Drug Profile

Obeticholic acid - Intercept Pharmaceuticals

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

Latest Information Update: 03 Dec 2024

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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; Gallstone therapies; 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

Marketed Primary biliary cirrhosis
Preregistration Non-alcoholic steatohepatitis
Phase II/III Biliary atresia
Phase II Alcoholic hepatitis; Cholelithiasis; Obesity
No development reported Crohn's disease; Portal hypertension; Primary bile acid malabsorption; Reperfusion injury
Discontinued Primary sclerosing cholangitis; Type 2 diabetes mellitus

27 Nov 2024 The General Court of the European Union has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorisation (CMA) of obeticholic acid for Primary biliary cirrhosis (Second line therapy or greater) in Europe
12 Nov 2024 Intercept Pharmaceuticals receives complete response letter from the US FDA for Obeticholic acid in Primary biliary cholangitis
17 Oct 2024 Intercept Pharmaceuticals receives a response from the US FDA for delay in sNDA review for Obeticholic acid in Primary biliary cirrhosis

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