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Sotagliflozin - Lexicon Pharmaceuticals

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Drug Profile

Sotagliflozin - Lexicon Pharmaceuticals

Alternative Names: INPEFA; LP-802034; LX-4211; SAR 439954; Zynquista

Latest Information Update: 20 Mar 2025

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At a glance

  • Originator Lexicon Pharmaceuticals
  • Developer Lexicon Pharmaceuticals; Sanofi
  • Class Alcohols; Antihyperglycaemics; Chlorobenzenes; Glycosides; Heart failure therapies; Phenyl ethers; Pyrans; Small molecules; Sulfhydryl compounds
  • Mechanism of Action Sodium-glucose transporter 1 inhibitors; Sodium-glucose transporter 2 inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Heart failure; Type 2 diabetes mellitus
  • Registered Type 1 diabetes mellitus
  • Phase III Hypertrophic cardiomyopathy

Most Recent Events

  • 06 Mar 2025 Discontinued - Preregistration for Type 1 diabetes mellitus (Adjunctive treatment) in USA (PO)
  • 20 Dec 2024 Lexicon Pharmaceuticals receives a complete response letter (CRL) from the US FDA regarding the New Drug Application (NDA) for sotagliflozin in Type 1 diabetes mellitus and chronic kidney disease
  • 22 Nov 2024 Lexicon Pharmaceuticals receives deficiencies preclude discussion letter from the US FDA for sotagliflozin in Type 1 diabetes mellitus

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