NDAINJECTIONINJECTABLE
Approved
Dec 1975
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
3/8 — Basic
AMINOSYN 7% (amino acids) by ICU Medical. Approved for muscle atrophy, pressure ulcers. First approved in 1975.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMINOSYN 7% is an injectable amino acid solution indicated for muscle atrophy and pressure ulcer management, typically administered as part of parenteral nutrition support in hospitalized or critically ill patients. It provides essential and non-essential amino acids to support protein synthesis and metabolic recovery. The product works by supplying exogenous amino acids to meet elevated protein demands in catabolic states.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30), signaling potential team downsizing or transition to generics-focused operational roles.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (2)
Clinical Trials (16)
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
55 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
Bioavailability of Plant Protein Amino Acids
Started Jan 2020
10 enrolled
Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men
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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.