NDAORALTABLET, FOR SUSPENSIONPriority Review
Approved
Mar 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
6/8 — Strong
Priority Review
CARBAGLU (carglumic acid) by Recordati is carbamoyl phosphate synthetase 1 activators [moa]. Approved for hyperammonemia. First approved in 2010.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CARBAGLU (carglumic acid) is an oral tablet suspension formulation approved in March 2010 that functions as a carbamoyl phosphate synthetase 1 (CPS1) activator. It is indicated for the treatment of hyperammonemia by enhancing the urea cycle, a critical metabolic pathway for nitrogen disposal. The drug works by activating CPS1, the rate-limiting enzyme in the urea cycle, thereby facilitating ammonia detoxification. It represents a specialized pharmaceutical intervention for rare metabolic disorders affecting ammonia metabolism.
$0.0BPart D
1.7 years to LOEMechanism of Action
Carbamoyl Phosphate Synthetase 1 Activators
Pharmacologic Class:
Carbamoyl Phosphate Synthetase 1 Activator
Indications (1)
Clinical Trials (3)
An Observational Study of Carbaglu® for the Treatment of MMA and PA in Adults and Pediatrics
Started Jun 2022
20 enrolled
HyperammonemiaMethylmalonic AcidemiaPropionic Acidemia
Understanding the Long-Term Management of Organic Acidemia Patients With CARBAGLU®: A Mixed Methods Approach
Started Jan 2019
95 enrolled
Methylmalonic AcidemiaPropionic Acidemia
N-Carbamylglutamate (Carbaglu) In The Treatment Of Hyperammonemia
Started Aug 2008
52 enrolled
Inborn Errors of Metabolism
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.