Zydus Saroglitazar hits Phase 2b/3 PBC goal, FDA 2026

What Zydus announced and why it matters

Zydus Lifesciences Ltd said its US arm, Zydus Therapeutics, has reported positive topline data for saroglitazar magnesium across liver disease programs, with the most immediate regulatory focus on primary biliary cholangitis (PBC). The company said it plans to file for US Food and Drug Administration (FDA) approval in early 2026, and separately described encouraging Phase II(b) findings in metabolic dysfunction associated steatohepatitis (MASH) with fibrosis. For investors tracking India-listed pharma companies with late-stage US ambitions, the combination of a completed pivotal EPICS-III Phase 2(b)/3 trial in PBC and an endpoint hit in a biopsy-driven MASH study frames saroglitazar as a key pipeline asset.

EPICS-III trial: who was studied and what was tested

Zydus described EPICS-III as a Phase 2(b)/3 trial evaluating saroglitazar magnesium in adults with PBC who failed or could not tolerate standard-of-care treatment with ursodeoxycholic acid (UDCA). The company referred to the program as pivotal and said the trial was conducted across multiple centres.

According to the information shared, the EPICS-III trial enrolled 149 patients and evaluated a 1 mg once-daily oral dose of saroglitazar. The topline update focused on biochemical response and alkaline phosphatase (ALP), a key marker associated with disease progression in PBC.

Primary endpoint result: 48.5% treatment difference vs placebo

Zydus said EPICS-III met its primary endpoint at 52 weeks. The company reported a 48.5% higher biochemical response rate with saroglitazar (1 mg) versus placebo at week 52, with p<0.001.

The update also provided responder proportions: 56.7% of patients achieved biochemical response on saroglitazar versus 9.8% on placebo. In addition, the company said the drug produced a reduction in ALP levels by at least 15% from the starting readings, aligning with the biochemical response definition used in its communication.

Zydus also said saroglitazar reduced ALP and was associated with improvement in liver function markers including bilirubin, which is commonly monitored in PBC. It also noted that, in participants with Gilbert’s syndrome, saroglitazar impacted both total and direct bilirubin levels.

Secondary endpoint: ALP normalisation and what is still pending

Zydus said the drug met a key secondary endpoint tied to ALP normalisation. In its various disclosures, the company described a statistically significant increase in the proportion of patients achieving complete ALP level normalisation.

At the same time, Zydus said it has not yet shared the detailed secondary endpoint dataset and plans to present additional data at an upcoming scientific conference or congress. The company framed the current release as topline results rather than a full clinical readout.

Safety and tolerability: balanced adverse events

On safety, Zydus said saroglitazar was generally well tolerated in EPICS-III. The company described adverse events as balanced between the saroglitazar and placebo groups, a point it reiterated across summaries of the late-stage study.

While no numeric adverse-event rates were provided in the supplied material, the consistent message from Zydus was that the safety profile did not show an obvious imbalance versus placebo in the 52-week trial.

US FDA submission: timeline and next steps

Zydus said it intends to discuss the results with regulatory agencies and is preparing a new drug application (NDA) submission to the US FDA in Q1 2026. Separately, the company said it is building medical affairs and commercialisation capabilities ahead of a planned US launch.

The sequence matters because EPICS-III is described as a pivotal Phase 2(b)/3 trial in a rare chronic liver disease, and the company has connected the topline results directly to its planned regulatory filing timeline.

EVIDENCES-X in MASH: biopsy-driven Phase II(b) outcome

Zydus also announced positive topline results from the completed EVIDENCES-X Phase II(b) trial evaluating saroglitazar magnesium in patients with MASH and fibrosis. The study was prospective, multicentre, randomised, double-blind, and placebo controlled.

EVIDENCES-X enrolled 189 subjects who were randomised in a 1:1:1 ratio to saroglitazar 2 mg, saroglitazar 4 mg, or placebo over 52 weeks. Zydus said the study met its primary endpoint of resolution of steatohepatitis with no worsening of fibrosis at week 52, with a treatment difference of 26.5%. The company also cited encouraging findings on key secondary and exploratory endpoints, including improvements in liver histology parameters such as steatosis, inflammation, and ballooning.

What saroglitazar is already used for in India

In India, saroglitazar is approved for non-alcoholic fatty liver disease (NAFLD) and its progressive form NASH, with approvals referenced as being in place since 2020 in one of the reports provided. Zydus also noted Indian approval for indications including diabetic dyslipidemia and hypertriglyceridemia.

This matters for context because the company is pursuing additional disease areas and geographies for the same molecule, while already commercialising it in its home market.

Key trial facts at a glance

Market impact: what the update changes, and what it does not

For markets, the immediate impact is informational rather than financial because no revenue guidance, launch dates, or pricing assumptions were provided. Still, a stated plan to submit an NDA to the US FDA in Q1 2026 is a clear, time-bound catalyst for a company with an India-listed parent.

Within hepatology, PBC is typically treated first with UDCA, and the EPICS-III population highlighted by Zydus includes patients who did not respond or could not tolerate UDCA. By focusing on biochemical response and ALP normalisation at 52 weeks, the update speaks directly to endpoints physicians and regulators track in PBC. The parallel MASH readout matters as well, because EVIDENCES-X was biopsy-driven and reported a treatment difference on a histology-based primary endpoint.

Analysis: why these endpoints matter in liver drug development

Zydus positioned ALP as a key biomarker of disease progression in PBC, and its topline data emphasised both a responder definition that included ALP improvement and a secondary endpoint linked to ALP normalisation. In practical terms, that framing signals an attempt to align clinical outcomes with established monitoring tools used in PBC management.

The company also highlighted saroglitazar’s dual PPAR alpha/gamma agonist profile and said it targets bile acid toxicity and liver inflammation. Regardless of mechanism, the near-term question for investors is execution: Zydus has said it will present full results at an upcoming scientific meeting and will pursue FDA discussions ahead of an NDA in Q1 2026. Those steps will determine how quickly the topline claims are translated into a regulatory review package.

Conclusion

Zydus has reported positive topline results for saroglitazar in EPICS-III for PBC, including a 48.5% treatment difference versus placebo on biochemical response at 52 weeks, and said it plans an FDA submission in Q1 2026. The company also reported that EVIDENCES-X in MASH met its primary histology endpoint over 52 weeks. The next confirmed milestones are a fuller scientific presentation of EPICS-III data and the company’s stated plan to engage regulators before filing in early 2026.