JoAnn Pinkerton, MD, highlights long-term safety and efficacy of elinzanetant

The recently published 52-week OASIS-3 trial evaluated the safety and efficacy of elinzanetant, a non-hormonal treatment for vasomotor symptoms (VMS) such as hot flashes and night sweats.^1,2

JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia, explained that participants taking elinzanetant experienced more than a 73% reduction in the frequency and severity of symptoms by week 12. Specifically, the mean number of vasomotor episodes dropped from 6.7 per day in the elinzanetant group to 1.6, compared with a decline from 6.8 to 3.4 in the placebo group. In addition to reducing VMS, patients reported improvements in sleep quality and menopause-related quality of life, though these secondary outcomes require further evaluation to fully understand their scope.

Pinkerton noted that these results build upon the earlier OASIS-1 and OASIS-2 trials, which were 26-week studies involving women with more severe symptoms, often experiencing more than 50 hot flashes per week. In those studies, participants saw rapid improvements within 1 week, with significant reductions at weeks 4 and 12. Notably, 80% of participants achieved at least a 50% reduction in symptoms.

OASIS-3 confirmed that the therapeutic effects of elinzanetant are durable over a longer period, demonstrating sustained symptom control over 52 weeks, with a favorable safety profile and no evidence of liver toxicity. Collectively, the OASIS program strengthens the evidence supporting elinzanetant’s use in a broad population of postmenopausal women.

According to Pinkerton, the availability of non-hormonal options is critical, since up to 80% of women experience VMS during menopause and more than one-third continue to have persistent symptoms that affect work, home life, and overall well-being. For women who cannot take estrogen-based therapies because of contraindications or personal preference, effective non-hormonal treatments are especially important.

Looking ahead, Pinkerton highlighted additional studies of elinzanetant. The OASIS-4 trial, conducted in Europe, focuses on women with breast cancer or those at high risk who are receiving endocrine therapy, such as tamoxifen or aromatase inhibitors. Early findings show that elinzanetant provides rapid and effective symptom relief without new safety concerns, addressing a critical need for this patient group. Additionally, the NIRVANA trial is investigating elinzanetant in postmenopausal women experiencing sleep disturbances, expanding its potential clinical applications.

Pinkerton emphasized that the OASIS program collectively demonstrates elinzanetant’s efficacy, safety, and durability. If approved, it would become the third FDA-approved non-hormonal therapy for menopause symptoms, offering relief not only for vasomotor symptoms but also for sleep and mood disturbances.

Disclosure: Bayer Healthcare Pharmaceuticals Inc.

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