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Saroglitazar - Zydus Cadila

Drug Profile

Saroglitazar - Zydus Cadila

Alternative Names: [14C] saroglitazar; [14C]-Saroglitazar; Bilypsa; Lipaglyn; Saroglitazar Magnesium; Saroglitazar Mg; ZY-H1

Latest Information Update: 28 May 2024

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At a glance

  • Originator Zydus-Cadila
  • Developer Zydus Cadila; Zydus Discovery DMCC
  • Class Antihyperglycaemics; Antihyperlipidaemics; Carboxylic acids; Hepatoprotectants; Propionic acids; Pyrroles; Small molecules
  • Mechanism of Action Peroxisome proliferator-activated receptor alpha agonists; Peroxisome proliferator-activated receptor gamma agonists
  • Orphan Drug Status

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

    Yes - Primary biliary cirrhosis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Dyslipidaemias; Hypertriglyceridaemia
  • Registered Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis; Type 2 diabetes mellitus
  • Phase III Lipodystrophy; Primary biliary cirrhosis
  • Phase II Liver disorders; Polycystic ovary syndrome

Most Recent Events

  • 15 May 2024 Zydus Therapeutics plans a phase III trial for Primary biliary cirrhosis in USA, Argentina, Turkey in May 2024 (PO, Tablet) (NCT06427395)
  • 06 Nov 2023 Lupin and Zydus Biosciences agree to co-promote Saroglitazar in India for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis
  • 04 Nov 2022 Efficacy data from a phase II trial in Non-alcoholic fatty liver disease presented at the 73rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2022)
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