Post Hoc Analysis of Phase 3 EPICS-III Trial Shows Greater Biochemical Response With Saroglitazar vs Placebo in PBC

Zydus Therapeutics' post hoc analysis of the Phase 3 EPICS-III trial at ACG 2026 showed greater biochemical response with investigational saroglitazar than placebo in PBC: U.S. 60.7% vs 0%, non-U.S.

Mon 12 Oct 2026

Composite biochemical response (U.S.)

60.7% vs 0%

Composite biochemical response (non-U.S.)

55.1% vs 13.5%

ALP normalization treatment difference at Week 52

7.7% vs 9.6%

What happened

Zydus Therapeutics Inc., a wholly owned subsidiary of Zydus Lifesciences Ltd, shared new analyses from the pivotal EPICS-III Phase 2(b)/3 clinical trial of saroglitazar in adult patients with primary biliary cholangitis (PBC). The post hoc exploratory analysis of geographic subgroups was shared in a late-breaking oral presentation at the American College of Gastroenterology (ACG) 2026 Annual Meeting.

The product

Saroglitazar is an investigational product that has not been approved by the U.S. Food and Drug Administration; its safety and effectiveness have not been established. It is a novel Peroxisome Proliferator-Activated Receptor (PPAR) alpha/gamma agonist under investigation for the treatment of PBC, and has received Orphan Drug Designation, Fast Track Designation and Priority Review from the U.S. FDA for the treatment of PBC.

What the post hoc analysis compared

It investigated whether treatment effects observed with saroglitazar are consistent across regions, with particular focus on U.S. versus non-U.S. patients. The composite non-U.S. population consisted of Argentina, Iceland and Turkey. The presenter noted that this was a post hoc analysis and the findings should be interpreted accordingly.

The results

• Composite biochemical response rates were greater with saroglitazar than placebo in both regions: U.S. 60.7% vs 0%, and non-U.S. 55.1% vs 13.5%.
• A larger unstratified treatment difference was observed in the U.S. subgroup (Δ 60.7%) than in the non-U.S. subgroup (Δ 41.6%).
• ALP normalization treatment difference rates at Week 52 were not substantially different between the U.S. and non-U.S. subgroups (7.7% vs 9.6%).

Tolerability

In EPICS-III, saroglitazar was generally well tolerated, with adverse events generally balanced between saroglitazar-treated and placebo-treated patients. The most common adverse reactions experienced by saroglitazar-treated patients enrolled in the trial were pruritus, headache and urinary tract infection.

What lies ahead

Saroglitazar is currently under review by the U.S. FDA. If approved, Zydus Therapeutics plans to launch saroglitazar in the United States by March 2027. Zydus Therapeutics is developing saroglitazar for the treatment of PBC in combination with UDCA in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

In short

This is an update on clinical data for an investigational product that is still awaiting a U.S. regulatory decision, rather than a commercial or financial announcement.

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