NDAINJECTIONINJECTABLE
Approved
Feb 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
2/8 — Basic
Drug data last refreshed 6h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEPHRAMINE 5.4% is an injectable amino acid formulation designed for patients with significant muscle loss, atrophy, and metabolic complications associated with chronic kidney disease and critical illness. The product provides essential and non-essential amino acids tailored to renal insufficiency, supporting protein synthesis while minimizing uremic waste accumulation. It is indicated across a broad spectrum of catabolic conditions including CKD Stage 4, traumatic brain injury, pressure ulcers, and select malignancies.
LOE Approaching
Product is in late lifecycle with moderate competitive pressure (30), signaling smaller brand teams focused on margin defense and specialty hospital channels rather than growth.
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.