On 1 May 2026, the Medicines and Healthcare products Regulatory Agency approved linerixibat, to be marketed as Lynavoy, for the treatment of itch in adults with primary biliary cholangitis. The decision is tightly defined: it covers a specific symptom in a specific adult patient group, rather than a broad new use across liver disease. For patients living with primary biliary cholangitis, that matters because itching can be more than a minor side effect of illness. In the MHRA's framing, the approval creates a new treatment option for adults whose condition is associated with persistent itch.
The regulator explains primary biliary cholangitis, or PBC, as a condition in which bile ducts in the liver become damaged. That damage can lead to a build-up of bile acids in the blood, and the MHRA says that build-up is thought to contribute to itching. Linerixibat is intended to reduce the build-up of substances in the body, including bile acids, and in doing so reduce itch. In plain terms, the approval is based on the view that easing this underlying build-up can improve one of the condition's most burdensome symptoms.
The approved product is an orally taken film-coated tablet. The MHRA states that the recommended dose is one tablet twice a day. That gives clinicians and patients a straightforward dosing format, but the practical detail will sit in the formal product documents rather than the announcement alone. The MHRA said the Summary of Product Characteristics and the Patient Information Leaflet would be published on its products website within seven days of approval.
The evidence cited by the regulator comes from GLISTEN, a global Phase 3 clinical trial. In that study, 238 patients were randomly assigned to receive either linerixibat 40 mg twice daily or a placebo over 24 weeks. According to the MHRA, the results showed that linerixibat significantly reduced itching and improved sleep disruption caused by itching. The agency said the trial's main measure, the Monthly Itch Score, showed a statistically significant improvement for patients treated with linerixibat when compared with placebo.
The approval was granted to GlaxoSmithKline UK Limited and was submitted and approved through the National Procedure. For readers outside medicines regulation, that means the application was handled through the UK route identified by the MHRA for this product. For clinicians, the next reference points are the SmPC and the patient leaflet once published. Those documents set out the approved indication, dosing instructions, warnings and side-effect information, with the MHRA noting that the full list of reported side effects appears in Section 4 of the product information.
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, said the approval provides a new treatment option for adults with primary biliary cholangitis who experience itching linked to their condition. He also said the agency will continue to monitor the safety and effectiveness of linerixibat as it is used more widely. That reflects the MHRA's wider role as the UK medicines regulator and an executive agency of the Department of Health and Social Care. In the regulator's own terms, medicines are authorised on the basis that benefits justify risks, and that judgement continues after approval through routine monitoring in real-world use.
The public safety message in the announcement is consistent with standard MHRA practice. Anyone who thinks they may be experiencing a side effect is advised to speak to a doctor, pharmacist or nurse and to report the concern through the Yellow Card scheme, including by app. For patients, the immediate effect of the decision is that a new regulated treatment has entered the UK system for PBC-related itch. For clinicians, the approval adds an authorised option supported by Phase 3 evidence and accompanied by the usual post-market reporting requirements that sit behind UK medicines oversight.