The Medicines and Healthcare products Regulatory Agency has approved linerixibat, marketed as Lynavoy, for the treatment of itch in adults with primary biliary cholangitis. The decision was announced on 1 May 2026 and gives patients with this complication of PBC access to a newly authorised medicine in the UK regulatory system. According to the MHRA, the approval was granted to GlaxoSmithKline UK Limited through the national procedure. The agency said the medicine adds a further treatment option for adults whose disease is associated with persistent itching, a symptom that can carry a significant burden for day-to-day wellbeing.
Primary biliary cholangitis is a chronic liver disease in which the bile ducts become damaged. As described in the government announcement, that damage can lead to a build-up of bile acids in the blood, which is thought to contribute to itching. In practical terms, the approval matters because pruritus in PBC is not a marginal symptom. It can affect sleep, concentration and quality of life, so a medicine aimed directly at itch may alter how the condition is managed in routine care for some patients, even where underlying liver disease remains the wider clinical focus.
The MHRA said linerixibat works by reducing the build-up of substances in the body, including bile acids, and in turn reducing itching. The product is supplied as an orally administered film-coated tablet, with the recommended dose set at one tablet twice daily. That dosing schedule is a relevant detail for prescribers and patients because it places the medicine within a standard outpatient treatment model rather than a hospital-based intervention. For health services, this means implementation is likely to depend less on delivery infrastructure and more on prescribing guidance, patient selection and follow-up.
The evidence cited by the regulator comes from Glisten, a global Phase 3 clinical trial assessing the safety and effectiveness of linerixibat for itching in patients with PBC. In that study, 238 patients were randomly assigned to receive either linerixibat 40 mg twice daily or placebo over 24 weeks. The MHRA reported that the trial showed a statistically significant reduction in itching among patients treated with linerixibat when compared with placebo. The main study endpoint, the Monthly Itch Score, improved to a statistically significant degree, and the agency also said the treatment improved sleep disruption caused by itching.
For regulatory readers, the decision is notable because it rests on both symptom control and patient-reported impact. The reference to sleep disruption indicates that the assessment was not confined to a narrow clinical measure, but also considered how the symptom affects daily functioning. Julian Beach, the MHRA's Interim Executive Director of Healthcare Quality and Access, said the approval provides a new treatment option for adults with primary biliary cholangitis who experience itching associated with their condition. He also said the agency would continue to monitor the medicine's safety and effectiveness as use expands.
The post-approval position follows the standard medicines safety framework. The MHRA said suspected side effects should be discussed with a doctor, pharmacist or nurse and reported through the Yellow Card scheme, either online or through the MHRA Yellow Card app. It also directed readers to Section 4 of the Patient Information Leaflet and the Summary of Product Characteristics for the full list of reported side effects. The agency said the SmPC and Patient Information Leaflet would be published on the MHRA Products website within seven days of approval. For patients and clinicians, that documentation will be the key source for licensed use, contraindications, adverse reactions and other prescribing information as the medicine moves from regulatory approval into practice.