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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: 04 Mar 2024

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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 Gallstone therapies; Hepatoprotectants
  • 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 Alcoholic hepatitis; Biliary atresia; 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

  • 29 Feb 2024 FDA assigns PDUFA action date of 15/10/2024 for obeticholic acid for Primary biliary cirrhosis
  • 29 Feb 2024 US FDA accepts supplemental sNDA for obeticholic acid for the treatment of individuals with primary biliary cholangitis
  • 06 Feb 2024 Intercept Pharmaceuticals terminates a phase II trial in Primary biliary cirrhosis in USA, Austria, Canada, France, Germany, Netherlands, Spain and United Kingdom, due to administrative reasons (NCT00550862)
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