L-GLUTAMINE
L-glutamine is an amino acid used to reduce the acute complications associated with sickle cell disease. It helps patients five years of age and older, including both children and adults. This treatment is prescribed to help manage the chronic hemolysis and vaso-occlusive events that often occur in those with the condition.
How L-GLUTAMINE Works
This amino acid works by increasing the availability of reduced glutathione, which improves the NAD redox potential within sickle red blood cells. By regulating oxidative stress, it helps protect these cells from the damage that leads to cell breakdown and vessel blockages.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-07-08
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
L-GLUTAMINE Approval History
What L-GLUTAMINE Treats
1 indicationsL-GLUTAMINE is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Sickle Cell Disease
L-GLUTAMINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to L-GLUTAMINE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07210450 | IR.MAZUMS.REC.1402.246 | Ph 2, Ph 3 | completed | Effect of L-Glutamine on Pulmonary Artery Pressure in Patients With Non-Transfusion-Dependent Thalassemia |
| NCT04634539 | IIT2020-02-Gong-GLUTAPANC | Ph 1 | completed | Trial of First-line L-glutamine With Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer |
| NCT05106101 | EM-DsD-002 | Ph 1 | completed | L-glutamine Treatment in Patients With Diverticulosis |
| NCT04684381 | EM-PK-01 | Ph 4 | completed | Pharmacokinetics and Safety of Endari (L-glutamine) in Sickle Cell Disease Patients |
| NCT01048905 results posted | 1R01FD003531-01 IRB 2008-059, 1R01FD003531-01 | Ph 2 | completed | Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension |
| NCT01179217 results posted | GLUSCC09-01 | Ph 3 | completed | A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
L-GLUTAMINE FDA Label Details
Indications & Usage
L-GLUTAMINE is indicated for the treatment of Sickle Cell Disease.
Looking for the branded version?
ENDARI
Full clinical data, patents, trials, and competitive landscape for l-glutamine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment