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Obeticholic acid - Intercept Pharmaceuticals

Drug Profile

Obeticholic acid - Intercept Pharmaceuticals

Alternative Names: 6-ECDCA; 6-ethyl-chenodeoxycholic-acid; DSP-1747; INT-747; OCA; Ocaliva; Zektayos-Hepjuvo

Latest Information Update: 23 Jun 2026

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At a glance

  • Originator GlaxoSmithKline; Universita degli Studi di Perugia
  • Developer Imperial College of Science, Technology and Medicine; Indiana University; Intercept Pharmaceuticals; National Institute on Alcohol Abuse and Alcoholism; Sahlgrenska University Hospital; Sumitomo Dainippon Pharma
  • Class Anti-inflammatories; Antifibrotics; Antihyperglycaemics; Antihypertensives; Cholic acids; Cyclopentanes; Gallstone therapies; Hepatoprotectants; Obesity therapies; Pentanoic acids; Phenanthrenes; Small molecules
  • Mechanism of Action Farnesoid X-activated receptor agonists
  • Orphan Drug Status

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

    Yes - Primary sclerosing cholangitis; Primary biliary cirrhosis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Primary biliary cirrhosis
  • Preregistration Non-alcoholic steatohepatitis
  • Phase II/III Biliary atresia
  • Phase II Alcoholic hepatitis; Cholelithiasis; Obesity
  • No development reported Crohn's disease; Portal hypertension; Primary bile acid malabsorption; Reperfusion injury
  • Discontinued Primary sclerosing cholangitis; Type 2 diabetes mellitus

Most Recent Events

  • 31 Oct 2025 Intercept Pharmaceuticals terminates a phase II/III trial in Biliary atresia (In neonates, In infants, In children, In adolescents) in Australia, Belgium, Canada, China, France, Germany, Hong Kong, Israel, Italy, Malaysia, Netherlands, New Zealand, Poland, Singapore, Spain, Taiwan, Turkey, United Kingdom, Vietnam (PO) based on FDA's request for voluntary withdrawal of Ocaliva (NCT06121375)
  • 11 Sep 2025 Withdrawn for Primary biliary cirrhosis (Combination therapy, Treatment-experienced) in USA (PO)
  • 11 Sep 2025 Withdrawn for Primary biliary cirrhosis (Monotherapy, Treatment-experienced) in USA (PO)

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