The Medicines and Healthcare products Regulatory Agency (MHRA) has today 1 May 2026, approved Linerixibat (Lynavoy) for use to treat an itch in adults with primary biliary cholangitis (PBC).
PBC is a condition where bile ducts in the liver become damaged, leading to a build-up of bile acids in the blood. This build-up is thought to cause itching. Linerixibat helps to reduce the build-up of substances, including bile acids, in the body and so reduce itching.
Linerixibat is administered via an orally ingested film-coated tablet. The recommended dose is one tablet taken twice a day.
A global Phase 3 clinical trial, Glisten, evaluated the safety and effectiveness of linerixibat for treating itching in patients with PBC. In the study, 238 patients were randomly assigned to receive either linerixibat 40 mg twice daily or a placebo for 24 weeks.
The results showed that linerixibat significantly 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 with linerixibat compared with those given placebo.
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, said
“The approval of linerixibat provides a new treatment option for adults with primary biliary cholangitis who experience itching associated with their condition.
“As with all medicines, we will continue to closely monitor the safety and effectiveness of linerixibat as 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 via National 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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