| Drug Name |
Obeticholic acid |
| Drug ID |
BADD_D01592 |
| Description |
Primary biliary cirrhosis, or PBC, is a progressive and chronic condition that leads to hepatic injury often resulting in end-stage liver failure that requires liver transplantation.[A192786]
Obeticholic acid is a farnesoid-X receptor (FXR) agonist used to treat this condition, possibly allowing for increased survival.[A18696] In 2016, it was granted approval to treat primary biliary cholangitis in combination with [ursodeoxycholic acid], which was previously the mainstay treatment for this condition.[A18696,L12633] In May 2021, the FDA updated its prescribing information to contraindicate the use of obeticholic acid in patients with PBC and advanced cirrhosis (e.g. those with portal hypertension or hepatic decompensation) due to a risk of liver failure, in some cases requiring liver transplantation.[L34650]
Obeticholic acid is currently being considered for FDA approval to treat fibrosis caused by non-alcoholic liver steatohepatitis (NASH). The NDA from Intercept Pharmaceuticals was approved in November 2019 and obeticholic acid is expected to be granted full approval for this indication in 2020.[L12636] |
| Indications and Usage |
Obeticholic acid was approved as an orphan drug based on its reduction in the level of the biomarker alkaline phosphatase as a surrogate endpoint for clinical benefit. It is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Additional studies are being required to prove its clinical benefit. |
| Marketing Status |
Prescription |
| ATC Code |
A05AA04 |
| DrugBank ID |
DB05990
|
| KEGG ID |
D09360
|
| MeSH ID |
C464660
|
| PubChem ID |
447715
|
| TTD Drug ID |
D0M4WA
|
| NDC Product Code |
73435-004; 63190-0840; 47848-056; 65089-0055; 0009-0098; 69766-066; 59285-028; 71796-004; 46708-923; 63190-0830; 69516-010; 68554-0121; 69516-005 |
| Synonyms |
obeticholic acid | 6ECDCA | cholan-24-oic acid, 6-ethyl-3,7-dihydroxy-, (3alpha,5beta,6alpha,7alpha)- | 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid | 6-ECDCA | 6alpha-ethyl-chenodeoxycholic acid | 6-ethyl-3,7-dihydroxycholan-24-oic acid | 6-ethyl chenodeoxycholic acid | 6-ethylchenodeoxycholic acid | DSP-1747 | DSP1747 | Ocaliva | INT 747 | INT747 | INT-747 |
