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

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: -1.40
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:

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	P31327	CPSM_HUMAN	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