Numerous clinical trials spanning Phase 1 through Phase 4, alongside observational studies, evaluate Vitamin B12 across a wide spectrum of indications, including deficiency, gestational diabetes, generalized anxiety disorder, postoperative cognitive dysfunction, and chronic hepatitis C infection. Sponsored primarily by global academic and medical research institutions, these active and historic studies encompass various recruitment statuses—from recruiting to completed or terminated—and examine targeted areas such as maternal nutritional intake and post-surgical cognitive outcomes.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06966856 | NOT_YET_RECRUITING | Hypovitaminosis b 12 |
Tanta University |
2026-12-30 | PHASE3 |
| NCT04150042 | RECRUITING | Pancreatic Adenocarcinoma Metastatic; BRCA1 Mutation; BRCA2 Mutation; Pancreatic Acinar Cell Carcinoma; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Metastatic Pancreatic Cancer; Metastatic Pancreatic Ductal Adenocarcinoma; Breast Cancer Metastatic; Breast Cancer Stage IV; Pancreatic Cancer Stage IV; HER2-negative Breast Cancer; HER2 Negative Breast Carcinoma; Adenocarcinoma of the Breast; PALB2 Gene Mutation; Pancreas Cancer, Metastatic; Pancreas Cancer, Recurrent; Pancreas Cancer; Stage IV Pancreatic Cancer; Stage 4 Pancreatic Cancer |
General Oncology, Inc. |
2021-01-13 | PHASE1 |
| NCT07697196 | NOT_YET_RECRUITING | HPV Infection; HPV Integration; HPV Disease; HPV Genital Infection; HPV Persistence; Low Grade Squamous Intraepithelial Lesions of the Cervix |
IRCCS San Raffaele |
2026-07 | |
| NCT07344337 | NOT_YET_RECRUITING | HPV Infection; Infertilities |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
2026-03 | |
| NCT07320183 | NOT_YET_RECRUITING | HPV - Anogenital Human Papilloma Virus Infection; Infertilities |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
2026-03-01 | |
| NCT05796401 | RECRUITING | Psychosis |
Centre Hospitalier St Anne |
2023-12-15 | PHASE3 |
| NCT07665671 | RECRUITING | Healthy Volunteers |
RDC Clinical Pty Ltd |
2026-07-20 | PHASE4 |
| NCT07443410 | RECRUITING | Periodontitis, Adult; Periodontitis (Stage 3); Periodontitis Stage IV |
University Hospital Heidelberg |
2024-10-25 | |
| NCT07781020 | COMPLETED | Vitamin B12 Deficiency; Renal Failure , Chronic; Renal Dialysis |
Jinnah Hospital |
2026-02-22 | |
| NCT07341789 | ENROLLING_BY_INVITATION | Vitamin b12; Supplementation During Endurance Performance; Flavonoids; Mental Fatigue; Biomarker Feedback |
Francisco Javier Martínez Noguera |
2025-12-01 | |
| NCT07486141 | ACTIVE_NOT_RECRUITING | Mild Cognitive Impairment |
Capital Medical University |
2024-11-01 | |
| NCT06654154 | RECRUITING | Level of Serum Vitamin B12 Level (in Pmol/L) If Relapse of (AI/ID) Under Tocilizumab; Level of Serum Vitamin B12 Level (in Pmol/L) If Infection Under Tocilizumab |
University Hospital, Clermont-Ferrand |
2024-04-03 | |
| NCT06285357 | RECRUITING | HPV Infection |
Lo.Li.Pharma s.r.l |
2024-02-19 | |
| NCT06749756 | RECRUITING | Septic Shock |
Fan Zeng |
2025-02-10 | |
| NCT07004465 | COMPLETED | Mouth Ulcer |
Hawraa Ali Abdullah |
2025-08-19 | |
| NCT07793838 | COMPLETED | Polycystic Ovary Syndrome (PCOS) Women |
Jerash Private University |
2025-08-01 | PHASE4 |
| NCT07048860 | RECRUITING | Ageing |
University Hospital, Toulouse |
2025-07-09 | |
| NCT06772220 | RECRUITING | Parkinson&Amp;#39;s Disease |
Oregon Health and Science University |
2024-03-05 | |
| NCT05751187 | ACTIVE_NOT_RECRUITING | Non-squamous NSCLC |
Shanghai Chest Hospital |
2023-06-27 | PHASE2 |
| NCT06983223 | COMPLETED | Vitamin B 12 Deficiency; Type 2 Diabetes Mellitus (T2DM) |
Liaquat University of Medical & Health Sciences |
2025-08-15 | |
| NCT05005897 | RECRUITING | Vitamin B 12 Deficiency |
Sykehuset Innlandet HF |
2021-12-08 | PHASE2; PHASE3 |
