A New Hormone-Free Pill Cut Hot Flashes and Improved Sleep in Menopause

CATEGORY: WOMEN’S HEALTH

Fourteen hot flashes a day is about one every waking hour. That was roughly the starting point for 796 menopausal women in two randomized trials, and a once-daily pill containing no hormones cut moderate to severe episodes by about three more a day than placebo within 12 weeks.¹ The pill is elinzanetant, which also improved sleep and menopause-related quality of life in the trials. In October 2025 it became an FDA-approved option for women who cannot take hormone therapy or prefer not to.

Two Matching Trials and a Diary of Every Flash

Researchers ran two identical double-blind trials, OASIS 1 and 2, at 77 sites each across the United States, Canada, Europe and Israel. Women aged 40 to 65 with moderate to severe vasomotor symptoms took part. Vasomotor symptoms are the sudden waves of heat, flushing and sweating better known as hot flashes and night sweats. Allocation to elinzanetant or to an identical-looking placebo was made at random, and neither the women nor their doctors knew which tablet was which. Each woman logged every hot flash in an electronic daily diary, and the trials measured how far the daily count and the severity had shifted by weeks 4 and 12.¹ The drug works on the brain rather than on hormones. When estrogen falls at menopause, a cluster of brain cells involved in temperature control becomes overactive and keeps tripping the body’s heat-release alarm. Elinzanetant blocks two of the chemical signals those cells use, quieting the false alarms. Bayer, which makes the drug, ran and funded the trials, as is standard for new-drug approval studies.

About Three Fewer a Day Than Placebo, From Fourteen

Women began the trials with roughly 13 to 16 moderate or severe hot flashes a day. By week 12, those taking elinzanetant were having about 3.2 fewer episodes a day than those on placebo, and the flashes they did have were milder. Most of that gap had already opened by week 4.¹ The placebo groups improved as well, which is common in hot flash trials. So the fairest measure of the drug is the difference between the groups, not the larger drop each woman saw from her own starting point. Sleep disturbance eased too, and scores on a standard menopause quality-of-life questionnaire were better at week 12.¹

A Year of Use, a Broader Group, a Smaller Gap

A third trial, OASIS-3, followed 628 women for a full year and took in any woman seeking treatment for moderate to severe symptoms, with no minimum number of hot flashes required.² Milder cases were therefore included, and there the gap against placebo at week 12 was smaller: about 1.6 fewer episodes a day. That is a useful caution. The benefit looks largest in women with frequent symptoms. The year of use also carries the safety statement: no liver toxicity, no endometrial hyperplasia, which is a thickening of the uterine lining that can precede cancer, and no meaningful change in bone density. Those are three of the concerns that shadow hormone therapy. Side effects were more common on the drug than on placebo, 30.4% versus 14.6%, most often sleepiness, fatigue and headache.² The researchers framed the whole program around a gap they stated plainly: hormone-free treatments for menopause symptoms were an unmet need, particularly for women advised against hormones, such as breast cancer survivors. Elinzanetant, sold as Lynkuet, is the first approved drug to block both of those brain signals. A related drug blocking one of them, fezolinetant, was approved in 2023.

Key Takeaways

• Elinzanetant cut moderate to severe hot flashes by about three more episodes a day than placebo by week 12 in two randomized trials of 796 menopausal women, from a starting point of roughly 14 a day, with most of the effect present by week 4.
• Sleep and menopause-related quality of life also improved. A year-long companion trial found no liver, uterine-lining or bone safety signals, and sleepiness, fatigue and headache were the most common side effects. That trial admitted women with milder symptoms, and its gap against placebo was smaller, about 1.6 fewer episodes a day.
• The drug was FDA-approved in October 2025 as a hormone-free option, and the trials were funded by Bayer, its maker.

References

1. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials. JAMA. 2024;332(16):1343–1354. link
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 Internal Medicine. 2025;185(11):1319–1327. link