Obeticholic acid

Drug Profile

Obeticholic acid

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

Latest Information Update: 19 Dec 2016

Price : $50

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; Pentanoic acids; 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Primary sclerosing cholangitis
  • 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 Dec 2016 Registered for Primary biliary cirrhosis (Combination therapy) in Liechtenstein, Norway, Iceland, European Union (PO)
  • 14 Dec 2016 Registered for Primary biliary cirrhosis (Monotherapy) in Norway, Liechtenstein, Iceland, European Union (PO)
  • 11 Nov 2016 Exploratory efficacy data from the phase III POISE trial in Primary biliary cirrhosis presented at the 67th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD - 2016)
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