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 3h ago · AI intelligence enriched 1mo 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 works by enabling conjugation with glutamine and glycine to form phenylacetylglutamine and hippuric acid, respectively, which are then renally excreted as waste nitrogen alternatives to urea. This mechanism bypasses defects in any of the six urea cycle enzymes (NAGS, CPS, ASS, OTC, ASL, ARG).
LOE Approaching
As an aging IV therapy approaching loss of exclusivity with moderate competitive pressure (30/100), brand teams face declining revenue and shrinking portfolios, signaling potential restructuring or transition opportunities.
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.