Clinical Trials

Numerous clinical trials evaluate L-glutamine across metabolic, gastrointestinal, oncological, and hematological conditions, including sickle cell disease, advanced pancreatic adenocarcinoma, chronic lymphocytic leukemia, critical illness, and colonic diverticulosis. Spanning Early Phase 1 to Phase 4, these studies are sponsored by academic medical centers, government agencies such as the NIAID, and pharmaceutical entities including Emmaus Medical and Novartis. Overall recruitment statuses range from completed and active non-recruiting studies to actively recruiting and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05972291 RECRUITING
Gulf War Illness; Irritable Bowel Syndrome; Gastrointestinal Symptoms
VA Office of Research and Development
 2023-10-16
NCT04305769 RECRUITING
Clostridioides Difficile Infection; Clostridium Difficile Infection; Clostridium Difficile Diarrhea; Clostridia Difficile Colitis
University of Virginia
 2021-06-01 PHASE2
NCT06027242 RECRUITING
Gastric Cancer; Immunonutrition; Gastrostomy
National Taiwan University Hospital
 2023-02-21
NCT04883515 RECRUITING
Obesity; Insulin Resistance
University Hospital, Rouen
 2023-03-01
NCT07020754 COMPLETED
Radiation Induced Oral Mucositis; Oral Mucositis; Oral Mucositis Due to Radiation
Ain Shams University
 2025-04-01 PHASE2
NCT07210450 COMPLETED
Pulmonary Artery Pressure; Thalassemia; Non-transfusion Dependent Thalassemia
Mazandaran University of Medical Sciences
 2023-08-15 PHASE2; PHASE3
NCT05808010 UNKNOWN
Chronic Atrophic Gastritis
Shandong Provincial Hospital
 2023-06-07
NCT04634539 COMPLETED
Advanced Pancreatic Adenocarcinoma; Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma
Jun Gong, MD
 2021-05-13 PHASE1
NCT03967795 COMPLETED
Enteral Nutrition; Intensive Care Unit; Biomarkers
Centre Hospitalier Universitaire de Besancon
 2019-11-28
NCT05371184 COMPLETED
Sickle Cell Disease
Ain Shams University
 2022-01-04 PHASE4
NCT05106101 COMPLETED
Diverticulosis, Colonic
Emmaus Medical, Inc.
 2019-07-19 PHASE1
NCT05586646 UNKNOWN
Pressure Ulcer
Air Force Specialized Hospital, Cairo, Egypt
 2022-04-01
NCT04785989 Recruiting
Chronic Lymphocytic Leukemia
University of Wisconsin Madison
 2022-06-13 --
NCT05140772 UNKNOWN
Drug Effect
Menoufia University
 2020-06-01 PHASE2; PHASE3
NCT00985205 UNKNOWN
Burns
Daren K. Heyland
 2010-12 PHASE3
NCT04560309 COMPLETED
Coronary Artery Bypass; Cardiopulmonary Bypass; Coronary Artery Disease
National Cardiovascular Center Harapan Kita Hospital Indonesia
 2021-01-01 PHASE3
NCT05494541 Completed
Sickle Cell Disease
Novartis Pharmaceuticals|Novartis
 2021-08-30 --
NCT05833022 Completed
Sickle Cell Disease
Novartis Pharmaceuticals|Novartis
 2021-07-30 --
NCT04684381 COMPLETED
Sickle Cell Disease; Pharmacokinetics
Emmaus Medical, Inc.
 2021-01-04 PHASE4
NCT04634539 Active not recruiting
Advanced Pancreatic Adenocarcinoma|Pancreatic Cancer|Pancreatic Ductal Adenocarcinoma
Jun Gong MD|Emmaus Medical Inc.|Cedars-Sinai Medical Center
 2021-05-13 Phase 1
NCT03947879 UNKNOWN
Diabetes Mellitus, Type 2
Hawaii Pacific Health
 2019-05 PHASE1
NCT06065566 COMPLETED
Insufficiency;Cardiac
Instituto Mexicano del Seguro Social
 2020-02-04
NCT04019769 WITHDRAWN
Eczema; MTOROC1 Signaling
National Institute of Allergy and Infectious Diseases (NIAID)
 2020-03-12 EARLY_PHASE1
NCT04684381 Completed
Sickle Cell Disease|Pharmacokinetics
Emmaus Medical Inc.
 2021-01-04 Phase 4
NCT04701463 COMPLETED
Amino Acid; Body Weight Changes; Skin Manifestations; Obesity; Postmenopausal Disorder
Azienda di Servizi alla Persona di Pavia
 2020-01-15
NCT04274114 TERMINATED
Generalized Anxiety Disorder
Hospital Universitario Dr. Jose E. Gonzalez
 2019-01-18 PHASE2
NCT04019184 COMPLETED
Cardiac Surgery; Acute Kidney Injury
University Hospital Muenster
 2019-07-18 PHASE3
NCT03341169 UNKNOWN
Aortic Valve Stenois
Yonsei University
 2018-03-20
NCT05106101 Completed
Diverticulosis Colonic
Emmaus Medical Inc.
