NDAORALFOR SOLUTION
Approved
Jun 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
NUTRESTORE (l-glutamine) by Emmaus Life Sciences is l-glutamine in treating sickle cell disease (scd) is not fully understood. First approved in 2004.
Drug data last refreshed 3m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUTRESTORE is an oral L-glutamine solution approved for sickle cell disease (SCD) that works by improving NAD redox potential in sickle red blood cells through increased availability of reduced glutathione, thereby reducing oxidative stress and hemolysis. The mechanism addresses the fundamental pathophysiology of SCD by protecting sickle RBCs from oxidative damage that contributes to chronic hemolysis and vaso-occlusive events.
LOE Approaching
Product is approaching loss of exclusivity with minimal competitive pressure (30), suggesting commercial teams should prioritize market defense and lifecycle management initiatives.
Mechanism of Action
L-glutamine in treating sickle cell disease (SCD) is not fully understood. Oxidative stress phenomena are involved in the pathophysiology of SCD. Sickle red blood cells (RBCs) are more susceptible to oxidative damage than normal RBCs, which may contribute to the chronic hemolysis and vaso-occlusive…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
A Clinical Study of Alanyl-Glutamine for Reduction of Post-Myomectomy Adhesions
Started Feb 2015
47 enrolled
Pelvic Adhesions
Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition
Started Aug 2004
108 enrolled
Diarrhea, Malnutrition
L-Glutamine Therapy for Sickle Cell Anemia
Started Feb 2004
15 enrolled
Sickle Cell AnemiaThalassemia
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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.