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Seladelpar - CymaBay Therapeutics

Drug Profile

Seladelpar - CymaBay Therapeutics

Alternative Names: MBX 8025; RWJ 800025

Latest Information Update: 18 Feb 2019

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At a glance

  • Originator Ortho-McNeil
  • Developer CymaBay Therapeutics
  • Class Acetates; Anti-inflammatories; Antihyperlipidaemics; Hepatoprotectants
  • 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 III Primary biliary cirrhosis
  • Phase II Hyperlipidaemia; Hyperlipoproteinaemia type IIa; Non-alcoholic steatohepatitis

Most Recent Events

  • 15 Feb 2019 Seladelpar - CymaBay Therapeutics receives Breakthrough Therapy status for Primary biliary cirrhosis (Treatment-experienced) in USA
  • 13 Nov 2018 Updated efficacy and safety data from a phase II trial in Primary biliary cholangitis released by CymaBay Therapeutics
  • 30 Oct 2018 CymaBay Therapeutics plans to initiate an extension trial for phase III ENHANCE trial in Primary biliary cholangitis (PO)
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