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Carbaglu(carglumic acid)
Carbaglu (carglumic acid) is a small molecule pharmaceutical. Carglumic acid was first approved as Carbaglu on 2003-01-24. It is used to treat hyperammonemia in the USA. It has been approved in Europe to treat hyperammonemia, inborn errors amino acid metabolism, and propionic acidemia.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Carbaglu (generic drugs available since 2021-10-13)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Carglumic acid
Tradename
Company
Number
Date
Products
CARBAGLURecordatiN-022562 RX2010-03-18
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
carbagluNew Drug Application2021-01-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hyperammonemiaHP_0001987D022124E72.20
Agency Specific
FDA
EMA
Expiration
Code
CARGLUMIC ACID, CARBAGLU, RECORDATI RARE
2028-01-22ODE-345
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AA: Amino acids and derivatives
— A16AA05: Carglumic acid
HCPCS
No data
Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Propionic acidemiaD056693E71.121—11—35
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ornithine carbamoyltransferase deficiency diseaseD020163EFO_0007409E72.4—1———1
Carbamoyl-phosphate synthase i deficiency diseaseD020165EFO_0007193—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperammonemiaD022124HP_0001987E72.20————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCARGLUMIC ACID
INNcarglumic acid
Description
Carglumic acid is a urea that is the N-carbamoyl derivative of L-glutamic acid. An orphan drug used to treat a deficiency in the enzyme N-acetylglutamate synthase, which leads to acute hyperammonaemia. It has a role as an orphan drug and a carbamylphosphate synthetase I activator. It is a N-acyl-L-glutamic acid and a member of ureas.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
NC(=O)N[C@@H](CCC(=O)O)C(=O)O
Identifiers
PDB—
CAS-ID1188-38-1
RxCUI401713
ChEMBL IDCHEMBL1201780
ChEBI ID71028
PubChem CID121396
DrugBankDB06775
UNII ID5L0HB4V1EW (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 249 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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41,011 adverse events reported
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