glutamine

ApprovedSmall molecule

Sanofi

glutamine is one of 187 small molecule programs targeting Sickle Cell Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

186

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Sickle Cell DiseaseUnknown

BurnActive, not recruiting

Primary Short Bowel SyndromeUnknown

Short Bowel SyndromeUnknown

Gastric CancerActive, not recruiting

EnteritisActive, not recruiting

Oral MucositisActive, not recruiting

PneumoniaUnknown status

Sickle Cell DiseasePreclinical

Unknown

BurnPreclinical

Active, not recruiting

Primary Short Bowel SyndromePreclinical

Unknown

Short Bowel SyndromePreclinical

Unknown

Gastric CancerPreclinical

Active, not recruiting

EnteritisPreclinical

Active, not recruiting

Oral MucositisPreclinical

Active, not recruiting

PneumoniaApproved

Unknown status

Competition

Competitive Landscape

193 competitors in Gastric Cancer

#DrugCompanyPhaseTrials

Opdivo

Bristol-Myers Squibb

Phase 3

24 2

Keytruda

Merck & Co.

Phase 3

19 3

Xeloda

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

91 4

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

55 5

Taxotere

AAvyxa

Phase 3

45 6

Avastin

Roche

Phase 3

11 7

Abraxane

Bristol-Myers Squibb

Phase 3

11 8

Tyvyt

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

20 9

Wellcovorin

GGlaxo Dba Glaxosmithkline

Phase 3

19 10

Tuoyi

SSun Yat-sen University

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Not yet recruiting

Injury

NCT06617182

Q2 2027

Phase 3Not yet recruiting

Neuropathy

NCT07287592

Clinical

Trials by Indication[1]

Lymphoma3 trials

Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Lymphoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT02961816

Aza-SAHA-GBM With AutoSCT for Refractory Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01983969·61 enrolled

Belinostat Combined With Azacitidine/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Refractory or Relapsed Lymphoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 1/2·NCT02701673

Duchenne Muscular Dystrophy2 trials

Creatine and Glutamine in Steroid-Naive Duchenne Muscular Dystrophy

Completed·CCooperative International Neuromuscular Research Group·Phase 2/3·NCT00016653·48 enrolled

A Multicenter Randomized Placebo-Controlled Double-Blind Study to Assess Efficacy and Safety of Glutamine and Creatine Monohydrate in Duchenne Muscular Dystrophy (DMD)

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00018109

Trauma2 trials

Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy

Completed·UUniversity of Missouri, Kansas City·N/A·NCT01239680·5 enrolled

Enteral Glutamine Supplementation for the Patient With Major Torso Trauma

Terminated·TThe University of Texas Health Science Center, Houston·Phase 1·NCT00178581·20 enrolled

Diarrhea2 trials

Long-term Impact and Intervention for Diarrhea in Brazil

Unknown status·UUniversity of Virginia·Phase 3·NCT00133406·321 enrolled

Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

Completed·AAHS Cancer Control Alberta·Phase 2·NCT00255229·130 enrolled

Peripheral Neuropathy2 trials

Randomized Placebo-Controlled Trial of Glutamine for Breast Cancer Patients With Peripheral Neuropathy

Completed·WWeill Medical College of Cornell University·Phase 3·NCT00195013·30 enrolled

Glutamine in Preventing Peripheral Neuropathy in Patients With Multiple Myeloma Receiving Bortezomib

Terminated·BBeth Faiman·Phase 2·NCT01783522·9 enrolled

33 more indications

Neuropathy2 trials

Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer.

Not yet recruiting·—·Phase 3·NCT07287592·70 enrolled

Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors

Completed·—·Phase 2·NCT00365768·56 enrolled

Herpes Labialis1 trial

A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00913692·11 enrolled

Neurotoxicity1 trial

Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity

Completed· Sanofi logo

Sanofi·Phase 3·NCT01087658·200 enrolled

Bone Marrow Transplant1 trial

Effects on Glutamine on the Outcome of Allogeneic Bone Marrow Transplant Recipients

Unknown status·HHospital Authority, Hong Kong·N/A·NCT00563498·40 enrolled

Propionic Acidemia1 trial

Anaplerotic Therapy in Propionic Acidemia

Completed·NNicola Longo·Phase 1·NCT00645879·3 enrolled

Imaging1 trial

Glutamine PET Imaging in LAM

Completed·VVanderbilt University Medical Center·Phase 1·NCT04388371·5 enrolled

Side Effects1 trial

Efficacy of an Oral Formula in Prevention of Anti-cancer Therapy Side Effects

Completed·SSociété des Produits Nestlé (SPN)·Phase 3·NCT00455247

Short Bowel Syndrome1 trial

Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

Completed·—·N/A·NCT01576003·10 enrolled

Stem Cell Transplant1 trial

Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT02114502

Intensive Care Unit1 trial

Scandinavian Intensive Care Unit (ICU) Glutamine Study

Terminated·SScandinavian Critical Care Trials Group·Phase 4·NCT00922714·1,000 enrolled

Low Birth Weight1 trial

Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion

Unknown status·NNational Center for Research Resources (NCRR)·N/A·NCT00005889·96 enrolled

Dyspepsia1 trial

A Study of Glutamine to Treat Intestinal Permeability in Functional Dyspepsia

Completed·—·Phase 1/2·NCT05655819·12 enrolled

Pre-Term1 trial

Effect of L-arginine and Glutamine on Preterm

Completed·—·Phase 2/3·NCT01263041·75 enrolled

Effectiveness1 trial

Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.

