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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 G-protein coupled bile acid receptor 1 and bile acid receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
nervous system diseasesD009422
urogenital diseasesD000091642
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
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
CHOLBAMTravere TherapeuticsN-205750 RX2015-03-17
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
cholbamNew Drug Application2020-12-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
zellweger syndromeOrphanet_912D015211E71.510
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A05: Bile and liver therapy drugs
— A05A: Bile therapy drugs
— A05AA: Bile acids and derivatives for bile therapy
— A05AA03: Cholic acid
HCPCS
Code
Description
J0591
Injection, deoxycholic acid, 1 mg
Clinical
Clinical Trials
14 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Zellweger syndromeD015211Orphanet_912E71.510——1—12
Infantile refsum diseaseD052919Orphanet_772G60.1——1—12
AdrenoleukodystrophyD000326Orphanet_43E71.52——1—12
Liver diseasesD008107EFO_0001421K70-K771—1——2
CholestasisD002779K83.1——1——1
Peroxisomal disordersD018901EFO_0010956E71.5——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Smith-lemli-opitz syndromeD019082Orphanet_818E78.7211———1
End stage liver diseaseD058625EFO_1001311K72.1—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318EFO_0000319I981————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81————22
Chronic hepatitis cD019698EFO_0004220B18.2————11
Fontan procedureD018729————11
Liver cirrhosisD008103EFO_0001422K74.0————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCHOLIC 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
PDB6IE8
CAS-ID81-25-4
RxCUI1440856
ChEMBL IDCHEMBL205596
ChEBI ID16359
PubChem CID221493
DrugBankDB02659
UNII ID—
Target
Agency Approved
No data
Alternate
GPBAR1
GPBAR1
NR1H4
NR1H4
Organism
Homo sapiens
Gene name
GPBAR1
Gene synonyms
TGR5
NCBI Gene ID
151306
Protein name
G-protein coupled bile acid receptor 1
Protein synonyms
BG37, G-protein coupled bile acid receptor BG37, G-protein coupled receptor GPCR19, hBG37, hGPCR19, M-BAR, membrane bile acid receptor, Membrane-type receptor for bile acids
Uniprot ID
Q8TDU6
Mouse ortholog
Gpbar1 (227289)
G-protein coupled bile acid receptor 1 (Q80SS6)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 10,704 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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71,087 adverse events reported
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