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Drug ReportsCholic acid
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
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
CHOLBAMMirum PharmaceuticalsN-205750 RX2015-03-17
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
cholbamNew Drug Application2025-05-09
Indications
FDA
EMA
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
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 cirrhosisD008105—K74.33583522
Liver diseasesD008107EFO_0001421K70-K773923521
CholangitisD002761HP_0030151K83.02352515
FibrosisD005355——3241615
Liver cirrhosisD008103EFO_0001422K74.03141412
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81—5—3412
Fatty liverD005234EFO_0003934——5—2411
Type 2 diabetes mellitusD003924EFO_0001360E11222229
Diabetes mellitusD003920EFO_0000400E08-E13—34218
GallstonesD042882EFO_0004210———2417
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CholestasisD002779—K83.1—67—414
Healthy volunteers/patients———6—3—110
Intrahepatic cholestasisD002780———44—17
Colorectal neoplasmsD015179——142——5
Cerebrotendinous xanthomatosisD019294——111—25
XanthomatosisD014973——111—25
Hepatitis aD006506EFO_0007305B15—21—14
MalnutritionD044342EFO_0008572E40-E46211—14
Pregnancy complicationsD011248———12—13
Glucose intoleranceD018149HP_0000833R73.03111—13
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alcoholic fatty liverD005235—K70.0—1——23
Gastrointestinal diseasesD005767——13———3
Digestive system diseasesD004066EFO_0000405K92.913———3
Liver neoplasmsD008113EFO_1001513C22.0—1——12
LipodystrophyD008060—E88.1—2———2
LipomaD008067—D17.911———2
Rheumatoid arthritisD001172EFO_0000685M06.9—2———2
ArthritisD001168EFO_0005856M05-M14—2———2
Biliary tract diseasesD001660EFO_0009534K83.912———2
Barrett esophagusD001471EFO_0000280K22.7—1——12
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neurofibromatosis 1D009456—Q85.014————4
NeurofibromatosesD017253—Q85.004————4
NeurofibromaD009455EFO_0000622—4————4
HyperlipidemiasD006949EFO_0003774E78.51———12
Central nervous system neoplasmsD016543——1———12
AgingD000375GO_0007568R41.811———12
Clostridium infectionsD003015EFO_1000874A05.21———12
Colonic neoplasmsD003110—C181————1
Rectal neoplasmsD012004——1————1
EcholocationD004455——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 procedureD018729——————22
InfectionsD007239EFO_0000544—————22
Communicable diseasesD003141——————22
DermatitisD003872—L30.9————11
Brain neoplasmsD001932EFO_0003833C71————11
SarcomaD012509——————11
Germ cell and embryonal neoplasmsD009373——————11
MedulloblastomaD008527——————11
RetinoblastomaD012175——————11
Rhabdoid tumorD018335——————11
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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—
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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-ID81-25-4
RxCUI—
ChEMBL IDCHEMBL205596
ChEBI ID16359
PubChem CID221493
DrugBankDB02659
UNII ID—
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,328 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10,895 adverse events reported
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