The UK has become the first country in the world to approve a non-hormonal treatment for hot flushes and night sweats linked to menopause.
The new drug, called elinzanetant and sold under the brand name Lynkuet, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). Taken once a day as a pill, it provides a new option for women who want relief from menopause symptoms without using hormone-based treatments.
Clinical trials showed that the medication can reduce the number of hot flushes by nearly two-thirds. It may also ease night sweats and improve sleep quality, which are common issues during menopause.
A Non-Hormonal Alternative
Hormone replacement therapy (HRT) is currently the most widely used treatment for menopause symptoms. However, many women are unable or unwilling to use HRT due to potential health risks, including a higher chance of developing certain cancers. Elinzanetant provides a non-hormonal alternative for these women.
According to the MHRA, the drug is the first dual-action, non-hormonal tablet approved to treat both vasomotor symptoms (like hot flushes) and related sleep problems caused by menopause.
How the Drug Works
During menopause, falling oestrogen levels cause some brain cells to become overactive. This disrupts the body’s ability to regulate temperature, leading to hot flushes and night sweats.
Elinzanetant works by calming these brain signals, helping the body regain temperature balance and improve sleep.
The medication is developed by pharmaceutical company Bayer and comes in a simple oral tablet form.
Regulator’s Statement
Julian Beach, interim executive director of healthcare quality and access at the MHRA, welcomed the approval.
“Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life,” he said.
“Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies.”
The MHRA confirmed the drug had met the required standards for safety, quality, and effectiveness, and promised to continue monitoring its safety as more people begin using it.
Clinical Trial Results
Elinzanetant’s approval was based on findings from the Oasis clinical trials, which involved over 1,400 women aged between 40 and 65 across multiple countries.
Participants who took a daily 120mg tablet of elinzanetant saw strong improvements over both short-term and long-term periods:
After 12 weeks: Hot flushes were reduced by about two-thirds.
By week 26: Over 80% of women had at least a 50% drop in hot flush frequency.
Some participants continued to see benefits through 52 weeks, suggesting the drug may provide sustained relief over time.
Rising Demand for Menopause Treatments
The number of women using hormone replacement therapy in the UK has more than doubled in the past five years. Around 2.6 million women are expected to use HRT in 2023-24.
This rise is partly due to increased public awareness, known as the “Davina effect”, after TV presenter Davina McCall spoke openly about her own struggles with menopause and promoted the benefits of HRT.
Earlier fears about HRT stemmed from a major study that overstated the risk of breast cancer. Later reviews showed that those risks had been exaggerated, helping to restore public confidence in hormone therapy.
Still, many women remain cautious, and others are medically advised to avoid hormones—highlighting the importance of safe, effective, non-hormonal options like elinzanetant.
What’s Next?
With the UK leading the way in approving this treatment, elinzanetant could become available in more countries soon. As awareness grows and more women seek options beyond hormones, this new medication may play a key role in reshaping menopause care.
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