The Medicines and Healthcare products Regulatory Agency has approved linerixibat, marketed as Lynavoy, for adults with primary biliary cholangitis who experience itching linked to the disease. The authorisation was issued on 1 May 2026 and adds a new licensed treatment option for a symptom that can be persistent and difficult to manage. Primary biliary cholangitis, or PBC, is a liver condition in which the bile ducts become damaged. According to the MHRA announcement, that damage can lead to a build-up of bile acids in the blood, which is thought to contribute to itching.
The approved product is an oral film-coated tablet. The recommended dose set out by the MHRA is one tablet taken twice a day. In practical terms, linerixibat is intended to reduce the build-up of substances in the body, including bile acids, so that itching is reduced. The approval is therefore directed at symptom control in adults with PBC rather than treatment of the underlying liver disease itself.
The evidence cited by the regulator comes from the global Phase 3 Glisten trial. In that study, 238 patients were randomised to receive either linerixibat 40 mg twice daily or placebo over 24 weeks. The MHRA said the results showed a statistically significant improvement in the trial’s main measure, the Monthly Itch Score, for patients treated with linerixibat compared with placebo. The study also found an improvement in sleep disruption caused by itching, which is likely to be clinically relevant for patients whose symptoms affect day-to-day functioning as well as comfort.
Julian Beach, the MHRA’s Interim Executive Director of Healthcare Quality and Access, said the approval gives adults with PBC who experience itching a new treatment option. He also indicated that the regulator will continue to monitor the medicine’s safety and effectiveness as use expands in routine care. That point is central to how medicines regulation works in practice. Approval follows assessment of trial evidence, but oversight continues after launch through post-market surveillance, with regulators looking for any safety issues or usage patterns that only become visible once a medicine is prescribed more widely.
The agency said the full list of side effects will be set out in Section 4 of the Patient Information Leaflet and the Summary of Product Characteristics. Those documents are due to be published on the MHRA products website within seven days of the approval. For prescribers and patients, those texts are the operational documents that govern safe use. They set out the authorised indication, dosing information and known adverse reactions, and they provide the basis for prescribing decisions, dispensing checks and patient counselling.
The MHRA is asking anyone who suspects a side effect from Lynavoy to speak to a doctor, pharmacist or nurse and to report it through the Yellow Card scheme, either online or through the agency’s app. That reporting route is a routine part of UK medicines regulation and is used to identify safety signals that may emerge only after broader real-world use. The approval was granted to GlaxoSmithKline UK Limited through the national procedure, the domestic licensing route administered by the MHRA. As an executive agency of the Department of Health and Social Care, the regulator says its medicines decisions are based on whether a product works and whether the expected benefits justify the risks on the evidence available at the point of authorisation.