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Bezafibrate/obeticholic acid - Intercept Pharmaceuticals

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Drug Profile

Bezafibrate/obeticholic acid - Intercept Pharmaceuticals

Alternative Names: Bezafibrate/OCA - Intercept Pharmaceuticals; Obeticholic acid/bezafibrate - Intercept Pharmaceuticals; OCA/bezafibrate - Intercept Pharmaceuticals

Latest Information Update: 10 Nov 2025

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At a glance

  • Originator Intercept Pharmaceuticals
  • Class Anti-inflammatories; Antifibrotics; Antihyperlipidaemics; Benzamides; Cholic acids; Cyclopentanes; Fibric acid derivatives; Hepatoprotectants; Pentanoic acids; Phenanthrenes; Phenylbutyrates; Small molecules
  • Mechanism of Action Farnesoid X-activated receptor agonists; Peroxisome proliferator-activated receptor alpha agonists; Peroxisome proliferator-activated receptor delta agonists; Peroxisome proliferator-activated receptor gamma agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Primary biliary cirrhosis
  • New Molecular Entity No

Highest Development Phases

  • Phase III Primary biliary cirrhosis

Most Recent Events

  • 31 Oct 2025 Intercept Pharmaceuticals terminates a phase III trial in Primary biliary cirrhosis in USA, Argentina, Australia, Belgium, Canada, Croatia, Czechia, Estonia, France, Germany, Greece, Hungary, Israel, Italy, South Korea, Lithuania, Netherlands, Norway, Spain, Turkey, United Kingdom (PO) (NCT06488911)
  • 15 Nov 2024 Efficacy, adverse events and pharmacokinetics data from a phase I trial in Primary biliary cirrhosis presented at the The Liver Meeting 2024: 75th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2024)
  • 01 Jul 2024 Phase-III clinical trials in Primary biliary cirrhosis in USA, United Kingdom, Lithuania, Turkey, Spain, Norway, Netherlands, South Korea, Italy, Israel, Hungary, Greece, Germany, France, Estonia, Czech Republic, Croatia, Canada, Belgium, Australia, Argentina (PO) (NCT06488911)

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