Clinical Trials

Numerous clinical trials evaluate the therapeutic potential of resveratrol across a broad spectrum of indications, including metabolic, cardiovascular, inflammatory, and oncological disorders. Spanning Early Phase 1 through Phase 4, these studies encompass active recruiting, completed, and terminated statuses, and are supported by academic, institutional, and corporate sponsors. These investigations assess various administration routes, such as oral regimens, mouthwashes, and nasal sprays, to determine the compound's clinical efficacy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07592767 NOT_YET_RECRUITING
Parkinson's Disease
Georgetown University
2026-06-01 PHASE2
NCT07100613 RECRUITING
Oral Lichen Planus; Oral Lichen Planus Related Stress; Oral Mucosal Disease; Oral Pain
University of Palermo
2024-09-04 PHASE2
NCT06470061 NOT_YET_RECRUITING
Alzheimer Disease; Mild Cognitive Impairment; Cognitive Decline
Zaparackas and Knepper LTD
2024-07 PHASE2
NCT06585865 RECRUITING
Sarcopenia; Anabolic Resistance
Texas Tech University
2025-06-13
NCT04449198 RECRUITING
Type 1 Diabetes
Augusta University
2020-10-14 EARLY_PHASE1
NCT07395921 NOT_YET_RECRUITING
Inflammation Biomarkers; Cardiometabolic Health Indicators; Antioxidant Status, Inflammation; Antioxidant Capabilities; Inflammaging
Center for Research and Innovation Viña Concha y Toro
2026-06-01
NCT07060157 NOT_YET_RECRUITING
Melasma
Assiut University
2025-07-22
NCT05377242 COMPLETED
Gulf War Illness
University of Alabama at Birmingham
2023-05-31
NCT07569744 COMPLETED
Type 2 Diabetes Mellitus; Endothelial Dysfunction
Universitas Sriwijaya
2026-05-01
NCT07393802 NOT_YET_RECRUITING
Mouthwash; Chlorhexidine; Biofilm Formation; Periodontal Health
University of Baghdad
2026-03 PHASE3
NCT07487623 RECRUITING
Liver Disease Chronic; HEPATITIS C VIRUS CHRONIC INFECTION
University of Guadalajara
2025-10-11
NCT07397026 ACTIVE_NOT_RECRUITING
Periodontitis Stage III
Hagar Ahmed Ali Mohammed Elzain
2025-08-09 PHASE1
NCT07089381 RECRUITING
Rheumatic Arthritis; Rheumatoid Arthritis (RA) Prevention; Inflamation; Antioxidant; Anti Oxidative Stress; Anti Aging; C Reactive Protein; Methotrexate; Quality of Life Outcomes
Ain Shams University
2025-08-01
NCT06481696 UNKNOWN
Unexplained Infertility
Andros Day Surgery Clinic
2024-06-01
NCT06521333 COMPLETED
Mucogingival Defects
Cairo University
2024-05-14
NCT06250283 COMPLETED
Low Bone Mass
University of Delaware
2024-02-02
NCT07182370 ACTIVE_NOT_RECRUITING
Menopause Related Conditions; Cardiovascular Risk
National Research Council, Spain
2024-01-15
NCT05808387 UNKNOWN
Coronary Artery Disease; Menopause; Endothelial Dysfunction
InCor Heart Institute
2023-03-06
NCT06235294 UNKNOWN
Aging; Infertility
Unidade Local de Saúde de Coimbra, EPE
2024-09
NCT06882564 RECRUITING
