An experimental pill called elinzanetant has shown remarkable success in reducing menopause-related hot flashes and night sweats, according to a new clinical trial published in JAMA Internal Medicine.
The study found that women taking the drug experienced a 74% reduction in the frequency and severity of symptoms within three months, with relief lasting for up to a year.
“This yearlong study not only confirmed the initial findings of rapid and significant reduction in the frequency and severity of hot flashes and night sweats but also provided evidence that these effects were sustained over a year, offering hope for longer-term relief,” said study researcher Dr. JoAnn Pinkerton, director of midlife health at University of Virginia Health.
A Non-Hormonal Alternative
Hot flashes and night sweats, medically referred to as vasomotor symptoms, are caused by declining estrogen levels during and after menopause.
While hormone replacement therapy (HRT) is a common treatment, it carries risks such as breast tenderness, bloating, headaches, and, with long-term use, a possible increased risk of stroke or certain cancers.
Elinzanetant contains no estrogen, making it a potential option for women who cannot or choose not to undergo HRT. “The disruptive nature of these bothersome hot flashes can significantly affect women’s daily lives, both at work and at home, underscoring the urgent need for effective non-hormonal treatments,” Pinkerton said.
How the Drug Works
The drug targets estrogen-sensitive receptors in the hypothalamus, the part of the brain that regulates body temperature.
As estrogen levels fall, neurons in this region become hyperactive, disrupting heat regulation and triggering hot flashes. By calming this activity, elinzanetant helps restore balance.
Clinical Trial Results
The trial enrolled 313 postmenopausal women across 83 sites in North America and Europe between August 2021 and February 2024. Participants were randomly assigned either a daily 120 mg elinzanetant pill or a placebo.
Key findings included:
- 74% of elinzanetant patients reported symptom improvement, compared with 47% on placebo.
- Participants reported better sleep and quality of life, though these improvements were not statistically significant.
- Side effects were generally mild, with sleepiness, fatigue, and headache being the most common.
- No harmful effects on liver health or bone density were observed.
Regulatory Status and Next Steps
Despite these encouraging results, the U.S. Food and Drug Administration (FDA) has delayed its decision on approving elinzanetant. In July, the agency told Bayer, the drug’s developer, that it needed more time to review the application.
Dr. Pinkerton emphasized the potential impact:
“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.”
