Obeticholic acid - Intercept Pharmaceuticals

Drug Profile

Obeticholic acid - Intercept Pharmaceuticals

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

Latest Information Update: 07 Aug 2018

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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 Cholic acids; Cyclopentanes; 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
  • Phase III Non-alcoholic steatohepatitis
  • Phase II Alcoholic hepatitis; Biliary atresia; Cholelithiasis; Obesity; Primary sclerosing cholangitis
  • No development reported Crohn's disease; Portal hypertension; Primary bile acid malabsorption
  • Discontinued Type 2 diabetes mellitus

Most Recent Events

  • 14 May 2018 Discontinued - Phase-I for Primary biliary cirrhosis in Japan (PO)
  • 13 Apr 2018 Adverse events and efficacy data from a substudy from the phase III POISE in Primary biliary cirrhosis presented at the 53rd Annual Meeting of the European Association for the Study of the Liver (EASL-2018)
  • 13 Apr 2018 Pooled efficacy data from the phase III POISE and two phase II trials in Primary biliary cirrhosis presented at the 53rd Annual Meeting of the European Association for the Study of the Liver (EASL-2018)
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