A new nonhormonal drug is showing major promise in easing one of the most disruptive symptoms of menopause.
In a large international clinical trial, the experimental medication elinzanetant reduced hot flashes and night sweats by more than 70% for postmenopausal women.
The study, called OASIS-3, involved more than 600 women between the ages of 40 and 65 across 83 sites in North America and Europe.
Participants were randomly assigned to take either 120 milligrams of elinzanetant or a placebo each day for 52 weeks.
By week 12, women taking elinzanetant experienced a 73% reduction in the frequency and severity of their vasomotor symptoms—hot flashes and night sweats—compared to the placebo group.
These benefits lasted throughout the yearlong study.
Researchers also noted improvements in sleep quality and overall quality of life among women taking the drug, though the trial was not designed to fully measure those outcomes.
Importantly, elinzanetant was not found to harm the liver or bone density, two areas of concern for many treatments. The most common side effects were mild and included fatigue, sleepiness, and headaches.
“Elinzanetant, the first dual neurokinin-1 and neurokinin-3 receptor blocker to finish Phase 3 testing, has shown rapid, significant, and sustained relief of hot flashes and night sweats,” said Dr. JoAnn V. Pinkerton, director of midlife health at UVA Health and senior researcher on the trial.
“These symptoms can severely disrupt daily life and sleep, and for women who cannot or do not want hormone therapy, treatment options have been limited. This drug offers real hope.”
Hot flashes occur because of falling estrogen levels during and after menopause.
Hormone therapy has long been used to replace estrogen, but it is not an option for every woman. Some avoid it due to side effects such as breast tenderness, bloating, or headaches.
Others cannot take it at all because of a history of blood clots, strokes, or hormone-sensitive cancers. Long-term hormone therapy can also carry risks of certain cancers and heart disease.
Elinzanetant contains no estrogen, making it a potentially safer and more widely accessible treatment.
Previous smaller studies, OASIS-1 and OASIS-2, had shown positive results, but OASIS-3 was the largest and longest test so far, confirming its effectiveness and safety across a broad population of women.
The drug has also shown benefits in women who experience hot flashes as a side effect of breast cancer treatments, according to the OASIS-4 trial.
Before it becomes available to patients, elinzanetant must be approved by the U.S. Food and Drug Administration.
The agency delayed its decision earlier this year to allow more time for reviewing the company’s application. Still, researchers say the evidence so far suggests elinzanetant could soon provide millions of women with a much-needed new option for relief from menopause symptoms.
