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A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)

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Trial Profile

A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 05 Mar 2025

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At a glance

  • Drugs Seladelpar (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Pharmacodynamics; Proof of concept
  • Sponsors CymaBay Therapeutics; Gilead Sciences; Vitaflo

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.
  • 27 Jul 2020 This trial has been completed in United Kingdom, according to European Clinical Trials Database record.(Global end date: 2016-05-26)

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