Saroglitazar is under clinical development by Zydus Therapeutics and currently in Phase II for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). According to GlobalData, Phase II drugs for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Saroglitazar LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Saroglitazar overview

Saroglitazar (lipaglyn) is the first Glitazar having lipid and glucose lowering effects in one single molecule.It is administered through oral route and formulated in the form of tablets. Lipaglyn is indicated for the treatment of diabetic dyslipidemia or hypertriglyceridemia in patients with type II diabetes, not controlled by statins alone, and Type II Diabetes Mellitus as an add on therapy with Meformin.

Saroglitazar is under development for the treatment of HIV-associated lipodystrophy, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease, hypertriglyceridemia (TG>500), polycystic ovarian syndrome, alcoholic liver diseases including alcoholic fatty liver, alcoholic hepatitis, cholestasis and alcoholic cirrhosis. It is a new chemical entity (NCE).

Zydus Therapeutics overview

Zydus Therapeutics, a subsidiary of Zydus Lifesciences Ltd, is a clinical-stage bio-pharmaceutical company with focus on the research and development of transformative treatments for rare and serious liver diseases. The company is headquartered in Mercer, New Jersey, the US.

For a complete picture of Saroglitazar’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.