Zydus Therapeutics will file for the US Food and Drug Administration (FDA) approval of its late-stage primary biliary cholangitis (PBC) drug, saroglitazar magnesium.
This follows the positive results of the Phase IIb/III EPICS-III (NCT05133336) clinical trial, where the peroxisome proliferator-activated receptor (PPAR) agonist met its primary and secondary endpoints. This was observed in patients unresponsive to standard of care (SoC) treatment of ursodeoxycholic acid (UDCA).
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During the study, saroglitazar was found to enhance biochemical responses by 48.5% in adult patients compared with placebo, characterised by a ≥15% decrease in the upper limit of normal (ULN) alkaline phosphatase (ALP) – a key marker of disease progression in PBC.
When given orally once daily, saroglitazar also impacted both total and direct bilirubin levels in participants with Gilbert’s syndrome, which sees patients develop mild jaundice due to a build-up of the red blood cell breakdown byproduct.
The drug also met its secondary endpoint, offering a statistically significant increase in the proportion of patients achieving a complete ALP level normalisation. Zydus has not yet shared the secondary endpoint data, but has announced plans to present it at an upcoming, unspecified scientific conference.
Following this trial outcome, Zydus’s chair Pankaj Patel noted that the company “intends to discuss these results with regulatory agencies”, while the pharma prepares to submit a new drug application (NDA) for saroglitazar to the FDA in Q1 2026.
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By GlobalDataFierce competition looms in PBC
Though Zydus obtained orphan drug designation from the FDA for saroglitazar in PBC during 2021, the drug has since been beaten to the market by two other PPAR agonists. This includes Gilead’s Livdelzi (seladelpar lysine), which was given the FDA green light for the indication in August 2024.
Though Zydus is yet to release the full details of saroglitazar’s efficacy, it is looking like Livdelzi may trump the former in this department, with the drug offering 62% of patients a composite biochemical response after a year of treatment.
Following its US market entry in this indication, analysts at GlobalData, parent company of Clinical Trials Arena, forecast that Gilead’s drug will hit blockbuster status in 2028 – with Livdelzi’s sales peaking in 2030 at $1.6bn.
If saroglitazar were to make it to market, it would also have to go up against Ipsen’s Iqirvo (elafibranor), which attained accelerated FDA approval for PBC in June 2024. Iqirvo showed a 51% biochemical response in patients, with GlobalData’s analysts predicting the drug to pull in $528m for Ipsen in 2031.
Zydus will also have to contend with Intercept Pharmaceuticals’ Ocaliva (obeticholic acid), which has been on the market since 2016 following its accelerated FDA approval.
However, the farnesoid X receptor (FXR) agonist’s commercial success currently lies in the balance, as the FDA restricted the drug’s use in patients with advanced cirrhosis of the liver. This decision was made after reports that Ocaliva was linked to serious liver injury in patients.
