Stem definition | Drug id | CAS RN |
---|---|---|
3068 | 1188-38-1 |
Dose | Unit | Route |
---|---|---|
0.20 | g | O |
None
Date | Agency | Company | Orphan |
---|---|---|---|
March 18, 2010 | FDA | ORPHAN EUROPE |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Off label use | 65.96 | 62.69 | 27 | 96 | 379814 | 46306125 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Off label use | 94.63 | 78.32 | 36 | 100 | 249254 | 29703088 |
Source | Code | Description |
---|---|---|
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 |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Hyperammonemia associated with N-acetylglutamate synthase deficiency | indication | ||
Breastfeeding (mother) | contraindication | 413712001 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 3.57 | acidic |
pKa2 | 5.14 | acidic |
pKa3 | 12.49 | acidic |
pKa4 | 13.51 | acidic |
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
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) |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Carbamoyl-phosphate synthase [ammonia], mitochondrial | Enzyme | POSITIVE ALLOSTERIC MODULATOR | CHEMBL | CHEMBL |
ID | Source |
---|---|
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 |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Carbaglu | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52276-312 | TABLET | 200 mg | ORAL | NDA | 25 sections |