Pharmaceutical company GSK plc has entered into a licensing agreement with Italian drugmaker Alfasigma S.p.A. granting the latter worldwide exclusive rights to develop, manufacture and commercialize the investigational drug linerixibat. The therapy is being developed as a potential treatment for cholestatic pruritus associated with Primary Biliary Cholangitis (PBC), a chronic liver condition that can cause severe itching and progressive liver damage.
Under the terms of the agreement, Alfasigma will take responsibility for the global development and commercialization of Linerixibat, an oral therapy designed to inhibit the ileal bile acid transporter (IBAT). This mechanism aims to reduce the accumulation of bile acids believed to contribute to cholestatic pruritus, a debilitating symptom that significantly affects quality of life for patients with PBC.
Primary biliary cholangitis is a rare autoimmune disease in which the body’s immune system gradually damages bile ducts in the liver. As the disease progresses, bile flow becomes impaired, leading to liver inflammation, scarring and, in severe cases, liver failure. Many patients experience chronic itching that can disrupt sleep and daily activities, and treatment options remain limited.
Linerixibat has received Orphan Drug Designation in the United States, the European Union and Japan, reflecting the rarity of the condition and the need for additional therapies. Regulatory authorities in United States, European Medicines Agency jurisdictions, the United Kingdom, China and Canada are currently reviewing marketing applications for the therapy. The drug has also received priority review status in China.
The regulatory submissions are supported by results from the GLISTEN trial, a phase III clinical trial evaluating the therapy in patients with cholestatic pruritus due to PBC. According to trial results, the study met its primary and key secondary endpoints, demonstrating rapid and sustained reductions in itching severity compared with placebo. Participants receiving linerixibat also reported improvements in sleep disruption linked to pruritus. The drug’s safety profile was generally consistent with previous studies and aligned with its mechanism of action as an IBAT inhibitor.
Despite the promising clinical data, linerixibat has not yet been approved in any country.
Tony Wood said the agreement allows GSK to focus on its broader pipeline in liver diseases while ensuring the continued development of linerixibat. He noted that conditions such as chronic hepatitis B, metabolic dysfunction-associated steatohepatitis and alcohol-related liver disease collectively contribute to millions of deaths worldwide each year and remain key priorities for the company’s research efforts.
Alfasigma’s leadership believes the deal aligns with its strategy to expand in specialty and rare diseases. Francesco Balestrieri said the company’s experience in hepatology and its global presence in more than 100 markets position it well to advance linerixibat’s development and potential commercialization.
If approved, linerixibat could offer a new therapeutic option for patients with primary biliary cholangitis who struggle with severe itching and limited treatment choices. The companies say the collaboration aims to accelerate progress toward bringing the therapy to patients worldwide.