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A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis

Trial Profile

A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Nov 2019

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At a glance

  • Drugs Obeticholic acid (Primary)
  • Indications Hepatic fibrosis; Non-alcoholic steatohepatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms REGENERATE
  • Sponsors Intercept Pharmaceuticals
  • Most Recent Events

    • 28 Oct 2019 According to an Intercept Pharmaceuticals media release, data from interim analysis will be presented at at The Liver Meeting 2019, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place from November 8, 2019 through November 12, 2019 in Boston, Massachusetts.
    • 27 Sep 2019 Results published in Intercept Pharmaceuticals Media Release
    • 27 Sep 2019 According to an Intercept Pharmaceuticals media release, the company has requested a Priority Review for the NDA, which, if granted, would result in an anticipated six-month review period.
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