| NCT07029698 | COMPLETED | Vitamin B12 Deficiency |
Medice Arzneimittel Pütter GmbH & Co KG |
2025-04-16 | PHASE4 |
| NCT05785585 | RECRUITING | Vitamin B12 Nutritional Deficiency |
Fundació Eurecat |
2023-09-09 | |
| NCT05385042 | COMPLETED | Pregnancy Related |
University of Oxford |
2022-06-18 | |
| NCT04456985 | UNKNOWN | Delirium |
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
2020-06-01 | |
| NCT05740462 | UNKNOWN | Iron Deficiency (Without Anemia); B12 Deficiency Vitamin |
Quadram Institute Bioscience |
2023-05-04 | |
| NCT06632470 | NOT_YET_RECRUITING | Dementia; Moderate Dementia |
Baermed |
2024-10-15 | PHASE1 |
| NCT06443593 | UNKNOWN | Type 1 Diabetes |
Hirabai Cowasji Jehangir Medical Research Institute |
2024-02-08 | |
| NCT07022938 | COMPLETED | Cancer; Neuropathy; Chemotherapy Induced Pain Neuropathy; Chemotherapy-Induced Peripheral Neuropathy |
Aristotle University Of Thessaloniki |
2021-11-01 | PHASE4 |
| NCT06186154 | UNKNOWN | Mitochondrial DNA Deletion; Macrocytosis |
University of British Columbia |
2024-01 | PHASE1 |
| NCT06046703 | Not yet recruiting | Vitamin B 12 Deficiency|Pregnancy|Nutrient Deficiency|Dietary Exposure |
Maastricht University Medical Center |
2025-01-01 | -- |
| NCT04205786 | WITHDRAWN | HR-positive Breast Cancer |
Case Comprehensive Cancer Center |
2021-08-12 | |
| NCT05423028 | UNKNOWN | Carpal Tunnel Syndrome |
National Cheng-Kung University Hospital |
2021-12-07 | |
| NCT03853304 | UNKNOWN | Anemia; Folate Deficiency; Vitamin B 12 Deficiency |
Cornell University |
2023-10-01 | |
| NCT06639789 | RECRUITING | Performance Enhancing Product Use |
Francisco Javier Martínez Noguera |
2024-07-01 | |
| NCT04343170 | COMPLETED | Ultra-short-term; Iron Deficiency Anemia; Scoliosis Idiopathic |
Tanta University |
2023-09-01 | |
| NCT06100146 | COMPLETED | Folate Deficiency; Vitamin B 12 Deficiency; Anemia, Megaloblastic; Cognitive Development; Depressive Symptoms |
University Ghent |
2023-12-11 | |
| NCT06376591 | COMPLETED | Vitamin B 12 Deficiency |
Liaquat University of Medical & Health Sciences |
2024-04-12 | |
| NCT04310059 | Not yet recruiting | Thalassemia|Folic Acid Deficiency Anemia |
The University of Hong Kong|Queen Mary Hospital Hong Kong |
2024-07-01 | Not Applicable |
| NCT06098456 | COMPLETED | Papilloma-induced Cervical Lesions |
Centro di Ricerca Clinica Salentino |
2023-11-01 | PHASE2 |
| NCT06218030 | Not yet recruiting | Generalized Anxiety Disorder |
Queen''s University |
2024-04 | Phase 4 |
| NCT05426395 | ACTIVE_NOT_RECRUITING | Vitamin B 12 Deficiency |
George Washington University |
2023-06-05 | PHASE1 |
| NCT04786964 | TERMINATED | Metastatic Non-squamous Non Small Cell Lung Cancer |
Checkpoint Therapeutics, Inc. |
2021-12-08 | PHASE3 |
| NCT06096298 | UNKNOWN | Vitamin B12 Absorption |
University of Helsinki |
2023-10 | |
| NCT05931965 | COMPLETED | Depression |
Riphah International University |
2022-10-05 | |
| NCT06241638 | COMPLETED | Diabetes Mellitus |
Al-Balqa Applied University |
2022-07-01 | |
| NCT05614960 | COMPLETED | Vitamin B 12 Deficiency |
Fu Jen Catholic University |
2022-11-07 | |
| NCT05289908 | COMPLETED | Leptomeningeal Metastases |
The First Hospital of Jilin University |
2022-02-21 | PHASE1; PHASE2 |
| NCT03783091 | COMPLETED | Septic Shock |
Medical College of Wisconsin |
2019-08-05 | PHASE2 |
| NCT05958277 | COMPLETED | Traumatic Brain Injury |
KRL Hospital, Islamabad |
2021-06-01 | PHASE3 |
| NCT05625308 | COMPLETED | Papilloma; Cervix Lesion |
Lo.Li.Pharma s.r.l |
2022-07-01 | |
| NCT05097365 | ENROLLING_BY_INVITATION | Overweight and Obesity; Lupus Erythematosus |
University of Sao Paulo |
2022-01-01 | |
| NCT05260593 | UNKNOWN | Carpal Tunnel Syndrome |
October 6 University |
2022-03-16 | |
| NCT03071666 | ACTIVE_NOT_RECRUITING | Pregnancy Related; Vitamin B 12 Deficiency; Anemia |
