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Seladelpar - CymaBay Therapeutics

Drug Profile

Seladelpar - CymaBay Therapeutics

Alternative Names: MBX 8025; RWJ 800025

Latest Information Update: 18 Aug 2022

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At a glance

  • Originator Ortho-McNeil
  • Developer CymaBay Therapeutics
  • Class Acetates; Anti-inflammatories; Antifibrotics; Antihyperlipidaemics; Hepatoprotectants; Small molecules
  • 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; Primary sclerosing cholangitis
  • Phase I Liver disorders

Most Recent Events

  • 11 Aug 2022 CymaBay Therapeutics completes enrolment in its phase III RESPONSE trial for Primary biliary cirrhosis in the US, Australia, Belgium, France, Germany, Greece, Hungary, Israel, Italy, South Korea, Netherlands, New Zealand, Poland, Russia, Spain, Argentina, Canada, Chile, Mexico, Romania, and the UK (NCT04620733) (EudraCT2020-004348-27)
  • 01 Aug 2022 CymaBay Therapeutics completes enrollment in the phase III RESPONSE trial of seladelpar for patients with Primary biliary cholangitis in USA, Australia, Belgium, France, Germany, Greece, Hungary, Israel, Italy, South Korea, Netherlands, New Zealand, Poland, Russia, Spain, Argentina, Canada, Chile, Mexico, Romania, and the UK (PO)
  • 22 Jun 2022 Pharmacodynamics data from a preclinical trial in liver disorders were presented at The International Liver Congress 2022 (ILC-2022)
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