Nashville, Tennessee, U.S., October 12, 2026
Zydus Therapeutics has presented a new post-hoc analysis of the Phase III EPICS-III clinical trial, reporting a greater biochemical response with investigational saroglitazar than with placebo across geographic subgroups of patients with primary biliary cholangitis (PBC). The findings were presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting, adding to the clinical evidence being developed for this investigational treatment in a chronic autoimmune liver disease. PBC damages the small bile ducts within the liver, potentially leading to impaired bile flow, persistent inflammation and progressive liver injury. Although currently available treatments can help manage the condition, some patients continue to experience abnormal liver biochemical markers and may need additional therapeutic options. The EPICS-III analysis examined whether the biochemical response observed with saroglitazar was consistent across different geographic populations. The reported results favored saroglitazar over placebo across the analyzed subgroups, supporting further investigation of its potential role in PBC. However, because this was a post-hoc analysis, the findings should be interpreted as additional exploratory evidence rather than independent confirmation of clinical benefit.
Geographic Subgroup Results Show Biochemical Responses
The exploratory analysis compared patients treated with saroglitazar against those receiving placebo in the U.S. and non-U.S. populations. In the U.S. subgroup, 60.7% of patients receiving saroglitazar achieved a composite biochemical response, compared with 0% receiving placebo. In the non-U.S. subgroup, the corresponding response rates were 55.1% and 13.5%, respectively. The treatment difference was numerically higher in the U.S. population at 60.7 percentage points, compared with 41.6 percentage points in the non-U.S. group. The analysis included 28 saroglitazar-treated and 14 placebo-treated patients in the U.S. subgroup, alongside 69 saroglitazar-treated and 37 placebo-treated patients in the non-U.S. subgroup, which comprised Argentina, Iceland and Turkey. These findings suggest that biochemical responses were observed across the geographic groups evaluated. However, the subgroup sizes were relatively small, and the analysis was not designed to establish that treatment effects differ by geography. The results should therefore be viewed as exploratory and interpreted alongside the main EPICS-III trial findings.
Saroglitazar Targets Unmet Needs in PBC Treatment
Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease in which the immune system damages the small bile ducts inside the liver. This can disrupt bile flow, cause bile acids to accumulate and contribute to progressive liver injury. Patients may experience fatigue, itching, abnormal liver enzyme levels and, in advanced cases, cirrhosis. Ursodeoxycholic acid (UDCA) is commonly used as first-line treatment, but some patients do not respond adequately or cannot tolerate it, creating a need for additional treatment options. Saroglitazar is an investigational dual PPAR-α/γ agonist being studied for its potential to improve biochemical markers associated with PBC. The EPICS-III trial evaluated the treatment in adults who had an inadequate response to or intolerance of UDCA. In the geographic subgroup analysis, differences in alkaline phosphatase (ALP) normalization were not substantially different between the U.S. and non-U.S. populations. At Week 52, the treatment differences in ALP normalization were 7.7 and 9.6 percentage points, respectively. Saroglitazar remains investigational in the United States, and its safety and effectiveness for PBC have not been established by FDA approval.
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Regulatory Review and Future Development
Zydus Therapeutics is a wholly owned subsidiary of Zydus Lifesciences Limited, which is advancing saroglitazar as a potential treatment option for patients with PBC. The company has reported that the U.S. Food and Drug Administration granted the drug Priority Review for its new drug application, with a target action date of November 27, 2026. The principal EPICS-III trial results previously reported a significant improvement in the composite biochemical response compared with placebo, while the latest geographic analysis adds information about responses across patient subgroups. The FDA’s ongoing review will consider the totality of available evidence, including efficacy and safety data. The exploratory analysis does not independently determine whether the medicine will receive approval. The next major milestone is the FDA’s regulatory decision, which will determine whether saroglitazar can become an additional treatment option for eligible patients in the United States.
Source: Zydus Therapeutics press release
