NDAORALFOR SOLUTION
Approved
Jul 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
17
Data completeness
5/8 — Partial
ENDARI (glutamine) by Emmaus Life Sciences is l-glutamine in treating sickle cell disease (scd) is not fully understood. First approved in 2017.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENDARI (L-glutamine) is an oral amino acid therapeutic approved for sickle cell disease (SCD) in 2017. It works by improving NAD redox potential in sickle red blood cells, reducing oxidative stress and theoretically decreasing hemolysis and vaso-occlusive events. The mechanism of action remains incompletely understood but targets the underlying pathophysiology of SCD rather than symptomatic relief alone.
$8MPart D
PeakENDARI is in peak commercial phase with modest Part D spending ($8M) and limited claim volume (2,325 in 2023), suggesting a niche product with stable but constrained market penetration.
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…
Pharmacologic Class:
Amino Acid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (17)
Stemchymal® for Polyglutamine Spinocerebellar Ataxia
Started Jun 2025
20 enrolled
Spinocerebellar Ataxias
Glutamine Supplementation in People With Immune Dysregulation
Started Mar 2020
0EczemaMTOROC1 Signaling
Reduction of Occurence of Acute Kidney Injury (AKI) Through Administration of Glutamine
Started Jul 2019
64 enrolled
Cardiac SurgeryAcute Kidney Injury
4-[18F]Fluoroglutamine PET/CT in Imaging Patients With Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules
Started Jun 2017
30 enrolled
Lung CancerSolitary Pulmonary NoduleCigarette Smoking Behavior
Efficacy and Safety Study of Stemchymal® in Polyglutamine Spinocerebellar Ataxia
Started Sep 2015
56 enrolled
Cerebellar Ataxia
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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.