Zydus Lifesciences eyes US filing for chronic liver disease drug saroglitazar after successful PBC trial
Published on 29/08/2025 07:50 PM
Zydus Lifesciences eyes US filing for chronic liver disease drug saroglitazar after successful PBC trialSaroglitazar was generally well tolerated, with adverse events balanced between the saroglitazar-treated and placebo-treated groups. Based on these results, Zydus Therapeutics intends to submit a US regulatory application for saroglitazar in the first quarter of 2026. Shares of Zydus Lifesciences Ltd ended at ₹980.75, up by ₹3.85 or 0.39%, on the BSE today (August 29).By Jomy Jos Pullokaran August 29, 2025, 7:50:56 PM IST (Published)2 Min ReadDrug maker Zydus Lifesciences Ltd on Friday (August 29) announced that its US-based innovation-focused specialty arm, Zydus Therapeutics, reported positive topline results from the pivotal EPICS-III phase 2(b)/3 clinical trial.
The trial evaluated the safety and efficacy of saroglitazar, an investigational alpha/gamma peroxisome proliferator-activated receptor (PPAR) agonist, for the treatment of adult patients with primary biliary cholangitis (PBC) who had an inadequate response or intolerance to ursodeoxycholic acid (UDCA), the current standard of care.
The trial met its primary composite endpoint, with a statistically significant treatment difference of 48.5% in achieving a clinically meaningful biochemical response, favouring saroglitazar 1mg over placebo (P