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

CATEGORY: WOMEN’S HEALTH

A once-daily pill that contains no hormones cut moderate to severe hot flashes by about three more episodes a day than placebo within 12 weeks, in two randomized trials of 796 menopausal women who started out averaging roughly 14 hot flashes a day.¹ The pill, elinzanetant, also improved sleep and menopause-related quality of life in the trials, and in October 2025 it became an FDA-approved option for women who cannot take hormone therapy or prefer not to.

Two Identical Trials and an Electronic Hot Flash Diary

Researchers ran two matching double-blind trials, called 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—the sudden waves of heat, flushing, and sweating better known as hot flashes and night sweats—were randomly assigned to elinzanetant or an identical-looking placebo, and neither the women nor their doctors knew who was taking which. Each woman logged every hot flash in an electronic daily diary, and the trials measured how much the daily count and severity changed 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. The trials were run and funded by Bayer, the drug’s maker, which is standard for new-drug approval studies.

About Three Fewer a Day Than Placebo, From Fourteen at the Start

Women in the trials began with roughly 13 to 16 moderate or severe hot flashes a day—about one every waking hour. By week 12, those taking elinzanetant were having about 3.2 fewer episodes a day than those on placebo, and their remaining hot flashes were milder; most of that gap had already opened by week 4.¹ The placebo groups improved too, which is common in hot flash trials, so the fairest measure of the drug is that difference between the groups rather than the larger drop each woman saw from her own starting point. Women taking the drug also reported less disturbed sleep and better scores on a standard menopause quality-of-life questionnaire at week 12.¹

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

A third trial, OASIS-3, followed 628 women for a full year and admitted any woman seeking treatment for moderate to severe symptoms, with no minimum number of hot flashes required—so milder cases were included.² There the gap versus placebo at week 12 was smaller, about 1.6 fewer episodes a day, a useful caution that the benefit looks largest in women with frequent symptoms. The year of use is also the trials’ main safety statement: no liver toxicity, no endometrial hyperplasia (a thickening of the uterine lining that can precede cancer), and no meaningful change in bone density—three 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 stated gap in care: safe, effective, 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 the brain signals involved; a related drug that blocks one of them, fezolinetant, was approved in 2023.

Key Takeaways

• In two randomized trials of 796 menopausal women, elinzanetant cut moderate to severe hot flashes by about three more episodes a day than placebo by week 12, 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, and a year-long companion trial found no liver, uterine-lining, or bone safety signals; sleepiness, fatigue, and headache were the most common side effects.
• In the year-long trial, which included women with milder symptoms, the gap versus placebo was smaller—about 1.6 fewer episodes a day.
• Elinzanetant was FDA-approved in October 2025 as a hormone-free option; 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