The Medicines and Healthcare products Regulatory Agency (MHRA) has\u202ftoday\u202f1 May\u202f2026,\u202fapproved\u202fLinerixibat\u00a0(Lynavoy) for use to treat an itch in adults with\u00a0primary biliary cholangitis (PBC).\u00a0<\/p>\n
PBC is a condition where bile ducts in the liver become damaged, leading to a\u00a0build-up\u00a0of bile acids in the blood. This build-up is thought to cause itching.\u00a0Linerixibat\u00a0helps to reduce the build-up of substances, including bile acids, in the body\u00a0and so reduce itching.\u00a0<\/p>\n
Linerixibat\u00a0is\u202fadministered\u00a0via\u00a0an orally ingested\u00a0film-coated tablet. The recommended dose is one tablet taken twice a day.\u00a0<\/p>\n
A global Phase 3 clinical trial,\u00a0Glisten,\u00a0evaluated the safety and effectiveness of\u00a0linerixibat\u00a0for treating itching in patients with PBC. In the study, 238 patients were randomly assigned to receive either\u00a0linerixibat\u00a040 mg twice daily or a placebo for 24 weeks.\u00a0<\/p>\n
The results showed that\u00a0linerixibat\u00a0significantly reduced itching and improved sleep disruption caused by itching. The study\u2019s main measure, the Monthly Itch Score, showed a statistically significant improvement in patients treated with\u00a0linerixibat\u00a0compared with those given placebo.\u00a0<\/p>\n
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, said:\u00a0<\/p>\n
\u201cThe approval of\u00a0linerixibat\u00a0provides a new treatment option for adults with primary biliary cholangitis\u00a0who experience itching associated with their condition.\u00a0<\/p>\n
\u201cAs with all medicines, we will continue to closely monitor the safety and effectiveness of\u00a0linerixibat\u00a0as it is used more widely.\u201d\u00a0<\/p>\n
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.\u00a0<\/p>\n