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On March 17, 2026, the US FDA approved Lynavoy (linerixibat) for cholestatic pruritus associated with primary biliary cholangitis.
The approval came days after GSK and Alfasigma announced a March 9 licensing agreement under which Alfasigma acquired exclusive worldwide rights to develop, manufacture, and commercialize linerixibat. Under the agreement, GSK receives a $300 million upfront payment and a $100 million milestone tied to US approval.
Linerixibat is an ileal bile acid transporter inhibitor, and company materials say US data indicate that itch is frequently undocumented in medical records and that up to one-third of patients with clinically significant itch do not receive treatment.
In the Phase 3 GLISTEN trial, linerixibat significantly improved pruritus and itch-related sleep interference over 24 weeks versus placebo; at Week 24, the adjusted mean difference in WI-NRS change was -0.72 versus placebo, and diarrhea was the most common adverse event.
Sources: GSK and Alfasigma announce agreement on worldwide rights for linerixibat, FDA Novel Drug Approvals for 2026, PubMed
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