carglumic acid 🐶 Veterinary Use | 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:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 21 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 18, 2010 | FDA | ORPHAN EUROPE |
FDA Adverse Event Reporting System (Female)
None
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 | 85.95 | 81.10 | 38 | 107 | 419486 | 34537300 |
FDA Adverse Event Reporting System (Geriatric)
| 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 | 115.36 | 64.18 | 53 | 176 | 907162 | 78836997 |
| Ammonia increased | 103.54 | 64.18 | 18 | 211 | 7617 | 79736542 |
FDA Adverse Event Reporting System (Pediatric)
None
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 | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hyperammonemia associated with N-acetylglutamate synthase deficiency | indication | ||
| Breastfeeding (mother) | contraindication | 413712001 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
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 |
| C1318649 | UMLSCUI |
| CHEBI:71028 | CHEBI |
| CHEMBL1201780 | ChEMBL_ID |
| DB06775 | DRUGBANK_ID |
| 121396 | PUBCHEM_CID |
| 8008 | INN_ID |
| C528449 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7458 | IUPHAR_LIGAND_ID |
| 5L0HB4V1EW | UNII |
| 401713 | RXNORM |
| 20611 | MMSL |
| 302324 | MMSL |
| 72491 | MMSL |
| d05656 | MMSL |
| 004390 | NDDF |
| 408045002 | SNOMEDCT_US |
| 412295009 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Carglumic acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 35573-459 | TABLET, FOR SUSPENSION | 200 mg | ORAL | ANDA | 22 sections |
| Carbaglu | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52276-312 | TABLET, FOR SUSPENSION | 200 mg | ORAL | NDA | 26 sections |
| Carbaglu | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52276-312 | TABLET, FOR SUSPENSION | 200 mg | ORAL | NDA | 26 sections |
| Carglumic acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68475-006 | TABLET, FOR SUSPENSION | 200 mg | ORAL | ANDA | 22 sections |
| Carglumic acid | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68475-006 | TABLET, FOR SUSPENSION | 200 mg | ORAL | ANDA | 22 sections |
| Carglumic Acid | Human Prescription Drug Label | 1 | 71863-114 | TABLET, FOR SUSPENSION | 200 mg | ORAL | ANDA | 25 sections |
| Carglumic Acid | Human Prescription Drug Label | 1 | 71863-114 | TABLET, FOR SUSPENSION | 200 mg | ORAL | ANDA | 25 sections |