• Posted September 25, 2025

New Pill Treats Menopause Hot Flashes Without Hormones

An experimental pill can significantly reduce hot flashes and night sweats for women after menopause, a new clinical trial has determined.

Elinzanetant produced a nearly 74% reduction in the frequency and severity of these menopause symptoms within three months, researchers reported recently in JAMA Internal Medicine.

Further, this relief lasted for a year, the trial found.

“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,” researcher Dr. JoAnn Pinkerton said in a news release. She’s director of midlife health at University of Virginia Health in Richmond.

Hot flashes and night sweats are caused by the natural decrease in estrogen levels during and after menopause. Doctors refer to these as “vasomotor symptoms.”

Hormone replacement therapy can treat these symptoms, but the treatment can come with side effects like breast tenderness, bloating, headaches and spotting, researchers said. Long-term hormone therapy also might increase risk of stroke or certain cancers.

“For those dealing with moderate to severe vasomotor symptoms due to menopause, the treatment options have been limited, especially for those who cannot or choose not to undergo hormone therapy,” Pinkerton said.

“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," she added.

Elinzanetant contains no estrogen, so it could offer an important new option for women who can’t or don’t want to use hormone therapy, researchers said.

Elinzanetant works by targeting estrogen-sensitive receptors in the hypothalamus, researchers said. As estrogen levels decline, these neurons become hyperactive and disrupt the proper regulation of a woman’s body heat.

The clinical trial involved 313 postmenopausal women recruited at 83 sites in North America and Europe between August 2021 and February 2024.

Participants were randomly prescribed either a 120 mg elinzanetant pill taken daily or a placebo.

Results showed that the drug effectively reduced hot flashes, with nearly 74% of elinzanetant patients showing improvement versus 47% of placebo patients.

Participants also had better sleep and improved quality of life, but those results were not statistically significant.

The drug’s most common side effects were sleepiness, fatigue and headache. It had no harmful effects on women’s liver health or bone density, researchers concluded.

“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,” Pinkerton said.

The U.S. Food and Drug Administration (FDA) in July delayed its decision on elinzanetant, telling the drug’s developer, Bayer, that more time was needed to review the company’s application.

Bayer funded the clinical trial. 

More information

The Menopause Society has more on menopause symptoms.

SOURCES: University of Virginia, news release, Sept. 18, 2025; JAMA Internal Medicine, Sept. 18, 2025