Coenzyme Q10 has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 to assess its therapeutic utility in cardiovascular dysfunction, non-alcoholic fatty liver disease, sarcopenia, progressive supranuclear palsy, and viral infections. Sponsored by various academic medical centers and research institutes, these protocols exhibit recruitment statuses ranging from completed and actively recruiting to withdrawn or not yet recruiting. Overall, these studies evaluate key endpoints including cardiac parameters, neurodegenerative outcomes, and metabolic dysfunction.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07234422 | RECRUITING | Heart Failure |
Netherlands Heart Institute |
2026-05-04 | PHASE3 |
| NCT07668284 | NOT_YET_RECRUITING | Prostate Cancer; Uterine Cancer; Cervical Cancer; Anal Cancer |
University of Nebraska |
2026-07-01 | PHASE1; PHASE2 |
| NCT06694727 | RECRUITING | Heart Failure |
Tor Biering-Sørensen |
2025-09-30 | PHASE3 |
| NCT06962657 | NOT_YET_RECRUITING | Toxicant Induced Chronic Multisymptom Illness and Associated Symptoms and Comorbidities |
University of California, San Diego |
2026-05-15 | PHASE2 |
| NCT07760506 | NOT_YET_RECRUITING | Healthy Aging; Inflammaging; Metabolic Health; Quercetin; Coenzyme Q10 |
Applied Science & Performance Institute |
2026-08 | |
| NCT06515184 | RECRUITING | Gulf War Syndrome; Persian Gulf Syndrome; Mitochondrial Disorder, Respiratory Chain |
University of California, San Diego |
2024-09-13 | PHASE3 |
| NCT07748130 | NOT_YET_RECRUITING | Mitochondrial Diabetes |
The 95th Hospital of Putian,Putian, Fujian, China |
2026-09 | |
| NCT06597682 | NOT_YET_RECRUITING | Post-acute Sequelae of SARS-COV-2 Infection |
Huashan Hospital |
2025-03 | |
| NCT05422534 | RECRUITING | End Stage Renal Disease |
Vanderbilt University Medical Center |
2023-06-01 | PHASE3 |
| NCT06620523 | RECRUITING | Renal Failure; Coronary Artery Disease; Surgery; Surgery-Complications |
George Washington University |
2024-07-18 | PHASE2 |
| NCT07792005 | NOT_YET_RECRUITING | Cardiovascular Disease (CVD); Elevated Cardiovascular Risk; Endothelial Dysfunction |
Hospital Pengajar Universiti Putra Malaysia |
2026-10 | |
| NCT07476443 | NOT_YET_RECRUITING | Nephrotoxicity |
Ain Shams University |
2026-04-20 | PHASE2; PHASE3 |
| NCT07260773 | NOT_YET_RECRUITING | Ovarian Response |
Tang-Du Hospital |
2026-07 | |
| NCT07677826 | RECRUITING | Depigmentation Treatment; Depigmentation |
Al-Azhar University |
2026-03-02 | |
| NCT07772336 | NOT_YET_RECRUITING | Frailty; Aging; Mitochondria Health; Skin Aging; Mitochondrial Dysfunction |
University Medical Centre Ljubljana |
2026-09 | |
| NCT07502924 | RECRUITING | Muscle Health; Muscle Strength; Body Composition |
Lindenwood University |
2025-03-03 | |
| NCT05942027 | RECRUITING | Chronic Kidney Diseases |
Tanta University |
2023-07-15 | PHASE4 |
| NCT07530250 | COMPLETED | CoQ10 Blood Levels |
Midwest Center for Metabolic and Cardiovascular Research |
