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Chemical compound
Carglumic acid
Trade names Carbaglu, Ucedane Other names (S )-2-ureidopentanedioic acid
AHFS /
Drugs.com
Monograph
License data
Pregnancy category
Routes of administration
By mouth
ATC code
Legal status
Bioavailability 30%
Protein binding Undetermined
Metabolism Partial
Elimination half-life 4.3 to 9.5 hours
Excretion Fecal (60%) and
kidney (9%, unchanged)
(2S )-2-(carbamoylamino)pentanedioic acid
CAS Number
PubChem
CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (
EPA )
ECHA InfoCard
100.116.323
Formula C 6 H 10 N 2 O 5
Molar mass 190.155 g·mol−1 3D model (
JSmol )
C(CC(=O)O)[C@@H](C(=O)O)NC(=O)N
InChI=1S/C6H10N2O5/c7-6(13)8-3(5(11)12)1-2-4(9)10/h3H,1-2H2,(H,9,10)(H,11,12)(H3,7,8,13)/t3-/m0/s1
Y Key:LCQLHJZYVOQKHU-VKHMYHEASA-N
Y
N Y
(what is this?)
(verify)
Carglumic acid , sold under the brand name Carbaglu among others, is used for the treatment of
hyperammonaemia .
[3]
[6]
[7] Carglumic acid is a
carbamoyl phosphate synthetase 1 (CPS 1) activator.
[3]
The most common adverse effects include vomiting, abdominal pain,
pyrexia (fever), and
tonsillitis ,
anemia , diarrhea, ear infection, other infections,
nasopharyngitis , decreased
hemoglobin levels, and headache.
[3]
It was approved for medical use in the United States in March 2010.
[8] Carglumic acid is an
orphan drug .
[9]
[10] It is available as a
generic medication .
[11]
Medical uses
Carglumic acid is
indicated for the treatment of acute hyperammonemia and chronic hyperammonemia.
[3]
[4]
[5]
References
^
"Prescription medicines: registration of new chemical entities in Australia, 2015" . Therapeutic Goods Administration (TGA) . 21 June 2022. Retrieved 10 April 2023 .
^
"Health Canada New Drug Authorizations: 2015 Highlights" .
Health Canada . 4 May 2016. Retrieved 7 April 2024 .
^
a
b
c
d
e
"Carbaglu- carglumic acid tablet" . DailyMed . Retrieved 9 June 2021 .
^
a
b
"Carbaglu EPAR" .
European Medicines Agency (EMA) . 17 September 2018. Retrieved 9 June 2021 .
^
a
b
"Ucedane EPAR" .
European Medicines Agency (EMA) . 17 September 2018. Retrieved 9 June 2021 .
^ Caldovic L, Morizono H, Daikhin Y, Nissim I, McCarter RJ, Yudkoff M, Tuchman M (2004). "Restoration of ureagenesis in N-acetylglutamate synthase deficiency by N-carbamylglutamate". J Pediatr . 145 (4): 552–4.
doi :
10.1016/j.jpeds.2004.06.047 .
PMID
15480384 .
^ Elpeleg O, Shaag A, Ben-Shalom E, Schmid T, Bachmann C (2002).
"N-acetylglutamate synthase deficiency and the treatment of hyperammonemic encephalopathy" . Ann Neurol . 52 (6): 845–9.
doi :
10.1002/ana.10406 .
PMID
12447942 .
S2CID
24604774 .
^
"Drug Approval Package: Carbaglu (Carglumic Acid) Tablets" . U.S.
Food and Drug Administration (FDA) . 16 February 2010. Retrieved 9 June 2021 .
^
"Carglumic acid Orphan Drug Designations and Approvals" . U.S.
Food and Drug Administration (FDA) . 17 June 2014. Retrieved 9 June 2021 .
^
"Carglumic acid Orphan Drug Designations and Approvals" . U.S.
Food and Drug Administration (FDA) . 20 January 1998. Retrieved 9 June 2021 .
^
"Competitive Generic Therapy Approvals" . U.S.
Food and Drug Administration (FDA) . 29 June 2023.
Archived from the original on 29 June 2023. Retrieved 29 June 2023 .