Zydus Therapeutics Receives Priority Review Status for Saroglitazar in Primary Biliary Cholangitis Treatment

Zydus Therapeutics, the wholly owned pharmaceutical subsidiary of Zydus Lifesciences Limited, has secured Priority Review designation from the US Food and Drug Administration for its New Drug Application targeting saroglitazar as a treatment for primary biliary cholangitis (PBC).

The drug is being evaluated for use alongside ursodeoxycholic acid (UDCA) in adults showing insufficient response to UDCA alone, or as a standalone therapy for patients unable to tolerate UDCA. The FDA has set a Prescription Drug User Fee Act target action date of November 27, 2026.

Priority Review status indicates the FDA believes the medication could represent a meaningful advance in treating, diagnosing, or preventing serious conditions and warrants accelerated consideration.

Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, said the Priority Review recognition reflects substantial therapeutic gaps in PBC management. "This represents a critical milestone toward bringing saroglitazar to American patients," he stated, adding that the company plans to prepare for a potential US market launch in the fourth quarter of fiscal year 2027 while working with regulators during the review process.

The application rests on findings from the EPICS-III Phase 3 trial, a randomized, double-blind, placebo-controlled investigation of saroglitazar in adult PBC patients with inadequate UDCA response or intolerance. Results from this registrational study are being presented as a late-breaking session at the European Association for the Study of the Liver Congress in Barcelona on May 30, 2026.

The trial enrolled 148 participants and achieved its primary objective at the 52-week mark. Among those receiving saroglitazar, 56.7 percent demonstrated biochemical response compared with 9.8 percent in the placebo group—a 48 percentage point difference (95% CI: 35.3, 60.8; p < 0.001). For patients with baseline alkaline phosphatase (ALP) levels at or below three times the upper limit of normal, the response rate reached 83.1 percent versus 14.7 percent with placebo.

Biochemical response was defined as simultaneously achieving alkaline phosphatase below 1.67 times the upper limit of normal, at least a 15 percent decrease in ALP from baseline, and total bilirubin within normal limits—or direct bilirubin within normal limits for those with Gilbert's syndrome—at 12 months.

Mean baseline ALP measured 363 U/L in the saroglitazar group and 317.2 U/L among placebo recipients. By week 52, saroglitazar produced a least-squares mean reduction of 115.4 U/L (33.5 percent) from baseline, while placebo showed an increase of 8.8 U/L (6.5 percent), yielding a treatment difference of -124.1 U/L (-40.1 percent).

Dr. Raj Vuppalanchi, Professor of Medicine at Indiana University School of Medicine and Global Principal Investigator for EPICS-III, noted that the trial tested saroglitazar as a second-line option in PBC patients. "The study met its primary endpoint, showing clinically meaningful biochemical improvement with a favorable safety and tolerability profile," he explained.

Dr. Kris Kowdley, Director of the Liver Institute Northwest and Professor at Washington State University's Elson S. Floyd College of Medicine, highlighted the clinical significance of the separation between treatment groups. "The magnitude of difference between saroglitazar and placebo represents a meaningful result for patients whose disease continues advancing despite UDCA therapy," he observed. "Achieving substantial ALP reductions matters considerably in PBC, as ALP serves as a predictive marker for long-term outcomes. These findings suggest saroglitazar could offer a valuable therapeutic pathway for patients with suboptimal response to UDCA monotherapy."

As a secondary endpoint, patients on saroglitazar experienced statistically significant pruritus reduction at week 24, with a 5-D Itch Total score change of -5.9 compared to -2.7 for placebo (treatment difference: -3.2; 95% CI: -5.66, -0.82; p = 0.009). At week 52, the difference narrowed, with saroglitazar showing a -4.6 change versus -4.4 for placebo, which did not reach statistical significance.

Saroglitazar demonstrated acceptable tolerability throughout the trial. Most treatment-emergent adverse events were mild or moderate. Serious adverse events occurred in 6.3 percent of saroglitazar recipients versus 11.1 percent receiving placebo, with investigators determining none were related to the study medication and no treatment-associated deaths occurring.

Adverse events appearing in more than 5 percent of patients and at least 2 percentage points more frequently with saroglitazar than placebo included headache, hypertension, upper respiratory tract infection, abdominal pain, COVID-19, diarrhea, and vitamin D deficiency.