NDAINJECTIONINJECTABLE
Approved
Apr 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
17
Data completeness
2/8 — Basic
Drug data last refreshed 23h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMINOSYN II 3.5% is an intravenous amino acid injection used to provide nutritional support in patients unable to meet protein requirements through oral intake. It supplies essential and non-essential amino acids for protein synthesis and metabolic function. This product is a nutritional therapy component typically used in hospital and critical care settings.
LOE Approaching
As a legacy injectable nutrition product approaching loss of exclusivity, the brand team is likely in transition or maintenance mode with minimal growth investment.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (17)
Nutritional Status in Patients With Chronic Kidney Disease Receiving 7.2% Amino Acids During Hemodialysis
Started Jul 2026
90 enrolled
MalnutitrionChronic Kidney Disease on HemodialysisAnemia (Diagnosis)
The Effects of a Dialysis-Specific Formula Rich in Branched-Chain Amino Acids, Omega-3, and Dietary Fiber on Nutritional Status
Started Jul 2025
100 enrolled
ESRD (End-Stage Renal Disease)Dialysis
Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
Started Jun 2024
31 enrolled
Hepatic SteatosisNAFLDAdolescent Obesity
The Glucagonotropic Effect of Amino Acids in Humans
Started Sep 2023
12 enrolled
Healthy
Additional Dietary Large Neutral Amino Acids (LNAA) for Improved Symptoms in Adult Classical Phenylktonuria (PKU)
Started Sep 2023
10 enrolled
Phenylketonurias
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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.