2026-05-18 | |
| NCT07252518 | RECRUITING | Asthenozoospermia |
Mst.Sumyara Khatun |
2025-10-01 | |
| NCT07771153 | COMPLETED | Oligospermia |
Mst.Sumyara Khatun |
2025-07-01 | |
| NCT07255079 | COMPLETED | Pharmacokinetic Parameters; Bioavailability Heathy Volunteers |
3i Solutions |
2026-04-03 | |
| NCT07317440 | NOT_YET_RECRUITING | Community Acquired Pneumonia |
Tanta University |
2025-12-31 | |
| NCT07029360 | RECRUITING | Pregnancy; Periodontal Disease; Gingivitis; Dental Plaque; Probiotics; Coenzyme Q10; Microbiota |
University of Pavia |
2025-07-01 | |
| NCT06419335 | ACTIVE_NOT_RECRUITING | Crohn Disease; Healthy |
University of Pennsylvania |
2024-07-20 | EARLY_PHASE1 |
| NCT07331935 | RECRUITING | Oral Leukoplakia |
Alexandria University |
2025-11-25 | |
| NCT06743802 | RECRUITING | Postoperative Pain |
The Second Affiliated Hospital of Chongqing Medical University |
2025-01-09 | PHASE4 |
| NCT07045246 | NOT_YET_RECRUITING | Coenzyme Q10; Alveolar Cleft Grafting |
Fayoum University |
2025-07-15 | |
| NCT06040905 | COMPLETED | Mild Cognitive Impairment; Alzheimer Disease; Hyperglycemia; Pre-sarcopenia |
Chung Shan Medical University |
2024-01-24 | |
| NCT07307911 | COMPLETED | Breast Cancer |
Damanhour University |
2025-11-10 | PHASE2 |
| NCT07455890 | COMPLETED | Asthenozoospermia |
Mst.Sumyara Khatun |
2024-07-01 | |
| NCT04444349 | RECRUITING | Cardiovascular Disease |
Nanjing Medical University |
2021-02-01 | |
| NCT04972552 | ACTIVE_NOT_RECRUITING | Kidney Transplantation |
University of California, San Francisco |
2021-11-15 | |
| NCT06361680 | UNKNOWN | Type 1 Diabetes Mellitus |
Assiut University |
2024-10-30 | EARLY_PHASE1 |
| NCT06308497 | ENROLLING_BY_INVITATION | Periodontal Diseases; Pregnancy Related |
University of Pavia |
2024-03-10 | |
| NCT06640465 | COMPLETED | Wellness; Health |
OvationLab |
2024-10-12 | PHASE2; PHASE3 |
| NCT06089395 | UNKNOWN | Poor Ovarian Response |
Shi Yun |
2024-06-01 | EARLY_PHASE1 |
| NCT06619249 | UNKNOWN | Health Knowledge, Attitudes, Practice |
Gdansk University of Physical Education and Sport |
2024-08-23 | PHASE4 |
| NCT05984745 | RECRUITING | Fatty Liver; NAFLD |
Ain Shams University |
2023-10-31 | PHASE2 |
| NCT06856447 | RECRUITING | Colorectal Cancer |
toqa saad mohammed mohammed |
2024-06-01 | PHASE1 |
| NCT06659406 | UNKNOWN | Polycystic Ovarian Syndrome (PCOS) |
University of Faisalabad |
2025-01-01 | |
| NCT06570811 | COMPLETED | Breast Cancer; Chemotherapeutic Toxicity |
Damanhour University |
2024-08-01 | PHASE2 |
| NCT05873673 | ACTIVE_NOT_RECRUITING | Cyst, Jaw |
Fayoum University |
2023-06-11 | PHASE2 |
| NCT06506630 | UNKNOWN | Metabolic Syndrome; Cardiovascular Diseases |
Tian Zezhong |
2023-09-11 | |
| NCT06405204 | UNKNOWN | IVF |
Beni-Suef University |
2024-06-30 | PHASE3 |
| NCT06736366 | COMPLETED | Coenzyme Q Deficiency |
University of Primorska |
2024-12-05 | |
| NCT07303088 | COMPLETED | Oxidative Stress Response; Hemodialysis; End Stage Kidney Disease (ESRD) |
