Saroglitazar is under clinical development by Zydus Lifesciences and currently in Phase I for Cholestasis. According to GlobalData, Phase I drugs for Cholestasis does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Saroglitazar LoA Report. Buy the report here.

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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 Lifesciences overview

Zydus Lifesciences formerly Cadila Healthcare Ltd, is an integrated global healthcare provider. It discovers, develops, manufactures and commercializes various healthcare products. The company’s product portfolio includes active pharmaceutical ingredients (APIs), formulations, wellness and animal health products. Zydus Lifesciences products find application in the treatment of diseases in the therapeutic areas of gastrointestinal, cardiovascular, respiratory, pain management, cancer, inflammation, neurology, and women’s health, among others. It conducts research to develop biologics, biosimilars, vaccines and new chemical entities. The company has manufacturing facilities in Gujarat, Goa, Maharashtra, Sikkim and Himachal Pradesh in India; Brazil and the US. It has presence in the US, Europe, South Africa, Japan, Brazil, and other emerging markets. Zydus Lifesciences is headquartered in Ahmedabad, Gujarat, India.

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

This content was updated on 7 February 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.