Drug Profile


Alternative Names: MBX 8025; RWJ 800025

Latest Information Update: 13 Sep 2017

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At a glance

  • Originator Ortho-McNeil
  • Developer CymaBay Therapeutics
  • Class Acetates; Hepatoprotectants; Triazoles
  • Mechanism of Action C-reactive protein inhibitors; Peroxisome proliferator-activated receptor delta agonists
  • Orphan Drug Status

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

    Yes - Hyperlipoproteinaemia type V; Hyperlipoproteinaemia type I; Hyperlipoproteinaemia type IIa; Primary biliary cirrhosis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Hyperlipidaemia; Hyperlipoproteinaemia type IIa; Primary biliary cirrhosis
  • Preclinical Non-alcoholic steatohepatitis

Most Recent Events

  • 11 Sep 2017 Seladelpar receives Orphan Drug status for Primary biliary cirrhosis in European Union
  • 15 Aug 2017 CymaBay Therapeutics plans a phase III trial for Primary biliary cirrhosis
  • 17 Jul 2017 Interim efficacy and adverse event data from a phase II trial in Primary biliary cirrhosis released by CymaBay Therapeutics
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