LONDON, May 1 -- The government of the United Kingdom issued the following news:

The Medicines and Healthcare products Regulatory Agency (MHRA) has today 1 May 2026, approved Linerixibat(Lynavoy) for use to treat an itch in adults withprimary biliary cholangitis (PBC).

PBC is a condition where bile ducts in the liver become damaged, leading to abuild-upof bile acids in the blood. This build-up is thought to cause itching.Linerixibathelps to reduce the build-up of substances, including bile acids, in the bodyand so reduce itching.

Linerixibatis administeredviaan orally ingestedfilm-coated tablet. The recommended dose is one tablet taken twice a day.

A global Phase 3 clinical trial,Glisten,evaluated the safety and effectiveness oflinerixibatfor treating itching in patients with PBC. In the study, 238 patients were randomly assigned to receive eitherlinerixibat40 mg twice daily or a placebo for 24 weeks.

The results showed thatlinerixibatsignificantly reduced itching and improved sleep disruption caused by itching. The study's main measure, the Monthly Itch Score, showed a statistically significant improvement in patients treated withlinerixibatcompared with those given placebo.

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

"The approval oflinerixibatprovides a new treatment option for adults with primary biliary cholangitiswho experience itching associated with their condition.

"As with all medicines, we will continue to closely monitor the safety and effectiveness oflinerixibatas it is used more widely."

For the full list of all side effects reported with this medicine, see Section 4 of the PIL or the SmPC available on the MHRA website.

Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it to the Yellow Card 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  

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The approval was granted on 01/05/2026 to GlaxoSmithKline UK Limited

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This product was submitted and approved viaNational Procedure

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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.  

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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.  

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

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For media enquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.

Disclaimer: Curated by HT Syndication.