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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Nov 2024

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At a glance

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

    • Most Recent Events

    • 15 Nov 2024 Results of two oral presentations, A prespecified subgroup analysis and A secondary analysis of pruritus, highlighting additional analyses from the Phase 3 RESPONSE trial presented in a Gilead Sciences media release.
    • 22 Oct 2024 According to a Gilead Sciences Media Release, the efficacy and safety data including secondary analysis of patterns of Pruritis, reduction in Lipids from this trial will be presented at The Liver Meeting 2024, hosted by the American Association for the Study of Liver Diseases (AASLD) from November 15-19 in San Diego, Calif.
    • 14 Aug 2024 According to Gilead Sciences media release, company announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA

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