Halitosis; Mouth Disease; Plaque Induced Gingival Disease; Bleeding Gum; Peridontal Disease
Al-Mustansiriyah University
2025-01-05 PHASE3
NCT06723119 RECRUITING
Effect of Resveratrol on Performance and Recovery
University of Central Florida
2024-10-01
NCT06779214 NOT_YET_RECRUITING
Irritable Bowel Syndrome - Diarrhoea
Peking University
2025-02-28
NCT06954649 COMPLETED
Cholesterol Lowering; LDL Level
Centro de Edafología y Biología Aplicada del Segura
2025-01-14
NCT06828211 ACTIVE_NOT_RECRUITING
Heart Failure; Arterial Hypertension; Osteopenia; Menopause
OMNIFARMA LLC
2024-09-09
NCT06914934 COMPLETED
Ischaemic Heart Desease
S.LAB (SOLOWAYS)
2024-02-01
NCT04421079 COMPLETED
Healthy Control
Icahn School of Medicine at Mount Sinai
2021-01-19 PHASE1
NCT05062486 COMPLETED
Age-related Macular Degeneration
Paul A Knepper, MD PhD
2021-10-04 PHASE2
NCT05500742 UNKNOWN
Aging
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2022-07-22
NCT05410093 UNKNOWN
Primary Ovarian Insufficiency
Affiliated Hospital of Nantong University
2022-02-01
NCT04166396 COMPLETED
Cystic Fibrosis
Virginia Commonwealth University
2020-02-17 EARLY_PHASE1
NCT03933163 COMPLETED
Friedreich Ataxia
Murdoch Childrens Research Institute
2019-05-23 PHASE2
NCT05601180 COMPLETED
Asthma; Chronic Obstructive Pulmonary Disease; Long COVID
Beker Laboratories
2022-10-27
NCT05684848 UNKNOWN
Wheezing; Recurrent Respiratory Tract Infections
Noos S.r.l.
2022-11-01
NCT05653895 COMPLETED
PCOS
Khyber Medical University Peshawar
2022-12-07
NCT06131918 COMPLETED
Peripheral Diabetic Neuropathy
Khyber Medical University Peshawar
2023-01-09 PHASE2
NCT04994561 WITHDRAWN
Aging
Vitality in Aging Research Group, Inc.
2022-06 PHASE1
NCT03436992 COMPLETED
Diabetes Mellitus, Type 1
Augusta University
2018-04-17
NCT05874882 UNKNOWN
Periodontitis
University of Baghdad
2022-12-12 EARLY_PHASE1
NCT06020313 UNKNOWN
Polyphenols; Cardiovascular Diseases; Autonomic Nervous System
Taisy Cinthia Ferro Cavalcante
2023-08
NCT06383442 COMPLETED
Overweight or Obesity
Taipei Medical University
2021-05-25
NCT03743636 COMPLETED
Peripheral Artery Disease
Northwestern University
2018-10-01 PHASE3
NCT06078163 COMPLETED
Sciatic Radiculopathy
University of Palermo
2022-07-01
NCT05761327 COMPLETED
Ulcerative Colitis
Ardahan University
2022-06-03
NCT03597568 COMPLETED
Chronic Kidney Diseases; Endothelial Dysfunction
Diana Jalal
2019-01-01
NCT06095635 COMPLETED
Coronary Artery Disease; Autonomic Nervous System Disease; Blood Pressure; Heart Rate
Universidade Estadual Paulista Júlio de Mesquita Filho
2022-03-10
NCT05172947 COMPLETED
Diabetic Neuropathies
University of Sulaimani
2021-12-05
NCT04654689 COMPLETED
Amyotrophic Lateral Sclerosis
Fundación Universidad Católica de Valencia San Vicente Mártir
2021-11-20 PHASE2
NCT05684848 Recruiting
Wheezing|Recurrent Respiratory Tract Infections
Noos S.r.l.
