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An 8-week, Dose Ranging, Open Label, Randomized, Phase 2 Study With a 44-week Extension, to Evaluate the Safety and Efficacy of MBX-8025 in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or Intolerance to Ursodeoxycholic Acid (UDCA)

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An 8-week, Dose Ranging, Open Label, Randomized, Phase 2 Study With a 44-week Extension, to Evaluate the Safety and Efficacy of MBX-8025 in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or Intolerance to Ursodeoxycholic Acid (UDCA)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Feb 2024

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At a glance

  • Drugs Seladelpar (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors CymaBay Therapeutics

    • Most Recent Events

    • 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.
    • 12 Feb 2024 According to a CymaBay Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for seladelpar for the management of primary biliary cholangitis including pruritus in adults without cirrhosis or with compensated cirrhosis who are inadequate responders or intolerant to ursodeoxycholic acid.The NDA includes data from across Phase 3 RESPONSE, ENHANCE and ASSURE study and prior Phase 2 studies.
    • 10 Nov 2022 According to a CymaBay Therapeutics media release, pooled data from this and NCT02955602 were presented at The Liver Meeting of the American Association for the Study of Liver Diseases (AASLD) 2022.

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