Unknown status·HHospital Universitari Son Dureta·Phase 2·NCT01250782·150 enrolled

Toxicity1 trial

Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

Terminated·UUniversity of Arkansas·Phase 2·NCT02012608·14 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Lenalidomide Combined With Vorinostat/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Diffuse Large B-Cell Lymphoma of the ABC Subtype

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT02589145·8 enrolled

Metabolism1 trial

Glutamine and Intestinal Protein Metabolism

Completed·UUniversity Hospital, Rouen·Phase 1·NCT00213551·30 enrolled

Oral Mucositis1 trial

Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma

Withdrawn·CChildren's Oncology Group·N/A·NCT00334984

Enteritis1 trial

Therapy of Radiation Enteritis With Glutamine

Unknown status·NNanjing University School of Medicine·N/A·NCT01758783·30 enrolled

Premature Infants1 trial

Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants

Completed·NNICHD Neonatal Research Network·Phase 3·NCT00005775·1,433 enrolled

Cardiac Surgery1 trial

Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery

Completed·YYuejiang Liu·Phase 2·NCT01794884·33 enrolled

Irritable Bowel Syndrome1 trial

Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

Completed·TTulane University·Phase 2·NCT01414244·106 enrolled

Unknown status·YYanzhao·Phase 4·NCT03867214·100 enrolled

Critical Illness1 trial

Enteral Glutamine in Critical Illness

Terminated·CChristiana Care Health Services·Phase 2/3·NCT00318331·20 enrolled

Esophagitis1 trial

Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis

Terminated·MM.D. Anderson Cancer Center·Phase 3·NCT01952847·77 enrolled

Gastric Cancer1 trial

Perioperative Immunonutrition, Phagocytic and Bactericidal Activity of Blood Platelets in Gastric Cancer Patients

Unknown status·MMedical University of Bialystok·N/A·NCT01704664·240 enrolled

Type 2 Diabetes Mellitus1 trial

Novel Type 2 Diabetes Mellitus Preventive Therapies

Completed·—·Phase 1·NCT02351323·12 enrolled

Anemia1 trial

Trial of Oral Glutamine in Patients With Sickle Cell Anemia

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT00131508·27 enrolled

Brain Injury1 trial

Glutamine and Traumatic Brain Injury

Unknown status·—·Phase 1·NCT05569993·60 enrolled

Injury1 trial

Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury.

Not yet recruiting·YYongquan Shi·Phase 2·NCT06617182·150 enrolled

Function1 trial

SNE1725: Can Oral Glutamine Facilitate Early Return of Gut Function

Unknown status·SScarborough General Hospital·N/A·NCT01750138·206 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 1, 2019

ENDARI

NDA NDA208587

Apr 22, 2020

ENDARI

NDA NDA208587

Oct 29, 2020

ENDARI

NDA NDA208587

Jul 8, 2024

L-GLUTAMINE

NDA ANDA215647

Jun 18, 2025

ENDARI

NDA NDA208587

May 14, 2026

L-GLUTAMINE

NDA ANDA219750

May 26, 2026

L-GLUTAMINE

NDA ANDA219722

Aug 19, 2026

L-GLUTAMINE

NDA ANDA215647

Sources

References

[1]
ClinicalTrials.gov — 45 trial records for glutamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — glutamine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for glutamine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA ANDA215647). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Sanofi

glutamine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Trials by Indication[1]

Lymphoma3 trials

Duchenne Muscular Dystrophy2 trials

Trauma2 trials

Diarrhea2 trials

Peripheral Neuropathy2 trials

Neuropathy2 trials

Herpes Labialis1 trial

Neurotoxicity1 trial

Bone Marrow Transplant1 trial

Propionic Acidemia1 trial

Imaging1 trial

Side Effects1 trial

Short Bowel Syndrome1 trial

Stem Cell Transplant1 trial

Intensive Care Unit1 trial

Low Birth Weight1 trial

Dyspepsia1 trial

Pre-Term1 trial

Effectiveness1 trial

Toxicity1 trial

Diffuse Large B-Cell Lymphoma1 trial

Metabolism1 trial

Oral Mucositis1 trial

Enteritis1 trial

Premature Infants1 trial

Cardiac Surgery1 trial

Irritable Bowel Syndrome1 trial

Periodontitis1 trial

Safety and Efficacy1 trial

Pneumonia1 trial

Critical Illness1 trial

Esophagitis1 trial

Gastric Cancer1 trial

Type 2 Diabetes Mellitus1 trial

Anemia1 trial

Brain Injury1 trial

Injury1 trial

Function1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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