Gilead Initiates Phase IV Clinical Trial of Seladelpar in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that a randomized, double-blind, placebo-controlled study evaluating the impact of Seladelpar on clinical outcomes in patients with primary biliary cholangitis (PBC) and compensated cirrhosis, conducted by Gilead Sciences, Inc./Gilead Sciences, Inc. (Shanghai)/Lonza Tampa LLC, has been initiated. The clinical trial registration number is CTR20253298, with the initial information disclosure date on August 15, 2025.

The drug formulation is capsules. Subjects with CP-A cirrhosis will start dosing at 10 mg once daily; subjects with CP-B cirrhosis will start dosing at 5 mg once daily, administered orally at approximately the same time each day for a maximum duration of 156 weeks. The purpose of this trial is to evaluate the effect of Seladelpar compared to placebo on EFS.

Seladelpar is a chemical drug indicated for primary biliary cholangitis (PBC) with compensated cirrhosis. Primary biliary cholangitis is an autoimmune liver disease that primarily damages intrahepatic bile ducts, potentially leading to cholestasis and cirrhosis. Symptoms include fatigue, pruritus, etc. Diagnosis relies on blood tests, autoantibody detection, and liver biopsy.

The primary endpoint of this trial includes event-free survival at 36 months; secondary endpoints include overall survival at 36 months, survival without liver transplantation, time to hospitalization due to any adjudicated event meeting the criteria, and time to each subsequent adjudicated PBC clinical event.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 40 participants in China and 318 participants internationally. Internationally, 78 participants have been enrolled.

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Editor: Xiaolang Express