Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate the therapeutic applications of reduced L-glutathione across diverse indications, including diabetes mellitus, ischemia-reperfusion injury, dermatological conditions, autistic disorder, and viral infections such as COVID-19. Sponsored predominantly by university medical centers and academic research institutes globally, these studies assess physiological parameters ranging from liver transplantation injury to glycemic and inflammatory profiles. Recruitment statuses vary from active and recruiting to completed, with select studies withdrawn or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07304440 RECRUITING
Autism Spectrum Disorder; Autism; ASD; Autism Spectrum Disorder (ASD)
Adia Med of Winter Park LLC
2026-05-01 PHASE1; PHASE2
NCT07572890 RECRUITING
Chronic Kidney Disease; Kidney Disease; Kidney Disease, Chronic; Chronic Kidney Disease (CKD); CKD
Adia Med of Winter Park LLC
2026-05-18 PHASE1
NCT02971046 ACTIVE_NOT_RECRUITING
Healthy
The Hospital for Sick Children
2020-10-01
NCT05266417 RECRUITING
Parkinson Disease
Gateway Institute for Brain Research
2022-02-07 PHASE2
NCT07064005 RECRUITING
Parkinsons Disease (PD)
Pravat Mandal
2026-03-23 PHASE1
NCT06620523 RECRUITING
Renal Failure; Coronary Artery Disease; Surgery; Surgery-Complications
George Washington University
2024-07-18 PHASE2
NCT06922669 RECRUITING
Drug Induced Liver Injury
General Hospital of Shenyang Military Region
2025-06-24
NCT07448415 NOT_YET_RECRUITING
Melasma
Assiut University
2026-02 PHASE2; PHASE3
NCT06957808 RECRUITING
Schizophrenia Disorders
King's College London
2025-01-10
NCT07595705 RECRUITING
Gingival Pigmentation; Depigmentation; Vitamin C; Glutathione
Cairo University
2025-08-01 PHASE2
NCT06896422 RECRUITING
Non-Small Cell Lung Cancer; Chemotherapy; PD1 Antibody; Glutathione
The First Affiliated Hospital of Zhengzhou University
2025-06-01 PHASE1
NCT07622316 RECRUITING
Autism Spectrum Disorder; Autism; ASD; Autism Spectrum Disorder (ASD)
Greater Atlanta Integrative Pediatrics
2026-06-01 PHASE1
NCT07690124 NOT_YET_RECRUITING
Performance Recovery; Exercise-induced Inflammation; Exercise-induced Oxidative Stress
University of Thessaly
2026-09-01
NCT07379216 RECRUITING
Skin Condition; Anti-Oxidative Stress
TCI Co., Ltd.
2026-01-24
NCT04740580 RECRUITING
Alzheimer Disease
Baylor College of Medicine
2022-02-15 EARLY_PHASE1
NCT07162623 COMPLETED
Hyperpigmentation
NovoBliss Research Pvt Ltd
2025-09-02
NCT05241262 RECRUITING
Mitochondrial Disease
Michio Hirano, MD
2023-07-06 PHASE1
NCT07202156 RECRUITING
Melasma (Facial Melasma)
The First Affiliated Hospital with Nanjing Medical University
2024-10-20
NCT07302828 COMPLETED
Vitamin C; Glutathione
TCI Co., Ltd.
2025-12-15
NCT07748507 COMPLETED
Gingiival Hyperpigmentation
Krishnadevaraya College of Dental Sciences & Hospital
2025-06-25
NCT07263841 ACTIVE_NOT_RECRUITING
Post Burn Facial Hyperpigmentation
King Edward Medical University
2025-06-01 PHASE2
NCT07221955 NOT_YET_RECRUITING
Effects of Qualia Glutathione+ on Blood Glutathione Levels; Glutathione
Qualia Life Sciences
2025-12-02
NCT07344688 COMPLETED
Healhty
Universitas Padjadjaran
2025-08-22
NCT07724067 COMPLETED
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
University of Bari
2024-05-01
NCT05371288 WITHDRAWN
COVID-19
University of California, Irvine
2025-06 EARLY_PHASE1
NCT06345950 COMPLETED
Bioavailability Heathy Volunteers; Safety
Factors Group of Nutritional Companies Inc.