University of Sfax |
2024-06-17 | |
| NCT07096557 | COMPLETED | Systemic Lupus Erythematosus |
Ain Shams University |
2024-01-01 | PHASE2 |
| NCT05500742 | UNKNOWN | Aging |
IRCCS Azienda Ospedaliero-Universitaria di Bologna |
2022-07-22 | |
| NCT06429345 | UNKNOWN | Contrast-induced Nephropathy |
Ain Shams University |
2024-06-15 | PHASE4 |
| NCT06452134 | UNKNOWN | Molar, Third; Temporomandibular Joint Disorders; Dry Socket; Coenzyme Q10 |
Zahra Nejati |
2024-07 | PHASE4 |
| NCT05945160 | WITHDRAWN | Vestibular Function Disorder |
The University of Texas Health Science Center at San Antonio |
2024-01 | EARLY_PHASE1 |
| NCT06342856 | UNKNOWN | Infertility Unexplained; Oligospermia |
Ain Shams University |
2023-06-15 | EARLY_PHASE1 |
| NCT03831425 | WITHDRAWN | Prader-Willi Syndrome |
The Hospital for Sick Children |
2023-06-01 | PHASE2 |
| NCT06373848 | ENROLLING_BY_INVITATION | Periodontal Diseases |
Islamic Azad University, Sanandaj |
2024-03-20 | |
| NCT06661018 | COMPLETED | ST Segment Elevation Myocardial Infarction (STEMI); Coenzyme Q10 |
Universitas Diponegoro |
2024-01-28 | |
| NCT06358963 | UNKNOWN | Periodontal Diseases |
Amirhossein Farahmand |
2024-02-20 | |
| NCT04286178 | COMPLETED | Myositis, Juvenile |
The Hospital for Sick Children |
2021-04-06 | |
| NCT05731596 | UNKNOWN | Nonalcoholic Steatohepatitis |
Tanta University |
2023-06 | PHASE3 |
| NCT05471453 | COMPLETED | Dietary Supplements |
Kaohsiung Veterans General Hospital. |
2022-03-02 | |
| NCT05653895 | COMPLETED | PCOS |
Khyber Medical University Peshawar |
2022-12-07 | |
| NCT04999488 | Withdrawn | Sarcopenia |
AdventHealth Translational Research Institute |
2023-12 | Early Phase 1 |
| NCT05871086 | UNKNOWN | Juvenile Idiopathic Arthritis |
Nourhan Elsherif |
2023-05-01 | PHASE2; PHASE3 |
| NCT07537283 | COMPLETED | Epilepsy; Drugs Resistance |
National Cheng-Kung University Hospital |
2023-02-07 | |
| NCT05984745 | Not yet recruiting | Fatty Liver|NAFLD |
Ain Shams University |
2023-09 | Phase 2 |
| NCT05941910 | UNKNOWN | Non-Alcoholic Fatty Liver Disease |
Attikon Hospital |
2023-04-01 | PHASE2 |
| NCT05412888 | NOT_YET_RECRUITING | Ischemic Preconditioning; Coenzyme Q Deficiency; Exercise Training |
Medical University of Gdansk |
2023-03-01 | |
| NCT05680857 | COMPLETED | Healthy |
USMARI Research & Innovation Centre |
2022-12-01 | |
| NCT05293132 | COMPLETED | Sepsis |
Ain Shams University |
2022-02-01 | PHASE2; PHASE3 |
| NCT05711810 | COMPLETED | Severe Acute Respiratory Syndrome-related Coronavirus; Renal Dialysis; Vaccines; Myocarditis Allergic; Infection Viral |
Yang I. Pachankis |
2023-01-02 | PHASE4 |
| NCT03113994 | TERMINATED | Spinal Cord Injuries; Osteoporosis; Metabolic Syndrome |
Dr. B. Catharine. Craven |
2018-02-26 | PHASE2 |
| NCT05616000 | COMPLETED | Infertility |
Khyber Medical University Peshawar |
2022-08-06 | PHASE2 |
| NCT06151171 | COMPLETED | Coenzyme Q10 Pharmacokinetics |
