Zydus Therapeutics update on clinical trial of Saroglitazar

Used for treatment of Primary Biliary Cholangitis

Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences, today announced positive topline results from the pivotal EPICS-III Phase 2(b)/3 clinical trial. In this trial, the safety and efficacy of Saroglitazar, an investigational alpha/gamma Peroxisome Proliferator-Activated Receptor (PPAR) agonist, was evaluated 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.

• Trial met the primary endpoint, with a statistically significant treatment difference in the percentage of patients achieving a clinically meaningful biochemical response with Saroglitazar compared to placebo.
• Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients. ?h
• Zydus Therapeutics, the US-based innovation-focused specialty arm of Zydus Lifesciences, intends to submit a U.S. regulatory application for Saroglitazar in the first quarter of 2026.

 

 

Powered by Capital Market - Live News