AMMONUL
LOE ApproachingNDAINTRAVENOUSSOLUTIONPriority Review
Approved
Feb 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
Priority Review
AMMONUL by Bausch + Lomb is enzymes: n -acetylglutamate synthetase (nags), carbamyl phosphate synthetase (cps), argininosuccinate synthetase (ass), ornithine transcarbamylase (otc), argininosuccinate lyase (asl), or arginase (arg). First approved in 2005.
Drug data last refreshed 2h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMMONUL is an intravenous solution containing sodium phenylacetate and sodium benzoate that provides an alternative nitrogen disposal pathway for patients with urea cycle disorders. It bypasses defective urea cycle enzymes by conjugating phenylacetate with glutamine and benzoate with glycine, enabling renal excretion of waste nitrogen. This mechanism allows patients with genetic defects in any of six urea cycle enzymes (NAGS, CPS, ASS, OTC, ASL, ARG) to safely manage hyperammonemia.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), indicating a contracting commercial opportunity and potential team downsizing.
Mechanism of Action
enzymes: N -acetylglutamate synthetase (NAGS), carbamyl phosphate synthetase (CPS), argininosuccinate synthetase (ASS), ornithine transcarbamylase (OTC), argininosuccinate lyase (ASL), or arginase (ARG). Sodium phenylacetate and sodium benzoate are metabolically active compounds that can serve as…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy
Started Dec 2007
1 enrolled
Hepatic Encephalopathy
Worked on AMMONUL at Bausch + Lomb? Share your interview experience or compensation data (+7 days Pro)
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.