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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: 15 Nov 2019

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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; 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; Primary sclerosing cholangitis
  • Preclinical Reperfusion injury
  • No development reported Crohn's disease; Portal hypertension; Primary bile acid malabsorption
  • Discontinued Type 2 diabetes mellitus

Most Recent Events

  • 05 Nov 2019 Intercept Pharmaceuticals plans to launch obeticholic acid for Nonalcoholic steatohepatitis
  • 27 Sep 2019 Preregistration for Non-alcoholic steatohepatitis in USA (PO)
  • 07 Aug 2019 Intercept Pharmaceuticals announces intention to submit MAA to EMA for Non-alcoholic steatohepatitis in fourth quarter of 2019
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