Ocaliva(obeticholic acid)
Obeticholic Acid, Ocaliva (obeticholic acid) is a small molecule pharmaceutical. Obeticholic acid was first approved as Ocaliva on 2016-05-27. It is used to treat cholangitis in the USA. It has been approved in Europe to treat biliary liver cirrhosis. The pharmaceutical is active against bile acid receptor.
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Commercial
Therapeutic Areas
Trade Name
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EMA
Ocaliva (discontinued: Obeticholic acid)
Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Obeticholic acid
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OCALIVA | Intercept Pharmaceuticals | N-207999 RX | 2016-05-27 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ocaliva | New Drug Application | 2022-10-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cholangitis | HP_0030151 | D002761 | K83.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
OBETICHOLIC ACID, OCALIVA, INTERCEPT PHARMS INC | |||
| 2023-05-27 | ODE-119 | ||
HCPCS
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Clinical
Clinical Trials
41 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biliary liver cirrhosis | D008105 | — | K74.3 | 1 | 6 | 4 | 2 | 4 | 17 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | — | 4 | 2 | 2 | 4 | 12 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 3 | 3 | 2 | — | 8 |
| Fibrosis | D005355 | — | — | — | 3 | 3 | 2 | — | 8 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatty liver | D005234 | EFO_0003934 | — | — | 4 | 2 | — | 1 | 7 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 3 | 2 | — | 1 | 6 |
| Biliary atresia | D001656 | EFO_0004217 | Q44.2 | — | 2 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | 1 | — | — | 1 | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 1 | — | — | — | 2 |
| Lipodystrophy | D008060 | HP_0009125 | E88.1 | — | 1 | — | — | — | 1 |
| Familial partial lipodystrophy | D052496 | — | — | — | 1 | — | — | — | 1 |
| Gallstones | D042882 | EFO_0004210 | — | — | 1 | — | — | — | 1 |
| Cholelithiasis | D002769 | EFO_0004799 | K80 | — | 1 | — | — | — | 1 |
| Cholecystolithiasis | D041761 | EFO_1000864 | — | — | 1 | — | — | — | 1 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | 1 | — | — | — | 1 |
| Malabsorption syndromes | D008286 | EFO_0009554 | K90 | — | 1 | — | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | 1 | 3 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Cholestasis | D002779 | HP_0001396 | K83.1 | 1 | — | — | — | — | 1 |
| Pruritus | D011537 | HP_0000989 | L29 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcohol drinking | D000428 | EFO_0004329 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Obeticholic acid |
| INN | obeticholic acid |
| Description | Obeticholic acid is a dihydroxy-5beta-cholanic acid that is chenodeoxycholic acid carrying an additional ethyl substituent at the 6alpha-position. A semi-synthetic bile acid which acts as a farnesoid X receptor agonist and is used for treatment of primary biliary cholangitis. It has a role as a farnesoid X receptor agonist and a hepatoprotective agent. It is a dihydroxy-5beta-cholanic acid, a 3alpha-hydroxy steroid and a 7alpha-hydroxy steroid. It is functionally related to a chenodeoxycholic acid. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@@H]1[C@@H]2C[C@H](O)CC[C@]2(C)[C@H]2CC[C@@]3(C)[C@@H](CC[C@@H]3[C@H](C)CCC(=O)O)[C@@H]2[C@@H]1O |
Identifiers
| PDB | — |
| CAS-ID | 459789-99-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL566315 |
| ChEBI ID | — |
| PubChem CID | 447715 |
| DrugBank | DB05990 |
| UNII ID | 0462Z4S4OZ (ChemIDplus, GSRS) |
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Ocaliva – Intercept Pharmaceuticals
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Additional graphs summarizing 3,679 documents
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Safety
Black-box Warning
Black-box warning for: Ocaliva
Adverse Events
Top Adverse Reactions
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6,089 adverse events reported
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