Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Limited, a global innovation-led health care company, today announced that the US Food and Drug Administration (US FDA) granted Priority Review to the New Drug Application (NDA) for saroglitazar. The proposed indication is for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The US FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. Priority Review directs US FDA attention and resources to applications for drugs that, if approved, may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.
“The acceptance of our NDA with Priority Review highlights the significant unmet need that exists for patients with PBC and represents an important step in the path to making saroglitazar available in the US,” said Managing Director of Zydus Lifesciences, Dr. Sharvil Patel. “We look forward to collaborating with the US FDA during the NDA Priority Review process and will, in parallel, continue to build our medical affairs and commercialization capabilities towards a potential US launch in the fourth quarter of FY 27.”
The NDA is supported by the EPICS-III trial Phase 3 results, a randomized, double-blind, placebo-controlled study evaluating saroglitazar in adult patients with PBC who had an inadequate response to or intolerance of UDCA. The EPICS-III trial Phase 3 results will be presented as a late-breaking session at the European Association for the Study of the Liver (EASL) Congress in Barcelona, Spain on Saturday, May 30, 2026.
“EPICS-III is a registrational study that tested saroglitazar as a second-line treatment in patients with PBC. The study met its primary endpoint, demonstrating a clinically meaningful biochemical response, along with a favorable safety and tolerability profile,” said Raj Vuppalanchi, MD, Professor of Medicine at Indiana University School of Medicine and Global Principal Investigator for the EPICS-III study.
In the trial (N = 148), saroglitazar met its primary endpoint at Week 52, demonstrating a statistically significant improvement in biochemical response compared to placebo. A total of 56.7% of patients treated with saroglitazar achieved biochemical response compared with 9.8% of patients receiving placebo, a treatment difference of 48% (95% CI: 35.3, 60.8) (p < 0.001). Among participants with baseline ALP ≤ 3 x ULN, biochemical response was 83.1% and 14.7%, respectively. Composite biochemical response was defined as achieving the following at 12 months: ALP < 1.67 x ULN, ≥ 15% decrease in ALP from baseline, and total bilirubin ≤ ULN or direct bilirubin ≤ ULN in subjects with known Gilbert’s syndrome.
Patients randomized to receive saroglitazar had a mean baseline ALP level of 363 U/L, compared with 317.2 U/L in the placebo arm. At Week 52, saroglitazar demonstrated a treatment difference of -124.1 U/L (-40.1%) in least-squares mean change from baseline in ALP, with patients receiving saroglitazar achieving a -115.4 U/L (-33.5%) reduction from baseline compared with a +8.8 U/L (+6.5%) increase from baseline among patients receiving placebo.
“The magnitude of separation between saroglitazar and placebo in biochemical response is a clinically meaningful result for patients whose disease continues to progress on UDCA,” said Dr. Kris Kowdley, Director, Liver Institute Northwest; Professor, Elson S. Floyd. College of Medicine, Washington State University; Senior Scientific Advisor and Medical Director, Velocity Clinical Research. “Achieving meaningful reductions in ALP is an important treatment goal in PBC as it is a surrogate marker predictive of long-term outcomes. These results suggest saroglitazar may provide a promising therapeutic option for patients with a suboptimal response to UDCA alone, when ALP continues to rise above target.”
As a secondary endpoint, at Week 24, patients treated with saroglitazar also experienced a statistically significant reduction in pruritus compared to placebo, with a change from baseline in 5-D Itch Total score of -5.9 versus -2.7, a treatment difference of -3.2 (95% CI: -5.66, -0.82) (p = 0.009). At Week 52, saroglitazar-treated patients experienced a reduction of -4.6 compared with -4.4 on placebo, which was not statistically significant.
Saroglitazar was generally well-tolerated in the EPICS-III trial. Most treatment-emergent adverse events (TEAEs) were mild to moderate in nature. Serious adverse events were reported in 6.3% of patients in the saroglitazar group versus 11.1% in the placebo group. None were considered related to study treatment by the investigators, and there were no treatment-related deaths. TEAEs occurring in >5% of patients and at least 2% more frequently on saroglitazar versus placebo were headache, hypertension, upper respiratory tract infection, abdominal pain, COVID-19, diarrhea, and vitamin D deficiency.