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A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

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A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 13 Aug 2024

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At a glance

  • Drugs Seladelpar (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ENHANCE
  • Sponsors CymaBay Therapeutics

    • Most Recent Events

    • 04 Mar 2024 According to a CymaBay Therapeutics media release, the Marketing Authorization Application (MAA) for seladelpar, for the treatment of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid), has been validated and will now be reviewed by the European Medicines Agency (EMA).
    • 04 Mar 2024 According to a CymaBay Therapeutics media release, the MAA application includes data from global Phase 3 RESPONSE study, The application is further supported by data from the Phase 3 ENHANCE study, the long-term open label ASSURE study, Phase 2 studies, pre-clinical studies and includes chemistry, manufacturing, and controls data.
    • 12 Feb 2024 According to a CymaBay Therapeutics media release, the FDA has granted priority review and set a Prescription Drug User Fee Act (PDUFA) target action date of August 14, 2024 and notified the company that it is not currently planning to hold an advisory committee meeting to discuss the application.

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