Factors Group of Nutritional Companies Inc. |
2022-03-01 | |
| NCT05847257 | COMPLETED | Male Reproductive Problem; Infertility, Male |
Al-Mustansiriyah University |
2021-12-01 | PHASE2 |
| NCT04487652 | COMPLETED | Gingival Recession |
University of Bern |
2020-09-01 | |
| NCT05170893 | COMPLETED | Hemodialysis |
Ain Shams University |
2022-01-17 | |
| NCT05272228 | COMPLETED | Coenzyme Q Deficiency |
University of Primorska |
2022-03-09 | |
| NCT03611530 | TERMINATED | Open Angle Glaucoma |
Mario Negri Institute for Pharmacological Research |
2017-09-04 | |
| NCT04960215 | COMPLETED | Covid19; Long Term Covid19 |
Aarhus University Hospital |
2021-05-25 | PHASE2 |
| NCT04091698 | UNKNOWN | Oral Lichen Planus |
Cairo University |
2019-10-01 | PHASE1 |
| NCT04445779 | UNKNOWN | Acute Kidney Injury; Acute Kidney Failure |
Clinical Hospital Center, Split |
2020-07-15 | |
| NCT04038034 | UNKNOWN | Glaucoma, Open-Angle |
VISUfarma SpA |
2019-09-01 | |
| NCT05178225 | COMPLETED | COVID-19 Respiratory Infection |
Comenius University |
2021-05-01 | |
| NCT04780074 | COMPLETED | Bioavailability of Coenzyme Q10 |
Institute of Nutrition, Slovenia (Nutris) |
2021-02-28 | |
| NCT03579693 | COMPLETED | Chronic Kidney Disease; Sarcopenia; Frailty |
University of Washington |
2018-11-14 | PHASE2 |
| NCT03133793 | COMPLETED | Heart Failure, Diastolic |
University of Kansas Medical Center |
2018-02-05 | PHASE2 |
| NCT02865460 | COMPLETED | Gulf War Illness; Chronic Fatigue; Ubiquinol; Coenzyme Q10 |
VA Office of Research and Development |
2017-07-24 | PHASE3 |
| NCT04302532 | COMPLETED | Coenzyme q10 |
Karachi Medical and Dental College |
2020-07-01 | PHASE4 |
| NCT04035525 | UNKNOWN | Healthy |
Mélanie Plourde |
2020-03-04 | |
| NCT03968640 | WITHDRAWN | Multiple Organ Failure |
American Burn Association |
2018-07-01 | PHASE3 |
| NCT03186027 | COMPLETED | Chronic Fatigue Syndrome |
Hospital Universitari Vall d'Hebron Research Institute |
2017-06-28 | |
| NCT03961087 | UNKNOWN | Hepatic Encephalopathy; Coenzyme Q10; Intellectual Functioning Disability |
Zagazig University |
2019-05-23 | |
| NCT03190044 | UNKNOWN | Migraine Disorders |
University of Roma La Sapienza |
2017-06-06 | |
| NCT03576911 | UNKNOWN | Schizophrenia; Schizoaffective Disorder |
University of Dublin, Trinity College |
2016-11 | |
| NCT03321110 | COMPLETED | Athlete |
Chung Shan Medical University |
2017-12-01 | |
| NCT06391606 | COMPLETED | Hypercholesterolemia; Physical Performance |
University of Bologna |
2018-10-01 | |
| NCT03811756 | COMPLETED | Dermis Density; Trans Epidermal Water Loss (TEWL); Skin Hydration; Wrinkles; Dermis Thickness |
VIST - Faculty of Applied Sciences |
2018-10-15 | |
| NCT03850561 | COMPLETED | Male Infertility |
University of Sumer |
2018-06-01 | |
| NCT03834831 | COMPLETED | Male Infertility |
University of Sumer |
2018-06-01 | |
| NCT05128292 | COMPLETED | Myalgic Encephalomyelitis |
Hospital Universitari Vall d'Hebron Research Institute |