2022-11-01 Not Applicable
NCT03253913 COMPLETED
Lymphangioleiomyomatosis
University of Cincinnati
2018-03-31 PHASE2
NCT03665740 UNKNOWN
Gulf War Illness
VISN 17 Center of Excellence
2018-08-01 PHASE2
NCT03819517 COMPLETED
Chronic Obstructive Pulmonary Disease
Virginia Commonwealth University
2019-07-01 EARLY_PHASE1
NCT04266353 WITHDRAWN
Chemoprevention
Loma Linda University
2019-04-24
NCT02502253 COMPLETED
Mild Cognitive Impairment; Alzheimer's Disease
Johns Hopkins University
2015-06 PHASE1
NCT04886297 COMPLETED
Dyslipidemias
Sun Yat-sen University
2021-05-01 PHASE3
NCT04799743 UNKNOWN
Covid-19
Hong Kong Baptist University
2021-04-01
NCT02905799 COMPLETED
Knee Osteoarthritis
Assistance Publique - Hôpitaux de Paris
2017-11-09 PHASE3
NCT03090997 UNKNOWN
Postmenopausal; Insulin Resistance
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
2018-02-15
NCT04867252 COMPLETED
PCOS
Khyber Medical University Peshawar
2021-05-03 PHASE2
NCT03762096 ACTIVE_NOT_RECRUITING
Diabetes Mellitus, Type 2; Coronary Artery Disease
MaineHealth
2018-03-06
NCT03563365 TERMINATED
Acne Vulgaris
Yardley Dermatology Associates
2018-06-04 PHASE4
NCT04400890 TERMINATED
COVID-19
Marvin McCreary, MD
2020-09-13 PHASE2
NCT04668274 COMPLETED
Pharmacokinetics; Safety; Food-drug Interaction
Jupiter Orphan Therapeutics Inc.
2021-01-21 PHASE1
NCT04542993 TERMINATED
Covid19; SARS-CoV Infection
Swedish Medical Center
2020-09-08 PHASE2
NCT04456829 COMPLETED
Skin Conditions; Proinflammatory Cytokines
TCI Co., Ltd.
2020-09-17
NCT03866200 TERMINATED
Pseudoachondroplasia
The University of Texas Health Science Center, Houston
2019-06-29 PHASE2
NCT01842399 TERMINATED
Vascular Resistance; Hypertension
National Institute on Aging (NIA)
2015-07-14 PHASE1; PHASE2
NCT04723849 COMPLETED
Childhood Obesity
Universita di Verona
2019-02-01
NCT04386499 COMPLETED
Infertility, Female
University Of Perugia
2019-01-10
NCT04314739 COMPLETED
Cognitive Change; Mood; Systemic Inflammation
Northumbria University
2019-03-19
NCT01914081 UNKNOWN
Dilated Cardiomyopathy
St. Boniface Hospital
2018-10-09 PHASE3
NCT03525379 COMPLETED
Congestive Heart Failure Chronic
University of Alberta
2017-10-26 PHASE2
NCT03728777 COMPLETED
Mitochondrial Myopathies; Fatty Acid Oxidation Defects
Rigshospitalet, Denmark
2018-04-09
NCT02336633 COMPLETED
Huntington Disease
Assistance Publique - Hôpitaux de Paris
2015-07
NCT02909686 COMPLETED
Gulf War Illness
University of Alabama at Birmingham
2016-07
NCT03384329 COMPLETED
Depression
Russian Academy of Medical Sciences
2018-07-04 PHASE4
NCT03448094 COMPLETED
Cognitive Function and Mood; Cerebral Blood Flow; Systemic Inflammation; Gut Microbiota; Overweight and Obesity
Northumbria University
2018-02-06
NCT02123121 COMPLETED
Mitochondrial Function; Physical Function
University of Florida
2015-09 PHASE2
NCT02523274 COMPLETED
Aging
University of Florida
2016-06 PHASE2
NCT03864198 UNKNOWN
Male Infertility
University Of Perugia
2019-01-20
NCT02565979 COMPLETED
Pre-diabetes
Maastricht University Medical Center
2016-04
NCT02219906 COMPLETED
Metabolic Syndrome
Vanderbilt University
2014-05
NCT03446625 COMPLETED
Infertility
IVI Madrid
2018-03-13 PHASE3
NCT03743636 Completed
Peripheral Artery Disease
Northwestern University|American Heart Association
2018-10-01 Phase 3
NCT03349619 COMPLETED
Allergic Rhinitis
