Zydus Subsidiary Reports Positive Trial Results for Liver Drug Saroglitazar

Zydus Therapeutics, the US-based wholly owned subsidiary of Zydus Lifesciences Ltd., has reported positive topline results from late-stage clinical trials evaluating its investigational drug Saroglitazar. The company disclosed the update in a stock exchange filing Friday.

The EPICS-III Phase 2(b)/3 trial assessed the safety and efficacy of Saroglitazar in adult patients with primary biliary cholangitis, a rare chronic liver disease that primarily affects women and can progress to bile duct damage, fibrosis, cirrhosis, and potentially liver failure.

According to Zydus, the trial met its primary endpoint and the drug was generally well tolerated. The company now plans to submit the findings to the US Food and Drug Administration in the first quarter of 2026.

Zydus began developing Saroglitazar in 2013, expanding into liver disease studies from 2015. If Phase 3 outcomes are successful, the company expects Indian patients to gain access by 2026–27, while US and European approvals may take until 2027–28.