2018-01-01 | |
| NCT03819491 | COMPLETED | Male & Female Healthy Volunteers |
VISUfarma SpA |
2018-06-22 | PHASE1 |
| NCT03213769 | UNKNOWN | Oral Aphthous Ulcer |
Cairo University |
2017-07 | |
| NCT03893864 | COMPLETED | Coenzyme Q10; Oxidative Stress; Aging |
Centre d'Alt Rendiment |
2018-03-01 | PHASE1 |
| NCT02119117 | COMPLETED | Mitochondrial DNA; Aneuploidy |
Reproductive Endocrinology Associates of Charlotte |
2014-04 | |
| NCT03104998 | WITHDRAWN | Idiopathic Infertility |
PharmEvo Pvt Ltd |
2017-08-01 | PHASE4 |
| NCT03111433 | COMPLETED | Diabetes Mellitus, Type 1 |
Ain Shams University |
2017-03-19 | PHASE2 |
| NCT03020680 | COMPLETED | Absorption |
Tufts University |
2016-04-01 | PHASE1 |
| NCT01126697 | COMPLETED | Duchenne Muscular Dystrophy; Becker Muscular Dystrophy; Limb Girdle Muscular Dystrophy |
Cooperative International Neuromuscular Research Group |
2010-02 | PHASE2; PHASE3 |
| NCT02010164 | UNKNOWN | Reproductive Physiological Phenomena |
Hadassah Medical Organization |
2016-12 | |
| NCT03284814 | COMPLETED | Bioavailability of Coenzyme Q10 |
Institute of Nutrition, Slovenia (Nutris) |
2017-08-29 | |
| NCT02333305 | COMPLETED | Ataxia-oculomotor Apraxia 1 |
Assistance Publique - Hôpitaux de Paris |
2013-06 | PHASE3 |
| NCT02407548 | COMPLETED | Dyslipidemia |
Sun Yat-sen University |
2015-07 | PHASE3 |
| NCT02251626 | UNKNOWN | Burn Injury |
Massachusetts General Hospital |
2014-04 | EARLY_PHASE1 |
| NCT02486796 | TERMINATED | Quality of Life |
Midwestern Regional Medical Center |
2016-02-19 | PHASE1; PHASE2 |
| NCT02622672 | COMPLETED | Diabetes |
Yeh |
2016-01-04 | PHASE2; PHASE3 |
| NCT02218476 | UNKNOWN | Coenzyme Q10 on Athero-thrombosis in APS Patients |
Maimónides Biomedical Research Institute of Córdoba |
2013-09 | |
| NCT03074344 | COMPLETED | Dry Eye Syndrome |
Azienda Ospedaliera Universitaria Policlinico "G. Martino" |
2016-05 | |
| NCT02353650 | UNKNOWN | Tinnitus |
University Hospital, Antwerp |
2014-11 | |
| NCT01032993 | COMPLETED | Pain; Weakness; Cramps; Myalgia or Myositis Nos; HMG COA Reductase Inhibitor Adverse Reaction |
Catherine Buettner |
2009-12 | PHASE2; PHASE3 |
| NCT01964001 | COMPLETED | Hepatocellular Carcinoma. |
Taichung Veterans General Hospital |
2014-01 | PHASE2; PHASE3 |
| NCT02042482 | UNKNOWN | Myelodysplastic Syndrome |
Kaplan Medical Center |
2013-05 | PHASE2; PHASE3 |
| NCT02315651 | UNKNOWN | Attention Deficit Hyperactivity Disorder |
Rabin Medical Center |
2015-01 | |
| NCT02415114 | COMPLETED | CoQ10 Blood Levels; CoQ10 Blood Levels With Statin Use |
KGK Science Inc. |
2015-03 | PHASE1 |
| NCT02604641 | COMPLETED | Wrinkles; Ageing; Photoprotection |
VIST - Faculty of Applied Sciences |
2014-10 | |
| NCT00608881 | TERMINATED | Huntington's Disease |
Massachusetts General Hospital |
2008-03 | PHASE3 |
| NCT01659788 | UNKNOWN | Ovarian Function at Advanced Reproductive Age |
Hadassah Medical Organization |
2012-09 | |