Istituto per la Ricerca e l'Innovazione Biomedica
2018-03-05 PHASE4
NCT07634302 COMPLETED
Obesity (Disorder); Knee Osteoarthritis (Knee OA)
Federal State Budgetary Scientific Institution
2017-03-20
NCT02947932 UNKNOWN
Pancreatitis, Acute; Gastrointestinal Disease
First Affiliated Hospital Xi'an Jiaotong University
2016-12 PHASE4
NCT03683108 COMPLETED
Common Cold
Policlinico Hospital
2015-12 PHASE3
NCT02549924 TERMINATED
Type 2 Diabetes Mellitus
University of Guadalajara
2016-09 PHASE2
NCT06961279 COMPLETED
Obesity
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
2013-09-15
NCT03509688 COMPLETED
Hepatitis
The First Hospital of Jilin University
2014-11
NCT04258306 COMPLETED
Nutrient; Excess; Product Use Issue
Bernard Fioretti
2017-10-01
NCT02245932 COMPLETED
Pulmonary Disease, Chronic Obstructive
Maastricht University Medical Center
2015-01
NCT02314208 COMPLETED
Spastic Paraplegia, Hereditary
Institut National de la Santé Et de la Recherche Médicale, France
2015-01-08 PHASE2
NCT01354977 COMPLETED
Type 2 Diabetes Mellitus; Insulin Resistance
Albert Einstein College of Medicine
2008-03 PHASE2
NCT02998918 COMPLETED
Inflammation; Atherosclerosis; Cardiovascular Disease
University of South Carolina
2016-09
NCT03352895 COMPLETED
Chronic Kidney Disease
Dalin Tzu Chi General Hospital
2014-11
NCT02766803 UNKNOWN
PCOS, Insulin Resistance
Poznan University of Medical Sciences
2016-05 PHASE4
NCT02129595 COMPLETED
Pre-diabetes
Maastricht University Medical Center
2014-04
NCT03062163 COMPLETED
Lipolysis
Chulalongkorn University
2017-01-23
NCT02704494 COMPLETED
Diabetic Nephropathy
Shiraz University of Medical Sciences
2016-03 EARLY_PHASE1
NCT02216552 COMPLETED
NAFLD; TYPE 2 DIABETES; METABOLIC SYNDROME
University of Manitoba
2015-08 PHASE2; PHASE3
NCT03546530 COMPLETED
Hepatitis B; Interferon
The First Hospital of Jilin University
2016-06-01
NCT02621554 COMPLETED
Healthy
Max Planck Institute for Human Cognitive and Brain Sciences
2016-04
NCT03541993 COMPLETED
Hypoxia, Altitude; Brain
Northumbria University
2016-06-07
NCT02625376 TERMINATED
AMD; Age-related Macular Degeneration; Choroidal Neovascularisation
Poitiers University Hospital
2015-08-06
NCT02246660 COMPLETED
Peripheral Arterial Disease
Northwestern University
2015-01
NCT01219244 COMPLETED
Mild Cognitive Impairment
Charite University, Berlin, Germany
2010-08 PHASE2; PHASE3
NCT02261844 WITHDRAWN
Liver Cancer
University of Louisville
2015-12 PHASE1; PHASE2
NCT02256540 COMPLETED
Endothelial Dysfunction
University of Colorado, Denver
2014-08
NCT02244879 COMPLETED
Type 2 Diabetes Mellitus; Inflammation; Insulin Resistance; Other Disorders of Bone Density and Structure
University of Turin, Italy
2013-10 PHASE3
NCT01766180 UNKNOWN
Memory Impairment
Neurolgy Institute for Brain Health and Fitness
2013-01
NCT03546075 COMPLETED
Cognitive Change
Northumbria University
2015-05-07
NCT01997762 UNKNOWN
Gestational Diabetes
University of Manitoba
2014-05 PHASE4
NCT02475564 COMPLETED
Endometriosis
Hospital de Clinicas de Porto Alegre
2015-06 PHASE4
NCT02616822 COMPLETED
Endothelial Dysfunction
Hospital Universitario Pedro Ernesto
2013-01 PHASE1
NCT01714102 COMPLETED
Obesity; Insulin Resistance; Metabolic Syndrome
Rockefeller University
2012-10
NCT02415114 COMPLETED
CoQ10 Blood Levels; CoQ10 Blood Levels With Statin Use
KGK Science Inc.
