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Linerixibat is an oral, minimally absorbed small-molecule ileal bile acid transporter inhibitor developed by GSK and later licensed globally to Alfasigma. It is designed to block reuptake of bile acids in the terminal ileum, thereby reducing the circulating bile-acid pool and addressing cholestatic pruritus, particularly in primary biliary cholangitis. The program has included extensive Phase 1 pharmacology and drug-drug interaction studies, Phase 2 studies such as GLIMMER, a Phase 3 program including GLISTEN, long-term safety follow-up, and compassionate-use access in adults with primary biliary cholangitis and cholestatic pruritus. Based on the provided context, linerixibat became the first medicine approved in the United States specifically for this indication shortly after the March 2026 Alfasigma licensing deal.
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