2022-06-21
NCT03493178 ACTIVE_NOT_RECRUITING
Mild Cognitive Impairment
Baylor College of Medicine
2018-04-19 EARLY_PHASE1
NCT05604586 COMPLETED
Skeletal Muscle Performance; Gene Polymorphisms
Poznan University of Life Sciences
2022-05-01
NCT04020224 WITHDRAWN
Safety Issues
Swiss Transfusion SRC
2024-01
NCT06205030 Not yet recruiting
Diabetes Mellitus Type 2|Insulin Resistance
Kerman Medical University|Afzalipour Hospital
2024-06-14 Phase 4
NCT06313164 COMPLETED
Type 2 Diabetes
S.LAB (SOLOWAYS)
2023-06-20
NCT05954052 TERMINATED
Autism Spectrum Disorder
University of Chicago
2019-07-01 PHASE4
NCT05693948 COMPLETED
Healthy
USMARI Research & Innovation Centre
2022-09-01
NCT06419712 COMPLETED
Post-COVID19 Condition
Escuela Militar de Graduados de Sanidad, SEDENA
2022-11-25
NCT03166371 WITHDRAWN
Malnutrition
Emory University
2022-02
NCT02505477 COMPLETED
Schizophrenia; Cognitive Deficits; Schizophrenia; Negative Type
University of California, Los Angeles
2017-02-06 PHASE4
NCT05511402 UNKNOWN
Parkinson Disease
Saglik Bilimleri Universitesi
2022-08-25
NCT05926245 COMPLETED
Glutathione-cyclodextrin Complex Absorption
Western University of Health Sciences
2022-07-11 PHASE1
NCT02827747 WITHDRAWN
Keratoconus
University of Miami
2021-08-01 PHASE2
NCT04015557 SUSPENDED
CBS Deficiency
Hospital de Clinicas de Porto Alegre
2022-02-11 PHASE1; PHASE2
NCT04672447 COMPLETED
Menopause; Cardiovascular Risk Factor
Texas Tech University
2020-07-01
NCT03596125 TERMINATED
Preterm Delivery
Nantes University Hospital
2018-11-05 PHASE2; PHASE3
NCT04816487 UNKNOWN
Discoloration, Tooth
Cairo University
2021-05-01
NCT04386187 COMPLETED
Type 2 Diabetes
University of California, San Diego
2020-07-28
NCT01967667 COMPLETED
Schizophrenia
University of Maryland, Baltimore
2014-04
NCT04389788 COMPLETED
Periorbital Hypermelanosis
Sohag University
2020-02-12
NCT03725241 COMPLETED
Healthy
University of North Texas, Denton, TX
2018-10-29
NCT04175873 COMPLETED
Infertility; Anesthesia; Oxidative Stress; Pain, Postoperative
Kahramanmaras Sutcu Imam University
2019-11-25
NCT03486054 WITHDRAWN
Anemia
Swiss Transfusion SRC
2019-06
NCT02584283 COMPLETED
Liver Failure; End Stage Liver Disease; Biliary Tract Diseases
Robert J. Porte
2016-01 PHASE3
NCT02848417 UNKNOWN
Gulf War Syndrome
South Florida Veterans Affairs Foundation for Research and Education
2016-04 PHASE1; PHASE2
NCT01870193 COMPLETED
Aging
Rajagopal V Sekhar
2013-04-23 EARLY_PHASE1
NCT02757833 WITHDRAWN
Female, Late Life Depression
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
2019-02-15 PHASE1
NCT02251041 COMPLETED
Reperfusion Injury
Universitaire Ziekenhuizen KU Leuven
2014-09 PHASE2
NCT03020719 COMPLETED
Cystic Fibrosis
University of Minnesota
2017-06-14 PHASE2
NCT02348775 COMPLETED
HIV Infection; Erythrocyte Glutathione Deficiency
Baylor College of Medicine
2014-11 PHASE1
NCT04105504 COMPLETED
Glutathione; Skin Whitening
Dr Irma Bernadette S Sitohang
2018-04-08 PHASE1
NCT03374150 UNKNOWN
Low-Calorie Diet; Diet, High-Protein; Obesity; Pituitary; Weight Cycling
Indonesia University
2017-05-26
NCT02948673 COMPLETED
Type 2 Diabetes; Oxidative Stress; Mitochondrial Reactive Oxygen Species Production
University of Copenhagen
2016-05
NCT02794389 COMPLETED
Anorexia Nervosa; Compulsive Behavior
University of Oxford
2016-03
NCT02321579 UNKNOWN
Liver Cirrhosis; Liver Cancer
Taichung Veterans General Hospital
2014-12
NCT02662816 COMPLETED
Assay Muscle; Liver Glutathione in Healthy Human
University Hospital, Clermont-Ferrand
2016-06
NCT02438956 COMPLETED
Improvement in Immune Cell Function in Elderly Humans
University of Florida
2015-10
NCT02424708 COMPLETED
Parkinson's Disease
Bastyr University
2015-04 PHASE2
NCT03121222 COMPLETED
Glutathione Metabolism Anemias
Aristotle University Of Thessaloniki
2015-11-01 PHASE2
NCT01398748 COMPLETED
Parkinson's Disease (PD)
Bastyr University
2012-07 PHASE1
NCT00069134 COMPLETED
Protein-energy Malnutrition; Kwashiorkor; Marasmus
Baylor College of Medicine
2003-06
NCT00287365 COMPLETED
Mild Asthma
University of North Carolina, Chapel Hill
2006-01
NCT02316925 WITHDRAWN
Improvement in Immune Cell Function in Elderly Humans
University of Florida
2015-05
NCT02278822 COMPLETED
Healthy
Milton S. Hershey Medical Center
2014-11
NCT02324426 COMPLETED
