Cholbam, Kolbam (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 | Mirum Pharmaceuticals | N-205750 RX | 2015-03-17 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cholbam | New Drug Application | 2025-05-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| zellweger syndrome | Orphanet_912 | D015211 | E71.510 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0591 | Injection, deoxycholic acid, 1 mg |
Clinical
Clinical Trials
201 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 | 3 | 5 | 8 | 3 | 5 | 22 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 3 | 9 | 2 | 3 | 5 | 21 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | 2 | 3 | 5 | 2 | 5 | 15 |
| Fibrosis | D005355 | — | — | 3 | 2 | 4 | 1 | 6 | 15 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 3 | 1 | 4 | 1 | 4 | 12 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 5 | — | 3 | 4 | 12 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 5 | — | 2 | 4 | 11 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 2 | 2 | 2 | 2 | 2 | 9 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 3 | 4 | 2 | 1 | 8 |
| Gallstones | D042882 | EFO_0004210 | — | — | — | 2 | 4 | 1 | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cholestasis | D002779 | — | K83.1 | — | 6 | 7 | — | 4 | 14 |
| Healthy volunteers/patients | — | — | — | 6 | — | 3 | — | 1 | 10 |
| Intrahepatic cholestasis | D002780 | — | — | — | 4 | 4 | — | 1 | 7 |
| Colorectal neoplasms | D015179 | — | — | 1 | 4 | 2 | — | — | 5 |
| Cerebrotendinous xanthomatosis | D019294 | — | — | 1 | 1 | 1 | — | 2 | 5 |
| Xanthomatosis | D014973 | — | — | 1 | 1 | 1 | — | 2 | 5 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | — | 2 | 1 | — | 1 | 4 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | 1 | 1 | — | 1 | 4 |
| Pregnancy complications | D011248 | — | — | — | 1 | 2 | — | 1 | 3 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | 1 | 1 | 1 | — | 1 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcoholic fatty liver | D005235 | — | K70.0 | — | 1 | — | — | 2 | 3 |
| Gastrointestinal diseases | D005767 | — | — | 1 | 3 | — | — | — | 3 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | 1 | 3 | — | — | — | 3 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | — | — | 1 | 2 |
| Lipodystrophy | D008060 | — | E88.1 | — | 2 | — | — | — | 2 |
| Lipoma | D008067 | — | D17.9 | 1 | 1 | — | — | — | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 2 | — | — | — | 2 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | 2 | — | — | — | 2 |
| Biliary tract diseases | D001660 | EFO_0009534 | K83.9 | 1 | 2 | — | — | — | 2 |
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | — | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neurofibromatosis 1 | D009456 | — | Q85.01 | 4 | — | — | — | — | 4 |
| Neurofibromatoses | D017253 | — | Q85.00 | 4 | — | — | — | — | 4 |
| Neurofibroma | D009455 | EFO_0000622 | — | 4 | — | — | — | — | 4 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 1 | — | — | — | 1 | 2 |
| Central nervous system neoplasms | D016543 | — | — | 1 | — | — | — | 1 | 2 |
| Aging | D000375 | GO_0007568 | R41.81 | 1 | — | — | — | 1 | 2 |
| Clostridium infections | D003015 | EFO_1000874 | A05.2 | 1 | — | — | — | 1 | 2 |
| Colonic neoplasms | D003110 | — | C18 | 1 | — | — | — | — | 1 |
| Rectal neoplasms | D012004 | — | — | 1 | — | — | — | — | 1 |
| Echolocation | D004455 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fontan procedure | D018729 | — | — | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 2 | 2 |
| Dermatitis | D003872 | — | L30.9 | — | — | — | — | 1 | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | — | — | 1 | 1 |
| Sarcoma | D012509 | — | — | — | — | — | — | 1 | 1 |
| Germ cell and embryonal neoplasms | D009373 | — | — | — | — | — | — | 1 | 1 |
| Medulloblastoma | D008527 | — | — | — | — | — | — | 1 | 1 |
| Retinoblastoma | D012175 | — | — | — | — | — | — | 1 | 1 |
| Rhabdoid tumor | D018335 | — | — | — | — | — | — | 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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10,895 adverse events reported
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