| NCT00997269 | COMPLETED | Pain; Soreness; Weakness; Fatigue |
Stony Brook University |
2009-09 | |
| NCT01948063 | COMPLETED | Sepsis |
Beth Israel Deaconess Medical Center |
2012-10 | PHASE2 |
| NCT01819701 | COMPLETED | Coronary Artery Disease |
Taichung Veterans General Hospital |
2013-01 | PHASE2; PHASE3 |
| NCT01925937 | UNKNOWN | Congestive Heart Failure |
Isfahan University of Medical Sciences |
2013-06 | |
| NCT01148836 | COMPLETED | Pulmonary Arterial Hypertension |
The Cleveland Clinic |
2010-01 | |
| NCT01408680 | COMPLETED | Oxidative Stress; Inflammation; Endothelial Dysfunction |
University of Washington |
2011-11 | |
| NCT01140308 | UNKNOWN | Statin Myopathy |
Hartford Hospital |
2009-09 | |
| NCT00382824 | COMPLETED | Progressive Supranuclear Palsy |
Lahey Clinic |
2006-09 | |
| NCT01660191 | COMPLETED | Hypercholesterolemia |
University of Kansas Medical Center |
2011-12 | PHASE4 |
| NCT00432744 | COMPLETED | Mitochondrial Diseases |
University of Florida |
2007-01 | PHASE3 |
| NCT01424761 | COMPLETED | Coronary Artery Disease |
Taichung Veterans General Hospital |
2011-08 | PHASE2; PHASE3 |
| NCT02381964 | COMPLETED | Metabolic Processes |
Northumbria University |
2012-03 | |
| NCT01910766 | COMPLETED | Polycystic Ovary Syndrome |
Mansoura University |
2010-01 | |
| NCT02063126 | COMPLETED | Chronic Fatigue Syndrome |
Hospital Universitari Vall d'Hebron Research Institute |
2013-01 | PHASE2; PHASE3 |
| NCT00541164 | COMPLETED | Charcot Marie Tooth Disease |
Memorial Medical Center |
2007-09 | PHASE1; PHASE2 |
| NCT01048385 | TERMINATED | Aneuploidy; Pregnancy; Miscarriage |
University of Toronto |
2009-12 | |
| NCT01892176 | COMPLETED | Parkinson Disease |
National University Hospital, Singapore |
2012-06 | PHASE2; PHASE3 |
| NCT00891917 | WITHDRAWN | Down Syndrome |
Children's Hospital Medical Center, Cincinnati |
2005-01 | PHASE2 |
| NCT00976131 | COMPLETED | Breast Cancer |
Columbia University |
2009-09 | PHASE1 |
| NCT00716612 | COMPLETED | Statin Induced Myalgia |
Hadassah Medical Organization |
2009-01 | |
| NCT01390389 | COMPLETED | Bipolar Depression |
Mclean Hospital |
2011-07 | |
| NCT00920699 | COMPLETED | Huntington's Disease |
Johns Hopkins University |
2010-02 | PHASE2 |
| NCT01319110 | COMPLETED | Cardiac Arrest; Sudden Cardiac Arrest |
Beth Israel Deaconess Medical Center |
2011-02 | PHASE2 |
| NCT00893724 | UNKNOWN | Neovascular Age-related Macular Degeneration; Diabetic Macular Edema |
Mid-Atlantic Retina Consultations, Inc. |
2009-06 | |
| NCT00740714 | TERMINATED | Parkinson Disease |
Weill Medical College of Cornell University |
2008-12 | PHASE3 |
| NCT01011348 | COMPLETED | Gulf War Illness |
University of California, San Diego |
2008-07 | |
| NCT01026311 | COMPLETED | Muscle Weakness; Myalgia; Side Effects of Statins |
Richard Deichmann, MD |
2009-11 | PHASE4 |
| NCT00308113 | TERMINATED | Duchenne Muscular Dystrophy |
Cooperative International Neuromuscular Research Group |
