Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate glycine and its related derivatives across recruiting, active, completed, and terminated statuses. Supported by both pharmaceutical sponsors such as GlaxoSmithKline and academic centers like the University of Illinois at Chicago, these studies target conditions including major depressive disorder, schizophrenia, prostate cancer, obesity, hypertension, perioperative anemia, and SARS-CoV-2. Key investigations range from window-of-opportunity oncology protocols to N-methylglycine for depressive conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06083480 RECRUITING
Osteoarthritis, Knee; Total Knee Arthroplasty; Chronic Postsurgical Pain
Vanderbilt University Medical Center
 2024-12-06 PHASE4
NCT04738422 ENROLLING_BY_INVITATION
Airway Disease
Indiana University
 2020-09-11 PHASE2
NCT07285135 NOT_YET_RECRUITING
Metabolic Dysfunction Associated Fatty Liver Disease
Singapore General Hospital
 2025-12
NCT06959251 RECRUITING
Primary Ciliary Dyskinesia
Instituto Nacional de Enfermedades Respiratorias
 2025-10-02
NCT07575984 RECRUITING
Ischemic Stroke
Pharmasoft
 2025-11-04 PHASE4
NCT07140146 RECRUITING
Peri-implant Mucositis
University of Pavia
 2025-08-30
NCT04740580 RECRUITING
Alzheimer Disease
Baylor College of Medicine
 2022-02-15 EARLY_PHASE1
NCT07451522 RECRUITING
CAD - Coronary Artery Disease; CABG; Analgesia Assessment
Primorsky Regional General Hospital #1
 2025-12-01
NCT07500844 COMPLETED
Peri-implantitis
Research Centre for Medical Genetics, Russian Federation
 2023-02-01
NCT03617718 COMPLETED
Cystic Fibrosis; Asthma; Severe Persistent Asthma; Healthy
Case Western Reserve University
 2018-11-01 PHASE1; PHASE2
NCT07643675 COMPLETED
Older Adults With Cognitive Decline; Insulin Resistance Syndrome; Aging
Brenda Sarahí Beristain Lujano
 2024-12-01
NCT07212855 COMPLETED
Full Arch Fixed Prosthesis
University of Turin, Italy
 2024-09-01
NCT03493178 ACTIVE_NOT_RECRUITING
Mild Cognitive Impairment
Baylor College of Medicine
 2018-04-19 EARLY_PHASE1
NCT07028606 ACTIVE_NOT_RECRUITING
Alveolar Bone Resorption
Al-Azhar University
 2024-05-09 PHASE1
NCT06726902 ENROLLING_BY_INVITATION
Periodontitis
Diana Ibrahim
 2024-03-03
NCT05965076 UNKNOWN
Plaque, Dental
A.O.U. Città della Salute e della Scienza
 2023-02-06
NCT06378346 Recruiting
Prostate Cancer
University of Illinois at Chicago
 2024-05 Phase 2
NCT06998160 COMPLETED
Peri-implantitis; Dental Implant Complications; Periodontal Inflammation; Gingival Diseases
Hui Xie
 2022-07-05
NCT06242535 Recruiting
Insulin Resistance|Obesity|Cardiovascular Diseases|Cognitive Impairment|Physical Disability|Depression|Inflammation|Hormone Deficiency|Physical Inactivity|Hyperlipidemias|Hypertension|Overeating
Hoskinson Health and Wellness Clinic|Buck Institute for Research on Aging|University of Wyoming
 2023-07-27 Early Phase 1
NCT05900635 UNKNOWN
Anemia of Chronic Kidney Disease
Alexandria University
 2022-10-01 PHASE4
NCT05799651 Active not recruiting
SARS-CoV-2
Glycovax Pharma Inc.|Government of Canada|JSS Medical Research Inc.|Avance Clinical Pty Ltd.|Seppic
 2023-04-28 Phase 1
NCT04703036 TERMINATED
Covid19
