ENDARI (l-glutamine)
Endari (L-glutamine) is an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older. By addressing the underlying oxidative stress in sickle red blood cells, it helps manage the frequency of crises associated with the condition.
How ENDARI Works
The exact mechanism of action of L-glutamine in treating sickle cell disease is not fully understood. It is proposed to address oxidative stress, which makes sickle red blood cells more susceptible to damage and contributes to hemolysis and vaso-occlusive events. L-glutamine may improve the NAD redox potential in sickle red blood cells by increasing the availability of reduced glutathione, which helps regulate and prevent oxidative damage.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-07-07
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
ENDARI Approval History
What ENDARI Treats
1 indicationsENDARI is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Sickle Cell Disease
ENDARI 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.
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Clinical Trial Registry
23 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06617182 | KY20242229-F-1 | Ph 2 | recruiting | Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury. |
| NCT05655819 | 22-004343 | Ph 1, Ph 2 | completed | A Study of Glutamine to Treat Intestinal Permeability in Functional Dyspepsia |
| 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 |
| NCT01952847 results posted | 2013-0308 NCI-2014-00917 | Ph 3 | terminated | Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis |
| NCT04388371 | 190481 | Ph 1 | completed | Glutamine PET Imaging in LAM |
| 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 |
| NCT01983969 results posted | 2013-0186 NCI-2014-01025 | Ph 1, Ph 2 | completed | Aza-SAHA-GBM With AutoSCT for Refractory Lymphoma |
| NCT02589145 results posted | 2015-0558 NCI-2015-01938 | Ph 1, Ph 2 | terminated | Lenalidomide Combined With Vorinostat/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Diffuse Large B-Cell Lymphoma of the ABC Subtype |
| NCT01783522 results posted | CASE2A10 NCI-2011-01866 | Ph 2 | terminated | Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib |
| NCT02012608 results posted | 202253 | Ph 2 | terminated | Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy |
| NCT01414244 AT005291 results posted | 11-271 | Ph 2 | completed | Glutamine for the Treatment of Patients With Irritable Bowel Syndrome |
| NCT02961816 | 2016-0074 NCI-2016-01914 | Ph 2 | withdrawn | Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Lymphoma |
| NCT02701673 | 2015-0560 | Ph 1, Ph 2 | withdrawn | Belinostat Combined With Azacitidine/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Refractory or Relapsed Lymphoma |
| NCT00645879 | 24806 1R21DK077415-01A1, ANA-PA-001 | Ph 1 | completed | Anaplerotic Therapy in Propionic Acidemia |
| NCT02114502 | 2013-0892 | Ph 2 | withdrawn | Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma |
| NCT01794884 | glncardio001 | Ph 2 | completed | Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery |
| NCT01263041 preterm | ghada a. saleh MD protocol | Ph 2, Ph 3 | completed | Effect of L-arginine and Glutamine on Preterm |
| NCT01087658 GLUTOX | OXALI_L_03768 U1111-1116-9494 | Ph 3 | completed | Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity |
| NCT00913692 results posted | 090159 09-I-0159 | Ph 2 | terminated | A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis |
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.
ENDARI FDA Label Details
Indications & Usage
FDA Label (PDF)ENDARI is indicated for the treatment of Sickle Cell Disease.
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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