Zydus Lifesciences confirmed Wednesday that it would seek US Food and Drug Administration approval for saroglitazar in primary biliary cholangitis, after Phase 3 trial analysis showed a stronger biochemical response than existing therapies. The Ahmedabad-based company announced the plan following its EPICS-III study readout.

Saroglitazar, a dual PPAR alpha and gamma agonist, is already marketed in India for other metabolic conditions but remains investigational in the United States. Primary biliary cholangitis is a chronic autoimmune liver disease that can progress to cirrhosis and liver failure if untreated, and affects predominantly middle-aged women.

The trial met its primary endpoint, with a significantly higher proportion of patients achieving reductions in alkaline phosphatase, a key marker of disease progression. Zydus chairman Pankaj Patel said the results positioned saroglitazar as a potential new treatment option for patients with inadequate response to standard ursodeoxycholic acid therapy.

The move places Zydus in direct competition with Ipsen's Iqirvo and Gilead's seladelpar, both recently approved second-line therapies in the same PPAR class. Analysts at Indian brokerages have flagged the US liver disease market as a key growth avenue for the company's branded pipeline.

Zydus said it intended to engage the FDA on the regulatory pathway and timeline for a new drug application, while continuing to pursue approvals in European and other international markets.