PENNINGTON, New Jersey and AHMEDABAD, India, May 28, 2026
Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences, has achieved a major regulatory milestone after the U.S. Food and Drug Administration (FDA) granted Priority Review to its New Drug Application (NDA) for saroglitazar for the treatment of Primary Biliary Cholangitis (PBC). The FDA has assigned a PDUFA target action date of November 27, 2026, accelerating the review of a therapy that could address a significant unmet medical need among patients who do not respond adequately to current standard treatments. Supported by positive Phase 3 EPICS-III clinical trial results, saroglitazar demonstrated compelling efficacy and a favorable safety profile, positioning the investigational therapy as a potential new treatment option for patients living with this rare and progressive autoimmune liver disease.
Phase 3 EPICS-III Trial Delivers Strong Clinical Results
The NDA submission is supported by data from the pivotal EPICS-III Phase 3 trial, a randomized, double-blind, placebo-controlled study evaluating saroglitazar in adults with PBC who experienced an inadequate response to ursodeoxycholic acid (UDCA) or were unable to tolerate the therapy. PBC is a chronic autoimmune disease that gradually damages the bile ducts, leading to liver inflammation, fibrosis, cirrhosis, liver failure, and potentially the need for transplantation.
In the registrational study involving 148 patients, saroglitazar successfully achieved its primary endpoint at Week 52, demonstrating a statistically significant improvement in biochemical response compared with placebo. A total of 56.7% of patients receiving saroglitazar achieved biochemical response, compared with only 9.8% of patients in the placebo group, representing a treatment difference of 48% and a highly significant p-value of less than 0.001.
The therapy also demonstrated a substantial impact on alkaline phosphatase (ALP), a key biomarker used to assess disease activity and long-term prognosis in PBC. Patients treated with saroglitazar experienced a 33.5% reduction in ALP levels, compared with a 6.5% increase among placebo-treated patients, resulting in a treatment difference of more than 40%. These findings highlight the drug’s potential to significantly improve disease control and reduce progression risk in patients with limited therapeutic options.
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Novel PPAR α/γ Agonist Targets Multiple Disease Pathways
Saroglitazar is a first-in-class Peroxisome Proliferator-Activated Receptor (PPAR) α/γ agonist designed to address multiple biological mechanisms involved in PBC. The therapy works by targeting both bile acid toxicity and liver inflammation, two critical drivers of disease progression. This dual-action approach differentiates saroglitazar from currently available therapies and may offer enhanced disease control for patients whose condition continues to worsen despite standard treatment.
Beyond improvements in biochemical markers, the EPICS-III trial also demonstrated statistically significant reductions in pruritus (itching) at Week 24, one of the most debilitating symptoms experienced by patients with PBC. Although differences at Week 52 were not statistically significant, the early symptom improvement provides additional evidence supporting the therapy’s clinical benefit.
Importantly, saroglitazar exhibited a favorable safety and tolerability profile. Most adverse events were mild to moderate, and serious adverse events occurred less frequently among saroglitazar-treated patients than in the placebo group. No treatment-related deaths were reported during the study, reinforcing confidence in the therapy’s benefit-risk profile.
Priority Review Accelerates Path Toward Potential U.S. Approval
The FDA’s Priority Review designation reflects the agency’s assessment that saroglitazar may offer significant improvements in the treatment of a serious disease. The investigational therapy has already received Orphan Drug Designation and Fast Track Designation, highlighting its potential importance within the rare liver disease community.
The Phase 3 EPICS-III results are scheduled to be presented as a late-breaking presentation at the European Association for the Study of the Liver (EASL) Congress 2026, further increasing visibility for the program among global hepatology experts. Zydus has also announced plans to launch saroglitazar in the United States by March 2027, should regulatory approval be granted.
With compelling Phase 3 efficacy data, favorable safety findings, and expedited FDA review status, saroglitazar is emerging as a promising new therapeutic option for patients with Primary Biliary Cholangitis who continue to face disease progression despite existing treatments. The Priority Review milestone strengthens Zydus Therapeutics’ growing presence in specialty liver diseases and underscores the company’s commitment to developing innovative therapies for serious and underserved medical conditions worldwide.
Source: Zydus press release
