Zydus Therapeutics’ Saroglitazar Hits Phase 3 Milestone in PBC Trial

Zydus Therapeutics’ Saroglitazar Hits Phase 3 Milestone in PBC Trial

By, Admin 1 September 2025

Zydus Therapeutics, the US arm of Zydus Lifesciences Ltd., has reported positive topline results from its pivotal EPICS-III phase 2b/3 trial of saroglitazar in patients with primary biliary cholangitis (PBC) who failed or could not tolerate standard treatment with ursodeoxycholic acid (UDCA).

Key Outcomes

  • Primary endpoint met: 48.5% higher biochemical response rate with saroglitazar (1 mg) vs. placebo at 52 weeks (p<0.001).
  • Secondary endpoint achieved: Significant normalization of alkaline phosphatase (ALP) levels.
  • Tolerability: Safety profile balanced between saroglitazar and placebo groups.
  • Next step: Regulatory submission planned for the US FDA in Q1 2026.

Why It Matters

PBC is a rare, progressive autoimmune liver disease that destroys bile ducts, causing bile buildup, fibrosis, cirrhosis, and potentially liver failure or the need for transplantation. Current therapy with UDCA is not effective for all patients. Elevated ALP and bilirubin levels are strong predictors of disease progression.

Saroglitazar’s dual PPAR alpha/gamma agonist profile targets both bile acid toxicity and liver inflammation, making it the first in its class to show positive phase 3 results in PBC.

Leadership Commentary

  • Pankaj Patel, Chairman of Zydus Lifesciences:

“Saroglitazar is the first PPAR alpha/gamma agonist to demonstrate positive phase 3 data in PBC. These results strengthen our mission to advance treatments for chronic liver diseases where options remain limited.”

  • Dr. Raj Vuppalanchi, Indiana University & Global PI:

“Patients with PBC often continue to struggle despite standard therapy. New options like saroglitazar could change how we personalize care.”

The Bigger Picture

  • Regulatory momentum: Saroglitazar holds Orphan Drug and Fast Track Designations from the US FDA.
  • Company profile: Zydus Therapeutics is focused on rare and serious liver diseases including PBC and NASH. Its parent company, Zydus Lifesciences, employs 28,000 people worldwide, with over 1,500 scientists in R&D.

The full EPICS-III dataset will be presented at an upcoming scientific congress.

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