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: 08 Dec 2017

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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

  • 01 Nov 2017 Intercept Pharmaceuticals announces intension to submit NDA to US FDA for Non-alcoholic steatohepatitis (In patients with cirrhosis)
  • 01 Nov 2017 Intercept Pharmaceuticals anticipates label update for obeticholic acid from the US FDA for Primary biliary cirrhosis by early 2018
  • 31 Jul 2017 Efficacy and adverse events data from the phase II CONTROL trial in Non-alcoholic steatohepatitis released by Intercept Pharmaceuticals
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