Sotagliflozin is under clinical development by Lexicon Pharmaceuticals and currently in Phase III for Type 2 Diabetes. According to GlobalData, Phase III drugs for Type 2 Diabetes have a 52% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Sotagliflozin’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. 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.

Sotagliflozin overview

Sotagliflozin (Zynquista, Inpefa) is a potential antihyperglycemic agent. It is formulated as film coated tablets for oral route of administration. Zynquista is indicated as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.

Sotagliflozin (LX4211, SAR-439954) is under development for the treatment of type 2 diabetes, diabetic kidney disease and hypertrophic cardiomyopathy. It was also under development for the treatment of type 1 diabetes who have CKD and worsening of heart failure in diabetic patients in the US.

Lexicon Pharmaceuticals overview

Lexicon Pharmaceuticals (Lexicon) is a biopharmaceutical company, which focuses on the discovery, development and commercialization of innovative treatments for human diseases. The company engaged in the development of sotagliflozin in type 1 diabetes, which was the subject of a separate NDA, in which NDA is in positive results of the third phase clinical trials evaluating the effect of sotagliflozin on type 1 diabetes in approximately 800, 800 and 1,400 patients. The company has advanced multiple drug candidates into clinical development and has clinical-stage drug program sotagliflozin for heart failure and type 1 diabetes. Its clinical and preclinical development programs, LX9211, are meant for the treatment of diabetes and neuropathic pain, respectively. It has business collaborations with several pharmaceutical and biotechnology companies. The company operates an office in New Jersey and has a laboratory in Texas. Lexicon is headquartered at The Woodlands, Texas, the US.

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

This content was updated on 18 March 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.