Carglumic acid explained

Verifiedfields:changed
Verifiedrevid:460019355
Tradename:Carbaglu, Ucedane
Dailymedid:Carglumic acid
Pregnancy Au:B1
Routes Of Administration:By mouth
Atc Prefix:A16
Atc Suffix:AA05
Legal Au:S4
Legal Au Comment:[1]
Legal Ca:Rx-only
Legal Ca Comment:[2]
Legal Us:Rx-only
Legal Us Comment:[3]
Legal Eu:Rx-only
Legal Eu Comment:[4] [5]
Bioavailability:30%
Protein Bound:Undetermined
Metabolism:Partial
Elimination Half-Life:4.3 to 9.5 hours
Excretion:Fecal (60%) and kidney (9%, unchanged)
Cas Number:1188-38-1
Pubchem:121396
Iuphar Ligand:7458
Drugbank:DB06775
Chemspiderid:1265942
Chemspiderid2:108351
Unii:5L0HB4V1EW
Kegg:D07130
Chebi:71028
Chembl:1201780
Synonyms:(S)-2-ureidopentanedioic acid
Iupac Name:(2S)-2-(carbamoylamino)pentanedioic acid
C:6
H:10
N:2
O:5
Smiles:C(CC(=O)O)[C@@H](C(=O)O)NC(=O)N
Stdinchi: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
Stdinchikey:LCQLHJZYVOQKHU-VKHMYHEASA-N

Carglumic acid, sold under the brand name Carbaglu among others, is used for the treatment of hyperammonaemia.[6] [7] Carglumic acid is a carbamoyl phosphate synthetase 1 (CPS 1) activator.

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.

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.

Notes and References

  1. Web site: Prescription medicines: registration of new chemical entities in Australia, 2015 . Therapeutic Goods Administration (TGA) . 21 June 2022 . 10 April 2023.
  2. Web site: Health Canada New Drug Authorizations: 2015 Highlights . . 4 May 2016 . 7 April 2024.
  3. Web site: Carbaglu- carglumic acid tablet . DailyMed . 9 June 2021.
  4. Web site: Carbaglu EPAR . European Medicines Agency (EMA) . 17 September 2018 . 9 June 2021.
  5. Web site: Ucedane EPAR . European Medicines Agency (EMA) . 17 September 2018 . 9 June 2021.
  6. Caldovic L, Morizono H, Daikhin Y, Nissim I, McCarter RJ, Yudkoff M, Tuchman M . Restoration of ureagenesis in N-acetylglutamate synthase deficiency by N-carbamylglutamate . J Pediatr . 145 . 4 . 552–4 . 2004 . 15480384 . 10.1016/j.jpeds.2004.06.047.
  7. Elpeleg O, Shaag A, Ben-Shalom E, Schmid T, Bachmann C . N-acetylglutamate synthase deficiency and the treatment of hyperammonemic encephalopathy . Ann Neurol . 52 . 6 . 845–9 . 2002 . 12447942 . 10.1002/ana.10406. 24604774 . free .
  8. Web site: Drug Approval Package: Carbaglu (Carglumic Acid) Tablets . U.S. Food and Drug Administration (FDA) . 16 February 2010 . 9 June 2021.
  9. Web site: Carglumic acid Orphan Drug Designations and Approvals . U.S. Food and Drug Administration (FDA) . 17 June 2014 . 9 June 2021.
  10. Web site: Carglumic acid Orphan Drug Designations and Approvals . U.S. Food and Drug Administration (FDA) . 20 January 1998 . 9 June 2021.
  11. Web site: Competitive Generic Therapy Approvals . U.S. Food and Drug Administration (FDA) . 29 June 2023 . 29 June 2023 . 29 June 2023 . https://web.archive.org/web/20230629233651/https://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals . live .

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