2015-03 PHASE1
NCT02321189 UNKNOWN
Eye Disease
Huazhong University of Science and Technology
2014-10
NCT02944097 COMPLETED
Safety After Oral Intake; Pharmacokinetics After Oral Intake
University of Hohenheim
2015-03 EARLY_PHASE1
NCT03100019 COMPLETED
Hypoxia, Brain
Northumbria University
2014-05-13
NCT02321176 UNKNOWN
Eye Disease
Huazhong University of Science and Technology
2014-03
NCT01881347 COMPLETED
Diabetes Mellitus
Boston University
2013-01-01
NCT01564381 COMPLETED
Cardiovascular Disease
University of California, Davis
2012-03 PHASE1; PHASE2
NCT01464801 COMPLETED
Fatty Liver
University of Aarhus
2011-09
NCT02062190 COMPLETED
Schizophrenia
Federal University of Rio Grande do Sul
2014-03 PHASE2
NCT01638780 UNKNOWN
Type 2 Diabetes
Maastricht University Medical Center
2012-05
NCT01826279 UNKNOWN
Obesity
University of Aarhus
2013-05
NCT02001831 UNKNOWN
Physical Disability
University College Dublin
2014-01
NCT02137421 COMPLETED
Metabolic Syndrome; Coronary Artery Disease
Tehran University of Medical Sciences
2012-04
NCT01668836 COMPLETED
Vascular System Injuries; Lipid Metabolism Disorders; Endothelial Disfunction
InCor Heart Institute
2012-08
NCT01375959 COMPLETED
Impaired Glucose Tolerance
Albert Einstein College of Medicine
2011-04
NCT01446276 COMPLETED
Obesity; Nonalcoholic Fatty Liver Disease
University of Aarhus
2011-11
NCT01964846 COMPLETED
Effect of Resveratrol and Curcumin on Inflammation
Laval University
2013-10
NCT02409537 COMPLETED
Hypercholesterolemia; Healthy
Aeromedical Center, Thessaloniki
2013-03 PHASE2
NCT01504854 COMPLETED
Alzheimer's Disease
Alzheimer's Disease Cooperative Study (ADCS)
2012-05 PHASE2
NCT02433925 COMPLETED
Chronic Renal Insufficiency
Universidade Federal Fluminense
2013-01 PHASE3
NCT01635114 COMPLETED
Elevated Liver Fat Content and Insulin Resistance
University Hospital Tuebingen
2012-06
NCT02130440 COMPLETED
Seasonal Allergic Rhinitis
University of Campania Luigi Vanvitelli
2012-11 PHASE3
NCT00996229 UNKNOWN
Healthy
University Hospital Muenster
2009-11 PHASE3
NCT01720459 UNKNOWN
Polycystic Ovary Syndrome (PCOS)
Poznan University of Medical Sciences
2012-12
NCT01476592 COMPLETED
Neuroendocrine Tumor
University of Wisconsin, Madison
2011-12
NCT01451918 COMPLETED
Dyslipidaemia; Insulin Resistance
University Health Network, Toronto
2011-10 PHASE2
NCT01412645 COMPLETED
Obesity; Inflammation; Insulin Sensitivity; Osteoporosis
University of Aarhus
2011-08
NCT02114892 COMPLETED
Metabolic Syndrome X
University of Guadalajara
2012-04 PHASE2
NCT01593605 COMPLETED
Impaired Glucose Tolerance
Vanderbilt University
2012-02
NCT01782911 COMPLETED
Androgen Profile; Inflammatory Markers; IVF Outcome
IVI Madrid
2013-02-01
NCT02030977 COMPLETED
Non Alcoholic Fatty Liver
Dr Azita Hekmatdoost
2012-06 PHASE2; PHASE3
NCT01364961 COMPLETED
Dyslipidemia
Maastricht University Medical Center
2011-01
NCT01126229 COMPLETED
Memory
University of Florida
2009-11 PHASE1
NCT01794351 COMPLETED
Cognitive Performance; Mood
Northumbria University
2012-10
NCT01747252 COMPLETED
Healthy
Fruitura Bioscience Ltd.
