New Delhi, Aug. 29 -- Zydus Therapeutics, a subsidiary of Zydus Lifesciences, said on Friday that its investigational drug Saroglitazar showed positive results in a late-stage trial for patients with primary biliary cholangitis (PBC), a rare chronic liver disease.

The firm plans to file for USFDA regulatory approval in the first quarter of 2026, the company said in a release. Saroglitazar has been approved in India since 2020 for treating non-alcoholic fatty liver disease (NAFLD) and its progressive form, NASH (non-alcoholic steatohepatitis).

The EPICS-III phase 2(b)/3 clinical trial tested how safe and effective Saroglitazar is for adults who couldn't tolerate or didn't benefit from ursodeoxycholic acid (UDCA), the usual treatment.

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