Parkinson's Disease
University of Washington
2014-12 PHASE1
NCT02310971 WITHDRAWN
Pancreatic Carcinoma Stage I; Pancreatic Carcinoma Stage II
Prima BioMed Ltd
2015-02 PHASE2
NCT01521143 TERMINATED
Epithelial Ovarian Cancer
Prima BioMed Ltd
2012-01 PHASE2
NCT01265563 COMPLETED
Diabetic Nephropathy; Proteinuria; Oxidative Stress
VA Office of Research and Development
2011-01 PHASE2
NCT02125045 COMPLETED
Health Subjects With Cardiovascular Risk Factors
Niguarda Hospital
2014-02 PHASE3
NCT01402570 COMPLETED
Post-polio Syndrome; Physical Activity; Depression; Pain; Sleep Disorders
University of Michigan
2011-08
NCT01071486 WITHDRAWN
Busulfan Pharmacokinetic Analysis; GST Genetic Polymorphism
Rambam Health Care Campus
2009-08 PHASE4
NCT00889538 COMPLETED
Autism; Severe Behavior Disorder
University of Louisville
2009-04
NCT02311907 COMPLETED
Chemotherapeutic Agent Toxicity; Neuropathy; Neurotoxicity Syndrome; Pain; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Primary Peritoneal Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIC Primary Peritoneal Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Cancer; Stage IV Primary Peritoneal Cancer
Alliance for Clinical Trials in Oncology
2009-12 PHASE3
NCT01550432 COMPLETED
Obesity; Hyperlipidemia; Insulin Resistance; Hypertension
Stanford University
2011-06
NCT01450267 UNKNOWN
Cystic Fibrosis
Serafino A. Marsico
2010-06 PHASE3
NCT01403506 UNKNOWN
Disorder Related to Renal Transplantation
Shahid Beheshti University of Medical Sciences
2011-04 PHASE3
NCT02029521 COMPLETED
Cystic Fibrosis
Clark Bishop
2011-03
NCT01044277 COMPLETED
Healthy Adults
Milton S. Hershey Medical Center
2010-02
NCT01355198 COMPLETED
HIV Infection; Erythrocyte Glutathione Deficiency
Baylor College of Medicine
2010-08 PHASE1
NCT01251315 COMPLETED
Oxidative Stress
Charles Drew University of Medicine and Science
2010-12 PHASE1
NCT00266331 COMPLETED
Breast Cancer
Nathalie Johnson
2004-10 PHASE2
NCT00858273 COMPLETED
Diabetes Mellitus, Type 1
Nemours Children's Clinic
2008-03
NCT01142024 COMPLETED
Nephropathy; Oxidative Stress
Huashan Hospital
2010-03
NCT00254176 UNKNOWN
Sepsis; Bronchopulmonary Dysplasia; Necrotizing Enterocolitis; Retinopathy of Prematurity; Systemic Inflammatory Response Syndrome
University of California, Los Angeles
2006-09 PHASE2; PHASE3
NCT00607061 TERMINATED
Low Birth Weight
Nantes University Hospital
2007-10
NCT00506688 COMPLETED
Cystic Fibrosis
Mukoviszidose Institut gGmbH
2007-07 PHASE2
NCT01016080 COMPLETED
Skin Whitening
Chulalongkorn University
2009-02 PHASE1
NCT00858897 COMPLETED
Diabetes Mellitus, Type 1
Nemours Children's Clinic
2007-06
NCT01116596 COMPLETED
Chronic Pain; Elderly
University Hospital, Clermont-Ferrand
2007-02 PHASE1
NCT00692315 COMPLETED
Autistic Disorder
Arkansas Children's Hospital Research Institute
2006-09
NCT01177319 COMPLETED
Parkinson's Disease
University of South Florida
2003-09 PHASE2
NCT00910442 COMPLETED
HIV Infection
UPECLIN HC FM Botucatu Unesp
2002-02 PHASE2
NCT01506765 COMPLETED
Schizophrenia
Centre Hospitalier Universitaire Vaudois
2003-08 PHASE1
NCT00227058 COMPLETED
Seasonal Allergic Rhinitis
University of Mississippi Medical Center
2005-01
NCT00127309 COMPLETED
Alcohol Drinking
Piyavate Hospital
2005-06
NCT00323583 UNKNOWN
Adenocarincoma of Pancreas; Stage III Pancreatic Cancer; Stage IVA Pancreatic Cancer; Stage IVB Pancreatic Cancer
Seattle Cancer Treatment and Wellness Center
2006-05 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-21)

Check the GSH (L-Glutathione reduced) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an endogenous tripeptide antioxidant, reduced L-glutathione serves as a substrate for glutathione peroxidase and glutathione S-transferases, directly scavenging reactive oxygen species and conjugating electrophilic compounds to prevent intracellular lipid peroxidation and oxidative damage. By maintaining cellular redox homeostasis and preventing oxidative cell injury, this detoxifying mechanism directly supports clinical interventions aimed at reducing tissue damage in ischemia-reperfusion injury and improving metabolic outcomes in type 2 diabetes mellitus.

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>).

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