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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

Latest Information Update: 11 Nov 2021

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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 Anti-inflammatories; Antifibrotics; Antihyperglycaemics; Antihypertensives; Cholic acids; Cyclopentanes; Hepatoprotectants; Obesity therapies; 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
  • Preregistration Non-alcoholic steatohepatitis
  • Phase II Alcoholic hepatitis; Biliary atresia; Cholelithiasis; Obesity
  • Preclinical Reperfusion injury
  • No development reported Crohn's disease; Portal hypertension; Primary bile acid malabsorption
  • Discontinued Primary sclerosing cholangitis; Type 2 diabetes mellitus

Most Recent Events

  • 29 Jul 2021 Intercept Pharmaceuticals plans a pre-submission meeting with US FDA for Non-alcoholic steatohepatitis, in the first-half of 2022
  • 31 May 2021 Launched for Primary biliary cirrhosis (Combination therapy) in Canada (PO)
  • 31 May 2021 Launched for Primary biliary cirrhosis (Monotherapy) in Canada (PO)
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