants also reported instances of adverse events (AEs), with intensity and relatedness to the intervention recorded by investigators.

Key efficacy findings

There were 628 women aged a mean of 54.7 years included in the final analysis, 49.8% of whom received elinzanetant and 50.2% received placebo. Similar baseline demographics were reported between patients receiving elinzanetant vs placebo, including the number of participants taking prohibited medication in each group.

Moderate to severe VMS events were reported an average of 6.7 times per day in the elinzanetant group vs 6.8 in the placebo group at baseline. By week 12, mean percentage changes in VMS events were -73.8% and -47%, respectively, with a mean 1.4 and 3.5 events, respectively, reported by week 50.

For moderate to severe severity between baseline and week 12, mean changes of -1.2 and -0.8, respectively, were reported. Additionally, declines in mean Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form were -9.4 and -5.7, respectively, with scores of 57.4 and 58, respectively, at baseline.

Safety profile and adverse events

MENQOL scores were 4.1 and 4.4, respectively, at baseline, with reductions of -1.3 and -1.1 by week 50. Treatment-emergent AEs (TEAEs) were reported in 70% of patients receiving elinzanetant vs 61.1% receiving placebo. Of these, 89.5% and 89.6%, respectively, were mild or moderate.

Rates of serious TEAEs were 4.2% and 1.9%, respectively. However, none of these events were considered treatment-related. Overall, the data highlighted safety and efficacy for elinzanetant toward reducing moderate to severe VMS in postmenopausal women.

“What is so exciting is that with elinzanetant, we potentially have a new treatment option that can be used first-line for moderate to severe hot flashes, whether due to menopause or breast cancer endocrine therapy,” said Pinkerton.¹

References

1. Menopause drug reduces hot flashes by more than 70%, international clinical trial finds. University of Virginia Health System. September 18, 2025. Accessed September 23, 2025. https://www.eurekalert.org/news-releases/1098754.
2. Panay N, Joffe H, Maki PM, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: a phase 3 randomized clinical trial. JAMA Intern Med. 2025. doi:10.1001/jamainternmed.2025.4421