Carglumic acid

Carglumic acid
Clinical data
Trade namesCarbaglu, Ucedane
Other names(S)-2-ureidopentanedioic acid
AHFS/Drugs.comMonograph
License data
Pregnancy
category
  • AU: B1
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability30%
Protein bindingUndetermined
MetabolismPartial
Elimination half-life4.3 to 9.5 hours
ExcretionFecal (60%) and kidney (9%, unchanged)
Identifiers
  • (2S)-2-(carbamoylamino)pentanedioic acid
CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.116.323 Edit this at Wikidata
Chemical and physical data
FormulaC6H10N2O5
Molar mass190.155 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 checkY
  • Key:LCQLHJZYVOQKHU-VKHMYHEASA-N checkY
 ☒NcheckY (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

  1. ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  2. ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Retrieved 7 April 2024.
  3. ^ a b c d e "Carbaglu- carglumic acid tablet". DailyMed. Retrieved 9 June 2021.
  4. ^ a b "Carbaglu EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 9 June 2021.
  5. ^ a b "Ucedane EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 9 June 2021.
  6. ^ 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.
  7. ^ 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.
  8. ^ "Drug Approval Package: Carbaglu (Carglumic Acid) Tablets". U.S. Food and Drug Administration (FDA). 16 February 2010. Retrieved 9 June 2021.
  9. ^ "Carglumic acid Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 17 June 2014. Retrieved 9 June 2021.
  10. ^ "Carglumic acid Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 20 January 1998. Retrieved 9 June 2021.
  11. ^ "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.


Stub icon

This drug article relating to the gastrointestinal system is a stub. You can help Wikipedia by expanding it.