 2019-07-19 Phase 1
NCT02998931 COMPLETED
Critical Illness; Enteral Nutrition; Multiple Organ Failure; Infection Complication; Inflammation
Shahid Beheshti University
 2016-11-10 PHASE3
NCT01552291 COMPLETED
Malnourishment; Gastrointestinal Tumors
Insel Gruppe AG, University Hospital Bern
 2012-05 PHASE4
NCT03113240 COMPLETED
Critical Illness; Enteral Nutrition; Intestinal Permeability
Shahid Beheshti University
 2017-04-01 PHASE3
NCT02838979 COMPLETED
Cardiovascular Disease; Sarcopenia; Endothelial Dysfunction; Muscle Mitochondrial Function; Kidney Disease
University of Washington
 2016-02-25 PHASE2
NCT02053350 TERMINATED
Clostridium Difficile Infection
University of Virginia
 2015-04 PHASE2
NCT01701193 COMPLETED
Pelvic Adhesions
Temple Therapeutics BV
 2015-02-15 PHASE1; PHASE2
NCT03589495 COMPLETED
Systemic Inflammatory Response Syndrome
Ain Shams University
 2015-07-30 PHASE4
NCT03015077 COMPLETED
Head and Neck Cancer
Kaohsiung Medical University Chung-Ho Memorial Hospital
 2014-07
NCT01832636 COMPLETED
Malnutrition; Environmental Enteropathy; Diarrhea
Children's Hospital Medical Center, Cincinnati
 2013-10 PHASE3
NCT01576003 COMPLETED
Bloodstream Infections; Short Bowel Syndrome; Development; Nutrition; Biological Markers
Children's Hospital Medical Center, Cincinnati
 2012-04
NCT02215083 WITHDRAWN
Peripheral Neuropathy
Eastern Regional Medical Center
 2014-08 PHASE1
NCT02491931 COMPLETED
Ischemic Heart Disease
Instituto Mexicano del Seguro Social
 2013-01
NCT01503320 COMPLETED
Acute Pancreatitis
Asian Institute of Gastroenterology, India
 2012-01
NCT03166956 COMPLETED
Critical Care
Chung Shan Medical University
 2012-06-01
NCT01750138 UNKNOWN
Gut Function
Scarborough General Hospital
 2011-06
NCT01048905 COMPLETED
Pulmonary Hypertension; Sickle Cell Disease; Thalassemia
UCSF Benioff Children's Hospital Oakland
 2009-03 PHASE2
NCT01179217 COMPLETED
Sickle Cell Anemia; Sickle ß0-Thalassemia
Emmaus Medical, Inc.
 2010-05 PHASE3
NCT01087658 COMPLETED
Colorectal Neoplasms
Sanofi
 2010-02 PHASE3
NCT00922688 UNKNOWN
Colon Carcinoma
Medical Center Alkmaar
 2010-12
NCT01478126 COMPLETED
Coronary Artery Disease
Meshalkin Research Institute of Pathology of Circulation
 2012-01 PHASE3
NCT01250782 UNKNOWN
Trauma ICU Patients
Hospital Universitari Son Dureta
 2010-10 PHASE2
NCT01353638 TERMINATED
End Stage Renal Disease
Christoph Aufricht
 2011-04 PHASE1; PHASE2
NCT00913692 TERMINATED
Herpes Labialis; Herpes Simplex Virus
National Institute of Allergy and Infectious Diseases (NIAID)
 2009-06 PHASE2
NCT00647036 COMPLETED
Surgical Infants Requiring Total Parenteral Nutrition
Institute of Child Health
 2009-07 PHASE4
NCT01092039 COMPLETED
Common Cold
Xigo Health LLC
 2010-03
NCT00131508 TERMINATED
Anemia, Sickle Cell
St. Jude Children's Research Hospital
 2004-05 PHASE2
NCT00875797 TERMINATED
Critically Ill
University Medical Centre Ljubljana
 2004-10 PHASE4
NCT00586209 TERMINATED
Sickle Cell Anemia; Thalassemia
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
 2004-02-06 PHASE2
NCT00125788 COMPLETED
Sickle Cell Anemia; Thalassemia
Emmaus Medical, Inc.
 2004-03 PHASE2
NCT00296621 COMPLETED
Muscular Dystrophy, Duchenne
Assistance Publique - Hôpitaux de Paris
 2006-02 PHASE2
NCT00204971 COMPLETED
Neurologic Injury; Traumatic Brain Injury
University of Wisconsin, Madison
 2003-01 PHASE4
NCT00318331 TERMINATED
Critical Illness; Sepsis; Respiratory Insufficiency
Christiana Care Health Services
 2006-05 PHASE2; PHASE3
NCT00006994 TERMINATED
Cancer-related Problem/Condition; Head and Neck Cancer; Pain
SWOG Cancer Research Network
 2001-11 PHASE3
NCT00003898 COMPLETED
Oral Complications; Unspecified Childhood Solid Tumor, Protocol Specific
Roswell Park Cancer Institute
 1999-01 PHASE2
NCT00005775 COMPLETED
Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Sepsis
NICHD Neonatal Research Network
 1999-07 PHASE3
NCT00178581 TERMINATED
Trauma; Critical Illness; Shock
The University of Texas Health Science Center, Houston
 2005-06 PHASE1
NCT00338221 WITHDRAWN
Diarrhea, Malnutrition
University of Virginia
 2004-08 PHASE3
NCT00133562 WITHDRAWN
Diarrhea, Malnutrition; Other Nutritional Deficiencies
University of Virginia
 2004-08 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-19)

Check the L-Glutamine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an essential precursor for nucleotide synthesis and cellular respiration, L-glutamine fuels mitochondrial oxidative phosphorylation and maintains cellular redox balance through glutathione production. This central metabolic role supports gut mucosal integrity and cellular survival, providing therapeutic utility in managing conditions such as sickle cell disease, critical illness, and advanced gastrointestinal malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.