New pill reduces menopause hot flashes by 73% without hormones

Menopause can turn daily life into a stop and start of heat, sweat, and poor sleep. These are the hot flashes and night sweats that unsettle temperature control and sleep.

For many, hormone therapy works, but not everyone supports this approach.

Researchers have now tested a nonhormonal pill called elinzanetant to see if it could ease the vasomotor symptoms of menopause, without bringing estrogen back into the mix.

Effects of the menopause pill

The OASIS program tracked whether a once daily capsule could reduce the number and intensity of hot flashes and night sweats over a full year. It also followed safety signals with repeated checks on the liver, bones, and the uterine lining.

The work was led in part by JoAnn V. Pinkerton, M.D., at UVA Health. Her team and collaborators ran sites across North America and Europe.

“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 Pinkerton.

Who took part and what changed

In the 52 week OASIS 3 trial, 628 postmenopausal women were randomly assigned to elinzanetant or placebo.

By week 12, the elinzanetant group showed a 73.8 percent drop in moderate to severe hot flashes compared with 47.0 percent on placebo.

By week 50, women on elinzanetant averaged 1.4 moderate to severe episodes per day versus the 3.5 episodes in those on placebo. Those numbers lined up with earlier, shorter trials.

Safety monitoring found no signals of liver injury, endometrial thickening, or bone loss across a year.

Treatment-related side effects were more frequent with the drug than with the placebo. These included sleepiness, fatigue, and headache, and most were mild to moderate.

How the menopause pill works

Elinzanetant blocks two signaling switches in the brain called neurokinin 1 (NK 1) and neurokinin 3 (NK 3) receptors.

These switches sit on a small network of KNDy neurons in the hypothalamus that helps manage heat balance and sleep.

When estrogen falls in midlife, those neurons fire more often and send stronger signals. The result is a burst of blood vessel dilation, heat, and sweat, followed by chills.

By dampening both NK 1 and NK 3 signaling, the menopause pill targets the engine room behind symptoms. It is taken by mouth once a day, without adding hormones.

Why this matters for safety

A nonhormonal option gives clinicians a tool for people with medical reasons to avoid estrogen, including some with a history of blood clots or hormone-sensitive cancers. It also gives a choice to those who prefer to skip hormones for personal reasons.

Across a year, study teams tracked lab values and imaging designed to catch rare harms early. The absence of liver toxicity and the stable bone measures are reassuring for a medication designed for long-term use.

Approvals outside the United States

The U.K. regulator issued the first approval in 2025 and assigned the brand name Lynkuet. The announcement noted the nonhormonal mechanism and the capsule dosing.

Health Canada granted a Notice of Compliance, recorded in its drug product database. The listing shows the product name Lynkuet and the status as approved.

Meaning for breast cancer care

Hot flashes that are driven by endocrine therapy can be intense and persistent. That makes adherence hard for some patients who could benefit from staying on their cancer treatment.

A separate phase 3 paper in the New England Journal of Medicine studied women on endocrine therapy for hormone receptor-positive breast cancer or its prevention. At week 12, elinzanetant reduced daily moderate to severe episodes by 7.8 from baseline versus 4.2 with placebo. Common side effects were headache, fatigue, and sleepiness.

These results point to a path where oncologists and menopause specialists can coordinate care. A single, daily, nonhormonal pill could lower symptom burden without stepping on the benefits of cancer therapy.

Menopause pill versus existing options

Hormone therapy is effective for many and remains a mainstay for healthy candidates. It delivers fast relief but is not right for everyone.

Several nonhormonal medicines are already used in clinics, including certain antidepressants and neuroactive drugs. Their benefits vary, and some have side effects that lead people to stop early.

Elinzanetant aims at the brain circuit that starts hot flashes rather than downstream effects. That direct approach may explain the speed and size of the response seen by week 12.

What to watch next

In the United States, the FDA review was extended by up to 90 days in July 2025. The company expects a final decision after the extended timeline.

Real world use in the U.K. and Canada will provide early safety and adherence data. That post approval experience often shapes prescribing patterns and insurance coverage.

Researchers are also testing whether the menopause pill can ease night symptoms and lift sleep quality and daytime function. Those secondary outcomes will need dedicated trials in order to make the necessary measurements.

The study is published in JAMA Internal Medicine.

—–

Like what you read? Subscribe to our newsletter for engaging articles, exclusive content, and the latest updates. 

Check us out on EarthSnap, a free app brought to you by Eric Ralls and Earth.com.

—–