FDA approves hormone-free menopause drug targeting hot flashes


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Summary

FDA approval

The FDA has approved a new once-a-day, hormone-free pill that treats hot flashes and night sweats in menopausal women.

How it works

The drug works by blocking brain chemicals responsible for hot flashes and night sweats, also known as vasomotor symptoms.

Available soon

The drugmaker, Bayer, says the new drug will be available in the U.S. beginning in November.


Women will soon have a new option when addressing menopausal hot flashes. The U.S. Food and Drug Administration approved a once-a-day, hormone-free pill that treats moderate to severe hot flashes. 

The drug, elinzanetant, will be available in the U.S. beginning in November under the brand name Lynkuet, according to the drugmaker Bayer. 

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“This FDA approval represents a bold step forward – our first hormone-free treatment for alleviating vasomotor symptoms of menopause,” Christine Roth, a spokesperson for Bayer, said in a news release Friday.

Combatting hot flashes

The drug works by blocking brain chemicals responsible for hot flashes and night sweats, also known as vasomotor symptoms. CNN reports it’s estimated that more than 80% of women experience hot flashes during menopause. 

Lynkuet is an alternative option for women who can’t take typical hormone therapy drugs, such as those with certain cancers or underlying conditions. 

“There is a need for more individualized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options,” Roth said.

Bayer conducted three trials on the drug. It found that of 628 postmenopausal women, 73% saw a reduction in the frequency of their vasomotor symptoms after taking the drug for 12 weeks. 

The most common side-effects found in the trial were drowsiness, fatigue and headaches. 

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Why this story matters

The FDA has approved Lynkuet, a hormone-free, once-daily pill for menopausal hot flashes, providing a new treatment option for women who cannot take hormone therapies.

Menopause treatment innovation

The approval of Lynkuet introduces a new, hormone-free alternative for managing menopausal vasomotor symptoms, filling a gap for those unable to use hormone therapy.

FDA approval process

The drug's approval followed clinical trials by Bayer, where over 70% of participants experienced symptom reduction, indicating regulatory confidence in its safety and effectiveness.

Patient access and choice

Lynkuet broadens treatment options for women, especially those with certain health conditions including cancers, who previously had limited safe choices for managing hot flashes.

Straight Arrow
Fear No Fact.

Don't just take our word for it.


Center-rated reporting

According to media bias experts at AllSides

AllSides Center-rated reporting May 2026

Transparent and credible

Awarded a perfect reliability rating from NewsGuard

100/100

Welcome back to trustworthy journalism.

Find out more

Sources

  1. CNN

Bias comparison

  • Media outlets on the left highlight the new menopause drug's non-hormonal aspect, while right-leaning outlets offer a more minimalist announcement, de-emphasizing scientific classification, mechanism of action, or the November availability.
  • Media outlets in the center frame the drug as a "breakthrough" and "novel," providing extensive scientific details and noting its efficacy for both hot flashes and night sweats—a benefit the right de-emphasizes.
  • Not enough unique coverage from media outlets on the right to provide a bias comparison.

Media landscape

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Key points from the Right

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Sources

  1. CNN