Cholbam, Orphacol(cholic acid)
Cholbam, Orphacol (cholic acid) is a small molecule pharmaceutical. Cholic acid was first approved as Orphacol on 2013-09-12. It is used to treat zellweger syndrome in the USA. It has been approved in Europe to treat digestive system diseases and inborn errors metabolism. It is known to target bile acid receptor and G-protein coupled bile acid receptor 1.
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Commercial
Trade Name
FDA
EMA
Cholbam
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cholic acid
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CHOLBAM | Travere Therapeutics | N-205750 RX | 2015-03-17 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cholbam | New Drug Application | 2023-03-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| zellweger syndrome | Orphanet_912 | D015211 | E71.510 |
| inborn errors metabolism | — | D008661 | — |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J0591 | Injection, deoxycholic acid, 1 mg |
Clinical
Clinical Trials
34 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 3 | 5 | 1 | — | 3 | 12 |
| Peroxisomal disorders | D018901 | Orphanet_44 | E71.5 | — | — | 1 | — | 1 | 2 |
| Zellweger syndrome | D015211 | Orphanet_912 | E71.510 | — | — | 1 | — | 1 | 2 |
| Infantile refsum disease | D052919 | Orphanet_772 | G60.1 | — | — | 1 | — | 1 | 2 |
| Adrenoleukodystrophy | D000326 | Orphanet_43 | E71.52 | — | — | 1 | — | 1 | 2 |
| Refsum disease | D012035 | Orphanet_773 | G60.1 | — | — | 1 | — | 1 | 2 |
| Inborn errors metabolism | D008661 | — | — | — | — | 1 | — | — | 1 |
| Inborn errors lipid metabolism | D008052 | — | — | — | — | 1 | — | — | 1 |
| Inborn errors steroid metabolism | D043202 | — | — | — | — | 1 | — | — | 1 |
| Cholestasis | D002779 | HP_0001396 | K83.1 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatty liver | D005234 | EFO_0003934 | — | — | 5 | — | — | 2 | 7 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 4 | — | — | 2 | 6 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | 1 | 2 |
| Lipodystrophy | D008060 | HP_0009125 | E88.1 | — | 2 | — | — | — | 2 |
| Cleft palate | D002972 | HP_0000175 | Q35 | 1 | 1 | — | — | — | 1 |
| Hypospadias | D007021 | EFO_0004209 | Q54 | 1 | 1 | — | — | — | 1 |
| X-linked genetic diseases | D040181 | — | — | 1 | 1 | — | — | — | 1 |
| Smith-lemli-opitz syndrome | D019082 | Orphanet_818 | E78.72 | 1 | 1 | — | — | — | 1 |
| Hypertelorism | D006972 | HP_0000316 | Q75.2 | 1 | 1 | — | — | — | 1 |
| Hiv | D006678 | — | — | — | 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 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Alcoholic hepatitis | D006519 | EFO_1001345 | K70.1 | 1 | — | — | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | — | — | — | 1 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | — | — | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | — | — | — | 1 | 1 |
| Hepatitis c | D006526 | — | B19.2 | — | — | — | — | 1 | 1 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | — | — | — | 1 | 1 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | — | — | — | — | 1 | 1 |
| Appetite regulation | D001069 | — | — | — | — | — | — | 1 | 1 |
| Metabolism | D008660 | GO_0008152 | — | — | — | — | — | 1 | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 1 | 1 |
| Fontan procedure | D018729 | — | — | — | — | — | — | 1 | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cholic acid |
| INN | — |
| Description | Cholic acid is a bile acid that is 5beta-cholan-24-oic acid bearing three alpha-hydroxy substituents at position 3, 7 and 12. It has a role as a human metabolite and a mouse metabolite. It is a bile acid, a C24-steroid, a 3alpha-hydroxy steroid, a 7alpha-hydroxy steroid, a 12alpha-hydroxy steroid and a trihydroxy-5beta-cholanic acid. It is a conjugate acid of a cholate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H](CCC(=O)O)[C@H]1CC[C@H]2[C@H]3[C@H](C[C@H](O)[C@@]21C)[C@@]1(C)CC[C@@H](O)C[C@H]1C[C@H]3O |
Identifiers
| PDB | — |
| CAS-ID | 81-25-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL205596 |
| ChEBI ID | 16359 |
| PubChem CID | 221493 |
| DrugBank | DB02659 |
| UNII ID | — |
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Safety
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9,973 adverse events reported
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