2007-04 | PHASE3 |
| NCT00908297 | COMPLETED | Cardiovascular Disease; End Stage Renal Disease; Atherosclerosis; Oxidative Stress |
University of Washington |
2010-02 | |
| NCT00860847 | COMPLETED | Coronary Atherosclerosis; Coronary Artery Calcification; Coronary Stenosis |
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center |
2009-05 | PHASE3 |
| NCT00720369 | COMPLETED | Bipolar Depression |
Mclean Hospital |
2008-07 | |
| NCT01443780 | COMPLETED | Cardiovascular Mortality; Cardiac Function |
University Hospital, Linkoeping |
2003-01 | |
| NCT00718796 | COMPLETED | Cardiovascular Disease |
The Canadian College of Naturopathic Medicine |
2008-04 | PHASE3 |
| NCT00096356 | COMPLETED | Breast Cancer; Fatigue |
Wake Forest University Health Sciences |
2004-08-27 | PHASE1 |
| NCT00957216 | COMPLETED | Sporadic Ataxia |
The University of Texas Medical Branch, Galveston |
2008-04 | PHASE1 |
| NCT02012322 | COMPLETED | Age Related Symptoms; Age Related Quality of Life Issues |
University of California, San Diego |
2008-11 | |
| NCT00327756 | WITHDRAWN | Bipolar Affective Disorder; Depression |
National Institute of Mental Health (NIMH) |
2006-05 | PHASE2 |
| NCT01163500 | COMPLETED | Coronary Artery Disease |
Taichung Veterans General Hospital |
2008-07 | PHASE2; PHASE3 |
| NCT00590408 | TERMINATED | Statin-associated Myalgia |
Creighton University |
2006-03 | PHASE4 |
| NCT02115581 | COMPLETED | Dilated Cardiomyopathy |
University of Tehran |
2006-09 | PHASE4 |
| NCT00243932 | COMPLETED | Amyotrophic Lateral Sclerosis; Lou Gehrig's Disease |
Columbia University |
2005-04 | PHASE2 |
| NCT00076492 | COMPLETED | Parkinson Disease |
University of Rochester |
2004-01 | PHASE2 |
| NCT00180037 | COMPLETED | Parkinson's Disease |
Technische Universität Dresden |
2003-09 | PHASE3 |
| NCT00703482 | COMPLETED | Patients With Type 2 Diabetes |
Solvay Pharmaceuticals |
2003-05 | PHASE2 |
| NCT00328874 | COMPLETED | Progressive Supranuclear Palsy |
German Parkinson Study Group (GPS) |
2006-05 | PHASE2 |
| NCT00307996 | COMPLETED | Chronic Renal Failure; Hemodialysis |
University of Shizuoka |
2004-03 | PHASE4 |
| NCT00247026 | WITHDRAWN | Myelodysplastic Syndrome |
Hadassah Medical Organization |
2007-04 | PHASE1; PHASE2 |
| NCT00532571 | COMPLETED | Progressive Supranuclear Palsy; Neurological Disorders |
Lahey Clinic |
2004-01 | PHASE2; PHASE3 |
| NCT00878124 | TERMINATED | Poor Ovarian Response |
University of Toronto |
2009-06 | |
| NCT00300937 | COMPLETED | Preeclampsia |
Teran, Enrique, MD, PhD |
2004-07 | PHASE3 |
| NCT00033189 | COMPLETED | Muscular Dystrophy, Duchenne |
Cooperative International Neuromuscular Research Group |
2001-09 | PHASE2 |
| NCT00004731 | COMPLETED | Parkinson's Disease |
National Institute of Neurological Disorders and Stroke (NINDS) |
1998-09 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-05-19)
Mechanism and Biochemical Profile
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>).