Baylor College of Medicine
 2021-01-11 EARLY_PHASE1
NCT05801315 COMPLETED
Peri-implant Mucositis
University of Siena
 2020-03-01
NCT03745326 TERMINATED
Gastrointestinal Cancer; Pancreatic Cancer; Gastric Cancer; Colon Cancer; Rectal Cancer
National Cancer Institute (NCI)
 2019-05-16 PHASE1; PHASE2
NCT03166228 COMPLETED
Hypertension
Assiut University
 2018-01-05 PHASE2
NCT04658134 UNKNOWN
Morbid Obesity; Glycine; Metabolic Disorder
Singapore General Hospital
 2021-01-20
NCT05574218 COMPLETED
Peri-Implantitis
Universidad Complutense de Madrid
 2013-01
NCT04443673 TERMINATED
COVID-19; SARS-CoV Infection; SARS (Severe Acute Respiratory Syndrome); SARS Pneumonia; ARDS, Human; Pneumonia, Viral
Instituto Nacional de Enfermedades Respiratorias
 2020-06-15
NCT03850314 UNKNOWN
Metabolic Syndrome; Dyslipidemias; Diabetes Mellitus; Obesity; Atherosclerosis
Prof. Tony hayek MD
 2019-03 PHASE2; PHASE3
NCT03749096 WITHDRAWN
Stiff-Person Syndrome
Mayo Clinic
 2018-12-07 PHASE3
NCT03347513 UNKNOWN
Pregnancy Complications; Anemia, Iron Deficiency; H Pylori Infection
Kasr El Aini Hospital
 2017-11-25 PHASE4
NCT01870193 COMPLETED
Aging
Rajagopal V Sekhar
 2013-04-23 EARLY_PHASE1
NCT02484456 COMPLETED
Major Depression
National Institute of Mental Health (NIMH)
 2015-10-14 PHASE2
NCT02348775 COMPLETED
HIV Infection; Erythrocyte Glutathione Deficiency
Baylor College of Medicine
 2014-11 PHASE1
NCT02348762 COMPLETED
Aging; Erythrocyte Glutathione Deficiency; Muscle Weakness
Baylor College of Medicine
 2014-11 PHASE1
NCT03353441 COMPLETED
Healthy; Stress, Psychological; Cognitive Impairment
Daacro
 2017-11-15
NCT03180775 UNKNOWN
Atherosclerosis; Diet Modification; Serum; Disease
Rambam Health Care Campus
 2017-07-01
NCT05810558 COMPLETED
Peri-implant Mucositis
Ohio State University
 2016-06-16
NCT02590224 COMPLETED
Iron Deficiency Anemia
Assiut University
 2016-01-01 PHASE4
NCT01720316 COMPLETED
Schizo-affective Disorder; Bipolar Disorder
Mclean Hospital
 2012-12-10 PHASE2
NCT02496377 COMPLETED
Allogenic Transfusion; Perioperative Anaemia; Knee Arthroplasty; Hip Arthroplasty
University Hospital, Montpellier
 2014-08-29
NCT02304432 COMPLETED
Schizophrenia; Bipolar Disorder
Mclean Hospital
 2015-09-27 EARLY_PHASE1
NCT02149953 COMPLETED
Pregnancy
University of British Columbia
 2014-09-19
NCT02655276 COMPLETED
Motor Activity; Attention Deficit; Stress, Psychological
Eberhard Schulz
 2016-01
NCT00338598 COMPLETED
Alcoholism; Schizophrenia
Yale University
 2003-06 PHASE2
NCT03031756 COMPLETED
Halitosis
Near East University, Turkey
 2015-01
NCT01503359 COMPLETED
Schizophrenia
Medical University of Lodz
 2012-01 PHASE2
NCT02205619 COMPLETED
Dental Diseases
University of Roma La Sapienza
 2013-09 PHASE2; PHASE3
NCT01610011 COMPLETED
Schizophrenia; Psychotic Disorders
Mclean Hospital
 2010-07
NCT02315391 COMPLETED
Healthy Elderly Muscle; Anabolically Resistant Elderly Muscle
Société des Produits Nestlé (SPN)
 2012-09
NCT01425463 COMPLETED
Iron Deficiency Anemia
Sanol GmbH
 2011-03 PHASE3
NCT01417481 TERMINATED
Cystic Fibrosis
Instituto Nacional de Enfermedades Respiratorias
 2012-03 PHASE2
NCT01501942 COMPLETED
Asthma
AIM Therapeutics Inc.
