Zydus Lifesciences to Seek US Approval for Saroglitazar Following Successful PBC Trial

30 Aug 2025 , 11:24 AM

Zydus Lifesciences Ltd said on Friday that its US-based arm, Zydus Therapeutics, has reported encouraging late-stage results from a trial of saroglitazar, an experimental treatment for a chronic liver condition.

The study, known as EPICS-III, tested the drug in adults with primary biliary cholangitis (PBC) a rare, progressive liver disease that often leaves patients with limited treatment options. Participants in the trial had either failed to respond to or could not tolerate ursodeoxycholic acid (UDCA), the existing standard therapy.

Results showed that saroglitazar met its main study goal, with nearly half of patients showing a meaningful improvement in liver enzyme and bilirubin levels compared with those on placebo. Both markers are widely used to track the progression of PBC.

The medicine also cleared a key secondary test, with more patients achieving normalised enzyme levels after 52 weeks of treatment. Importantly, the company said the drug was well tolerated, with side effects similar in both the treatment and placebo groups. Buoyed by the findings, Zydus said it plans to file for US regulatory approval in early 2026.

“This outcome strengthens our commitment to bring forward new therapies for chronic liver diseases, where unmet needs remain high,” said Pankaj Patel, Chairman of Zydus Lifesciences. “Saroglitazar is the first dual PPAR agonist to show positive phase 3 data in PBC and could give doctors and patients a much-needed new option.”

For feedback and suggestions, write to us at [e-mail]