The Medicines and Healthcare products Regulatory Agency approves linerixibat (Lynavoy) for PBC-related itch in adults, based on Phase 3 GLISTEN data showing significant symptom improvement.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved linerixibat (Lynavoy) for the treatment of pruritus (itching) in adults with primary biliary cholangitis (PBC). The approval was granted on 1 May 2026 to GlaxoSmithKline (GSK), the marketing authorisation holder, which has licensed linerixibat to Alfasigma under an agreement granting worldwide exclusive rights for its development, manufacture and commercialisation.
The decision follows earlier regulatory progress in other regions, including approval by the U.S. Food and Drug Administration (FDA), where Lynavoy became the first therapy specifically indicated for PBC-related itch.
Linerixibat is administered as an oral, film-coated tablet, with a recommended dose of one tablet taken twice daily.
The approval is supported by data from the global Phase 3 GLISTEN trial (NCT04950127), which evaluated the efficacy and safety of linerixibat in patients with PBC-associated pruritus. The study enrolled 238 patients, who were randomized to receive either linerixibat 40 mg twice daily or placebo over a 24-week period.
Results showed that linerixibat significantly reduced itch severity and improved sleep disruption compared with placebo. The primary endpoint, measured using the Monthly Itch Score, demonstrated a statistically significant improvement in patients receiving linerixibat.
According to Julian Beach, interim executive director of healthcare quality and access at the MHRA, the approval provides an additional treatment option for adults with PBC experiencing itching. He added that the agency will continue to monitor the medicine’s safety and effectiveness as its use expands in clinical practice.
The therapy is also under regulatory review in Asia, with China’s National Medical Products Administration (NMPA) granting priority review status for the same indication, reflecting continued global regulatory momentum.
Primary biliary cholangitis is a chronic liver condition in which the bile ducts become progressively damaged. This leads to accumulation of bile acids in the bloodstream, which is considered a key driver of persistent itching. Linerixibat reduces the build-up of bile acids and related substances, helping to alleviate this symptom.
Reference
MHRA approves Linerixibat (Lynavoy) for the treatment of itch due to biliary tract disease – GOV.UK
About the Writer
Nikita Jha, BPharm a pharmacy graduate specializing in medical writing, with a strong ability to interpret complex medical and regulatory information and translate it into clear, accurate, and evidence-based healthcare content. Known for her attention to detail and precision, she focuses on delivering high-quality scientific communication that supports drug safety and informed decision-making.