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

Stem definitionDrug idCAS RN
3068 1188-38-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • carglumic acid
  • carbaglu
  • (2S)-2-(carbamoylamino) pentanedioic acid
carglumic acid could be helpful in lowering plasma ammonia levels over 400 micromol/L more rapidly
  • Molecular weight: 190.16
  • Formula: C6H10N2O5
  • CLOGP: -1.94
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 4
  • TPSA: 129.72
  • ALOGS: -1
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.20 g O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 18, 2010 FDA ORPHAN EUROPE

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
Off label use 65.96 62.69 27 96 379814 46306125

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
Off label use 94.63 78.32 36 100 249254 29703088

Pharmacologic Action:

SourceCodeDescription
ATC A16AA05 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Amino acids and derivatives
FDA MoA N0000184143 Carbamoyl Phosphate Synthetase 1 Activators
FDA EPC N0000184144 Carbamoyl Phosphate Synthetase 1 Activator
CHEBI has role CHEBI:71031 orphan drugs
CHEBI has role CHEBI:71033 carbamylphosphate synthetase i activators

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hyperammonemia associated with N-acetylglutamate synthase deficiency indication
Breastfeeding (mother) contraindication 413712001

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.57 acidic
pKa2 5.14 acidic
pKa3 12.49 acidic
pKa4 13.51 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
200MG CARBAGLU RECORDATI RARE N022562 March 18, 2010 RX TABLET, FOR SUSPENSION ORAL Jan. 22, 2028 IN PEDIATRIC AND ADULT PATIENTS AS ADJUNCTIVE THERAPY TO STANDARD OF CARE FOR THE TREATMENT OF ACUTE HYPERAMMONEMIA DUE TO PROPIONIC ACIDEMIA (PA) OR METHYLMALONIC ACIDEMIA (MMA)

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Carbamoyl-phosphate synthase [ammonia], mitochondrial Enzyme POSITIVE ALLOSTERIC MODULATOR CHEMBL CHEMBL

External reference:

IDSource
4030904 VUID
N0000182969 NUI
D07130 KEGG_DRUG
4030904 VANDF
C2353303 UMLSCUI
CHEBI:71028 CHEBI
CHEMBL1201780 ChEMBL_ID
DB06775 DRUGBANK_ID
8008 INN_ID
C528449 MESH_SUPPLEMENTAL_RECORD_UI
121396 PUBCHEM_CID
7458 IUPHAR_LIGAND_ID
5L0HB4V1EW UNII
401713 RXNORM
20611 MMSL
72491 MMSL
d05656 MMSL
004390 NDDF
408045002 SNOMEDCT_US
412295009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Carbaglu HUMAN PRESCRIPTION DRUG LABEL 1 52276-312 TABLET 200 mg ORAL NDA 25 sections