2012-08
NCT02247596 COMPLETED
Obesity; Diabetes
Khoo Teck Puat Hospital
2009-07 PHASE2
NCT01339884 COMPLETED
Friedreich Ataxia
Murdoch Childrens Research Institute
2011-04 PHASE1; PHASE2
NCT01158417 TERMINATED
Type 2 Diabetes; Obesity; Insulin Resistance
University at Buffalo
2008-12
NCT01370889 COMPLETED
Healthy, no Evidence of Disease
National Cancer Institute (NCI)
2011-06 PHASE1
NCT01321268 TERMINATED
Cellulite (Orange Peel Skin)
dsm-firmenich Switzerland AG
2011-05
NCT01640197 COMPLETED
Healthy
Northumbria University
2011-02 PHASE1
NCT01492114 COMPLETED
Chronic Subclinic Inflammation; Redox Status
University of Turin, Italy
2011-07 PHASE3
NCT01150955 COMPLETED
Metabolic Syndrome; Obesity
University of Aarhus
2010-10
NCT01321151 COMPLETED
Sports Concussion
University of Texas Southwestern Medical Center
2011-03 PHASE1; PHASE2
NCT01324089 COMPLETED
Focus of the Study: Normal Volunteers
University of Wisconsin, Madison
2011-03
NCT01615445 COMPLETED
Sedentary Lifestyle
Ottawa Hospital Research Institute
2009-02 PHASE2
NCT01244360 UNKNOWN
Inflammation
Marywood University
2010-11
NCT01768507 COMPLETED
Healthy Subjects; Heme Oxygenase
Daniel Doberer
2011-03
NCT01173640 COMPLETED
Healthy
University of Washington
2010-07
NCT00678431 COMPLETED
Alzheimer's Disease
US Department of Veterans Affairs
2008-01 PHASE3
NCT00823381 COMPLETED
Obesity; Metabolic Syndrome; Diabetes; Aging
Washington University School of Medicine
2009-01
NCT01038089 COMPLETED
Type 2 Diabetes Mellitus
Boston University
2010-01
NCT01331382 COMPLETED
Healthy
Northumbria University
2010-04
NCT01449110 COMPLETED
Cardiovascular Diseases
National Research Council, Spain
2009-04 PHASE2
NCT01677611 COMPLETED
Type 2 Diabetes
Khoo Teck Puat Hospital
2008-12 PHASE1
NCT00743743 WITHDRAWN
Alzheimer Disease
Medical College of Wisconsin
2008-09 PHASE3
NCT00721877 COMPLETED
Healthy, no Evidence of Disease
National Cancer Institute (NCI)
2008-08 PHASE1
NCT00455416 UNKNOWN
Follicular Lymphoma
Oslo University Hospital
2007-04 PHASE2
NCT01010009 COMPLETED
Cognitive and Cerebral Blood Flow Effects of Resveratrol
Northumbria University
2008-06
NCT00256334 COMPLETED
Colon Cancer; Cancer
University of California, Irvine
2005-07 PHASE1
NCT00433576 COMPLETED
Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum; Stage I Colon Cancer; Stage I Rectal Cancer; Stage II Colon Cancer; Stage II Rectal Cancer; Stage III Colon Cancer; Stage III Rectal Cancer
National Cancer Institute (NCI)
2006-12 PHASE1
NCT00654667 WITHDRAWN
Insulin Resistance
University of California, San Francisco
2007-05 PHASE2
NCT00578396 WITHDRAWN
Colon Cancer
University of California, Irvine
2007-12 PHASE1
NCT03095105 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2006-01-24 PHASE1
NCT03093389 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2005-05-11 PHASE1
NCT03095092 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2005-05-23 PHASE1
NCT03091543 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2004-05-04 PHASE1
NCT00098969 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2004-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-18)

Check the Resveratrol (trans-Resveratrol) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Resveratrol directly engages multiple molecular targets by inhibiting cyclooxygenases (IC50 = 1.1 μM) and lipoxygenases (IC50 = 2.7 μM) while modulating sirtuin activity and intracellular signaling pathways. This target interaction blocks pro-inflammatory mediator cascades and promotes mitophagy, triggering autophagy-dependent apoptosis and metabolic regulation that underpin its therapeutic evaluation in conditions such as type 2 diabetes, peripheral artery disease, and colon cancer.

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.