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Saroglitazar - Zydus Cadila

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Drug Profile

Saroglitazar - Zydus Cadila

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

Latest Information Update: 05 Jun 2026

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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
  • Preregistration Primary biliary cirrhosis
  • Phase III Lipodystrophy
  • Phase II Liver disorders; Polycystic ovary syndrome

Most Recent Events

  • 28 May 2026 Updated efficacy and adverse events data from the phase-II/III trial in Primary biliary cirrhosis released by Zydus Therapeutics
  • 28 May 2026 Preregistration for Primary biliary cirrhosis (Treatment-experienced) in USA (PO)
  • 28 May 2026 FDA assigns PDUFA action date of 27/11/2026 for Saroglitazar for Primary biliary cirrhosis

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