Obeticholic acid

Drug Profile

Obeticholic acid

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

Latest Information Update: 03 Mar 2017

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

  • 01 Mar 2017 NICE approves obeticholic acid for Primary biliary cirrhosis in England, Wales and Northern Ireland
  • 01 Mar 2017 Adverse events data in Primary biliary cirrhosis released by Intercept
  • 14 Dec 2016 Registered for Primary biliary cirrhosis (Combination therapy) in Liechtenstein, Norway, Iceland, European Union (PO)
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