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: 16 Sep 2025

Price :

$50 ^*

Note:

Adis is an information provider. We do not sell or distribute actual drugs.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase.
A link to download a PDF version of the drug profile will be included in your email receipt.

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

11 Sep 2025 Withdrawn for Primary biliary cirrhosis (Combination therapy, Treatment-experienced) in USA (PO)
11 Sep 2025 Withdrawn for Primary biliary cirrhosis (Monotherapy, Treatment-experienced) in USA (PO)
11 Sep 2025 The US FDA places a clinical hold on all clinical trials conducted under a US IND involving obeticholic acid

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial (opens in a new window)

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com