carglumic acid Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 3068 | 1188-38-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
carglumic acid could be helpful in lowering plasma ammonia levels over 400 micromol/L more rapidly
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.20 | g | O |
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 18, 2010 | FDA | ORPHAN EUROPE |
FDA Adverse Event Reporting System (Female)
| 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 |
FDA Adverse Event Reporting System (Male)
| 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 |
Pharmacologic Action:
| 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 |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hyperammonemia associated with N-acetylglutamate synthase deficiency | indication | ||
| Breastfeeding (mother) | contraindication | 413712001 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (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 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) |
Bioactivity Summary:
| 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 |
External reference:
| 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 |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Carbaglu | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52276-312 | TABLET | 200 mg | ORAL | NDA | 25 sections |