Carglumic acid

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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 is an orphan drug, marketed by Orphan Europe under the trade name Carbaglu. Carglumic acid is used for the treatment of hyperammonaemia in patients with N-acetylglutamate synthase deficiency.[1][2] The initial daily dose ranges from 100 to 250 mg/kg, adjusted thereafter to maintain normal plasma levels of ammonia.

The US FDA approved it for treatment of hyperammonaemia on March 18, 2010. Orphan Drug exclusivity expired on March 18, 2017.[3]

Adverse effects

The most common adverse effects include vomiting, abdominal pain, fever, and tonsillitis.[4]

References

  1. ^ 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.
  2. ^ 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.
  3. ^ "Patent and Exclusivity Search Results".
  4. ^ Drugs.com: Professional Drug Facts for Carglumic Acid.
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