MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause
Source: gov.uk (2025-07-07)

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 8 July, become the first regulator in the world to approve elinzanetant (Lynkuet) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause.

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 8 July, become the first regulator in the world to approve elinzanetant (Lynkuet) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause.

When oestrogen levels drop during menopause, certain brain cells become overactive and interrupt the body’s ability to control temperature, which leads to hot flushes and night sweats. Elinzanetant is a new non-hormonal medication which works by calming these signals in the brain, helping bring the body’s temperature control back into balance.

It may also help improve sleep problems that often come with menopause. This medicine is administered in capsule form, to be taken orally.

Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:

“Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life.

“We are therefore pleased to announce our approval of elinzanetant, which has met the MHRA’s standards for safety, quality and effectiveness.

“Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies. As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.”

Elinzanetant’s approval is based on results from the OASIS clinical trials, which involved over 1,400 women aged 40 to 65 across several countries. These studies showed that taking a daily 120 mg capsule of elinzanetant significantly reduced the number and intensity of hot flushes and night sweats over 26 to 52 weeks, compared to a placebo.

Like all medicines, this medicine can cause side effects in some people. A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), available on the MHRA website within 7 days of approval.

Anyone who suspects they are having a side effect from this medicine should talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card (https://yellowcard.mhra.gov.uk/) scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.

Notes to editors

The new marketing authorisation was granted on 8 July 2025 to Bayer plc.

This national approval was granted after an Access Consortium new active substance work-sharing initiative (https://www.gov.uk/guidance/access-new-active-substance-nas-work-sharing-initiative) (NASWSI) procedure.

More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

The MHRA is an executive agency of the Department of Health and Social Care.

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