cholic acid Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
3096 81-25-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • orphacol
  • cholic acid
  • cholalic acid
  • cholalin
  • colalin
  • kolbam
  • cholbam
A major primary bile acid produced in the liver and usually conjugated with glycine or taurine. It facilitates fat absorption and cholesterol excretion.
  • Molecular weight: 408.58
  • Formula: C24H40O5
  • CLOGP: 2.43
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 4
  • TPSA: 97.99
  • ALOGS: -3.74
  • ROTB: 4

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 12, 2013 EMA Laboratoires CTRS
March 17, 2015 FDA RTRX

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Seizure 12.64 0 3 10 24463 2333609

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event

Pharmacologic Action:

SourceCodeDescription
ATC A05AA03 ALIMENTARY TRACT AND METABOLISM
BILE AND LIVER THERAPY
BILE THERAPY
Bile acids and derivatives
FDA EPC N0000175802 Bile Acid
FDA CS M0002475 Bile Acids and Salts

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Constipation indication 14760008 DOID:2089
Cholestanol storage disease indication 63246000 DOID:4810
Disorder of biliary tract indication 105997008 DOID:9741
3-Beta-hydroxy-delta-5-C27-steroid dehydrogenase deficiency indication 238033007
Delta-4-3-oxosteroid-5-beta-reductase deficiency indication 238035000
Incomplete passage of stool indication 249515001
Calculus in biliary tract indication 266474003
Hypercholesterolemia contraindication 13644009
Obstruction of bile duct contraindication 30144000
Primary biliary cirrhosis contraindication 31712002 DOID:12236
Diarrhea contraindication 62315008
Incontinence of feces contraindication 72042002
Appendicitis contraindication 74400008 DOID:8337
Gastrointestinal obstruction contraindication 126765001
Liver function tests abnormal contraindication 166603001
Disease of liver contraindication 235856003 DOID:409
Sclerosing cholangitis contraindication 235917005 DOID:14268
Pregnancy, function contraindication 289908002
Gallstone Complications contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.92 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
250MG CHOLBAM RTRX N205750 March 17, 2015 RX CAPSULE ORAL March 17, 2020 NEW CHEMICAL ENTITY
50MG CHOLBAM RTRX N205750 March 17, 2015 RX CAPSULE ORAL March 17, 2020 NEW CHEMICAL ENTITY
250MG CHOLBAM RTRX N205750 March 17, 2015 RX CAPSULE ORAL March 17, 2022 TREATMENT OF BILE ACID SYNTHESIS DISORDERS DUE TO SINGLE ENZYME DEFECTS
50MG CHOLBAM RTRX N205750 March 17, 2015 RX CAPSULE ORAL March 17, 2022 TREATMENT OF BILE ACID SYNTHESIS DISORDERS DUE TO SINGLE ENZYME DEFECTS

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
G-protein coupled bile acid receptor 1 GPCR AGONIST EC50 5 IUPHAR

External reference:

IDSource
4034356 VUID
N0000191551 NUI
C0055568 UMLSCUI
17147002 SNOMEDCT_US
781369008 SNOMEDCT_US
007568 NDDF
1440856 RXNORM
27024 MMSL
d07574 MMSL
4034356 VANDF
CHEMBL205596 ChEMBL_ID
G1JO7801AE UNII
CHD PDB_CHEM_ID
DB02659 DRUGBANK_ID
CHEBI:16359 CHEBI
609 IUPHAR_LIGAND_ID
D019826 MESH_DESCRIPTOR_UI
221493 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cholbam HUMAN PRESCRIPTION DRUG LABEL 1 45043-001 CAPSULE 50 mg ORAL NDA 17 sections
Cholbam HUMAN PRESCRIPTION DRUG LABEL 1 45043-002 CAPSULE 250 mg ORAL NDA 17 sections