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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 2023-03-13 |
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
38 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 3 | 5 | 1 | — | 3 | 12 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 6 | 1 | — | 2 | 9 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 5 | 1 | — | 2 | 8 |
| 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 |
Show 3 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 1 | 1 | — | — | 1 | 2 |
| Lipodystrophy | D008060 | — | E88.1 | — | 2 | — | — | — | 2 |
| Cleft palate | D002972 | EFO_0003920 | 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 | — | Q75.2 | 1 | 1 | — | — | — | 1 |
| Hiv | D006678 | — | O98.7 | — | 1 | — | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | 1 | — | — | — | 1 |
| Alcoholic fatty liver | D005235 | — | K70.0 | — | 1 | — | — | — | 1 |
Show 2 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | 1 | 3 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | — | — | 1 | 2 |
| 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 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 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 | — | L30.9 | — | — | — | — | 1 | 1 |
| Hepatitis c | D006526 | — | B19.2 | — | — | — | — | 1 | 1 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | — | — | — | 1 | 1 |
| Hepatitis | D006505 | — | 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 |
Show 5 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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 | — |
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 14,380 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
10,465 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use