 2012-02 PHASE2
NCT01476514 TERMINATED
Hyperekplexia
Insel Gruppe AG, University Hospital Bern
 2011-10
NCT01461109 COMPLETED
Parkinson Disease; Alzheimer Disease
Institute for Neurodegenerative Disorders
 2011-08 PHASE1
NCT00988728 WITHDRAWN
Schizophrenia
Merck Sharp & Dohme LLC
 2011-02 PHASE2
NCT00538070 COMPLETED
Schizophrenia
Massachusetts General Hospital
 2007-08
NCT01116310 UNKNOWN
Postmenopausal Women With Moderate Vasomotor Symptoms
Laboratorios Casen-Fleet S.L.U.
 2010-04 PHASE4
NCT01913808 COMPLETED
Postoperative Anemia; Osteoarthritis, Knee
Parc de Salut Mar
 2011-01 PHASE4
NCT00913692 TERMINATED
Herpes Labialis; Herpes Simplex Virus
National Institute of Allergy and Infectious Diseases (NIAID)
 2009-06 PHASE2
NCT00133406 UNKNOWN
Diarrheal Disorder
University of Virginia
 2006-06 PHASE3
NCT01355198 COMPLETED
HIV Infection; Erythrocyte Glutathione Deficiency
Baylor College of Medicine
 2010-08 PHASE1
NCT00977353 COMPLETED
Major Depressive Disorder; Depression; Major Depression
China Medical University Hospital
 2009-04 PHASE2
NCT00877812 COMPLETED
Vitamin B6 Deficiency
University of Florida
 2008-01
NCT01124383 COMPLETED
The Absorption of Glycine in Operative Hysteroscopy
CHU de Quebec-Universite Laval
 2008-08
NCT00291226 COMPLETED
Schizophrenia Prodrome
Yale University
 2006-03 PHASE2; PHASE3
NCT00218465 COMPLETED
Nicotine Dependence
Massachusetts General Hospital
 2006-08 PHASE2
NCT01031927 COMPLETED
Obsessive Compulsive Disorder
China Medical University Hospital
 2007-06 PHASE2
NCT00945503 COMPLETED
Schizophrenia
GlaxoSmithKline
 2008-05-19 PHASE1
NCT00929370 TERMINATED
Schizophrenia
GlaxoSmithKline
 2008-07 PHASE1
NCT00575848 TERMINATED
Schizophrenia; Schizoaffective Disorder
North Suffolk Mental Health Association
 2007-12 PHASE1
NCT00635102 COMPLETED
Alcohol Dependence
Yale University
 1997-10
NCT00000372 WITHDRAWN
Schizophrenia
Massachusetts General Hospital
 1998-03 PHASE3
NCT00268749 COMPLETED
Schizophrenia
Yale University
 2002-07 PHASE2
NCT00222235 COMPLETED
Schizophrenia; Schizoaffective Disorder
University of Maryland, Baltimore
 2000-01 PHASE2; PHASE3
NCT00276263 WITHDRAWN
Schizophrenias; Psychoses; Psychotic Disorders; Schizophrenic Disorders
Herzog Hospital
 2006-08 PHASE2
NCT00405535 COMPLETED
Obsessive Compulsive Disorder
Nathan Kline Institute for Psychiatric Research
 2004-06
NCT00005658 COMPLETED
Psychotic Disorder; Schizoaffecitve Disorder; Schizophrenia
National Institute of Mental Health (NIMH)
 2000-05 PHASE2
NCT00323999 UNKNOWN
Menorrhagia; Fibroid; Polyps
Ullevaal University Hospital
 2004-12
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 2025-12-11)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an inhibitory neurotransmitter and an obligate co-agonist at NMDA receptors, glycine binds to specific ionotropic receptor targets to modulate chloride influx and downstream excitatory glutamatergic neurotransmission. This receptor modulation regulates synaptic plasticity, metabolic homeostasis, and protein synthesis, supporting its therapeutic investigation in clinical trials for major depressive disorder, schizophrenia, and metabolic disorders.

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.