NDAINJECTIONINJECTABLE
Approved
Jan 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
2/8 — Basic
Drug data last refreshed 15h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NOVAMINE 11.4% is an injectable amino acid formulation approved in 1978 by Pfizer for nutritional support and metabolic enhancement. It is indicated for muscle atrophy, pressure ulcers, muscle loss, chronic kidney disease, traumatic brain injury, and multiple oncologic and degenerative conditions. The product works as a parenteral amino acid source to support protein synthesis and tissue repair.
LOE Approaching
Product approaching loss of exclusivity with minimal competitive pressure (30/100), signaling potential downsizing or transition planning for brand team.
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 (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.