| Pharmaceutical Information |
| 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 is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA. It is also used as a monotherapy in adults with PBC that are unable to tolerate UDCA.[L12633]
Obeticholic acid is currently being considered for FDA approval to treat fibrosis caused by non-alcoholic liver steatohepatitis (NASH), and is likely to be approved for this indication in 2020.[L12636] |
| Marketing Status |
approved |
| ATC Code |
A05AA04 |
| DrugBank ID |
DB05990
|
| KEGG ID |
D09360
|
| MeSH ID |
C464660
|
| PubChem ID |
447715
|
| TTD Drug ID |
D0M4WA
|
| NDC Product Code |
69516-010; 65089-0055; 68554-0121; 47848-056; 73435-004; 69516-005; 63190-0840; 69766-066; 71796-004; 59285-028; 0009-0098; 63190-0830 |
| UNII |
0462Z4S4OZ
|
| 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 |
|
| Chemical Information |
| Molecular Formula |
C26H44O4 |
| CAS Registry Number |
459789-99-2 |
| SMILES |
CCC1C2CC(CCC2(C3CCC4(C(C3C1O)CCC4C(C)CCC(=O)O)C)C)O |
| Chemical Structure |
|
|
| ADRs Induced by Drug |
|
|
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
|
|
|
