Drug Profile
Obeticholic acid - Intercept Pharmaceuticals
Alternative Names: 6-ECDCA; 6-ethyl-chenodeoxycholic-acid; DSP-1747; INT-747; OCA; Ocaliva; Zektayos-HepjuvoLatest Information Update: 04 Mar 2024
Price :
$50
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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 Gallstone therapies; Hepatoprotectants
- Mechanism of Action Farnesoid X-activated receptor agonists
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Primary biliary cirrhosis
- Preregistration Non-alcoholic steatohepatitis
- Phase II Alcoholic hepatitis; Biliary atresia; Cholelithiasis; Obesity
- No development reported Crohn's disease; Portal hypertension; Primary bile acid malabsorption; Reperfusion injury
- Discontinued Primary sclerosing cholangitis; Type 2 diabetes mellitus
Most Recent Events
- 29 Feb 2024 FDA assigns PDUFA action date of 15/10/2024 for obeticholic acid for Primary biliary cirrhosis
- 29 Feb 2024 US FDA accepts supplemental sNDA for obeticholic acid for the treatment of individuals with primary biliary cholangitis
- 06 Feb 2024 Intercept Pharmaceuticals terminates a phase II trial in Primary biliary cirrhosis in USA, Austria, Canada, France, Germany, Netherlands, Spain and United Kingdom, due to administrative reasons (NCT00550862)