Centre For International Health |
2017-03-27 | PHASE2; PHASE3 |
| NCT03735316 | TERMINATED | Vasoplegic Syndrome |
Mayo Clinic |
2019-04-25 | PHASE2 |
| NCT04265534 | TERMINATED | Non-Small Cell Lung Cancer; Non-squamous Non-small-cell Lung Cancer; Non-Squamous Non-Small Cell Neoplasm of Lung; KEAP1 Gene Mutation; NRF2 Gene Mutation; NFE2L2 Gene Mutation |
Calithera Biosciences, Inc |
2020-07-24 | PHASE2 |
| NCT03626922 | UNKNOWN | Metastatic Colorectal Cancer |
NSABP Foundation Inc |
2019-05-15 | PHASE1 |
| NCT03258385 | COMPLETED | Early Pregnancy |
International Centre for Diarrhoeal Disease Research, Bangladesh |
2017-09-01 | |
| NCT04395768 | UNKNOWN | COVID19 |
National Institute of Integrative Medicine, Australia |
2020-09-09 | PHASE2 |
| NCT03485404 | TERMINATED | Post Operative Cognitive Dysfunction |
Xijing Hospital |
2019-01-10 | |
| NCT04627181 | UNKNOWN | Iron Deficiency Anemia; B12 Deficiency Anemia |
Christian Medical College, Vellore, India |
2020-11-18 | PHASE4 |
| NCT04235426 | UNKNOWN | Carpal Tunnel |
Dalia Salah Saif |
2018-01-26 | PHASE1 |
| NCT04404751 | COMPLETED | Anemia |
Haydom Lutheran Hospital |
2019-08-23 | |
| NCT03887169 | COMPLETED | Pulmonary Alveolar Proteinosis; Mutation Ala393Thr of the MARS Gene; mutationSer567Leu of the MARS Gene |
Assistance Publique - Hôpitaux de Paris |
2019-09-16 | PHASE1; PHASE2 |
| NCT04355949 | COMPLETED | Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation |
Sohag University |
2020-02-28 | |
| NCT03802422 | WITHDRAWN | Carpal Tunnel Syndrome |
Tri-Service General Hospital (TSGH) |
2019-04-20 | |
| NCT04706377 | COMPLETED | Diabetes Mellitus; Diabetic Neuropathies; Diabetic Complication; Diabetic Foot |
Aristotle University Of Thessaloniki |
2018-02-01 | |
| NCT03778008 | UNKNOWN | Stomatitis |
Second Affiliated Hospital of Nanchang University |
2018-12-21 | PHASE2 |
| NCT03193788 | UNKNOWN | Bladder Cancer; Ureter Cancer; Transitional Cell Carcinoma |
Asan Medical Center |
2017-01 | PHASE3 |
| NCT05993962 | COMPLETED | Vitamin B 12 Deficiency |
University of British Columbia |
2019-01-10 | |
| NCT04085354 | COMPLETED | Premature Ejaculation |
Sohag University |
2019-02-10 | PHASE3 |
| NCT03950674 | COMPLETED | Non-Small-Cell Lung Carcinoma |
Merck Sharp & Dohme LLC |
2016-02-22 | PHASE3 |
| NCT03384862 | COMPLETED | Arsenic Exposure |
Columbia University |
2018-01-27 | |
| NCT03437824 | COMPLETED | Vitamin B 12 Deficiency |
University of Southern California |
2017-10-01 | EARLY_PHASE1 |
| NCT03864198 | UNKNOWN | Male Infertility |
University Of Perugia |
2019-01-20 | |
| NCT03593304 | COMPLETED | Vincristine Induced Neurotoxicity; Acute Lymphoblastic Leukaemia |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
2018-03-29 | PHASE2; PHASE3 |
| NCT01500785 | TERMINATED | Myocardial Stunning |
Tampere University Hospital |
2018-06-15 | PHASE4 |
| NCT03372447 | COMPLETED | Megaloblastic Anemia Nos; Pernicious Anemia |
Hospital Universitario Dr. Jose E. Gonzalez |
2017-12-27 | PHASE4 |
| NCT03825042 | COMPLETED | Cognitive Dysfunction |
A. Menarini Industrie Farmaceutiche Riunite S.r.l. |
2018-01-23 | |
| NCT04027959 | COMPLETED | Macrocytic Anemia With Vitamin B12 Deficiency |
James J. Peters Veterans Affairs Medical Center |
2017-10-05 | |
| NCT02106650 | COMPLETED | Relapsed Peripheral T-Cell Lymphoma; Refractory Peripheral T-Cell Lymphoma |
Acrotech Biopharma Inc. |
2014-07 | PHASE2 |
| NCT03101579 | COMPLETED | Leptomeningeal Metastases |
The First Hospital of Jilin University |
2017-03-01 | PHASE1 |
| NCT02916121 | UNKNOWN | Schizophrenia |
Taipei Medical University WanFang Hospital |
2016-10 | |
| NCT02923388 | COMPLETED | Vincristine Induced Peripheral Neuropathy (VIPN) |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
2016-10 | PHASE4 |
| NCT02272842 | UNKNOWN | Development; Vitamin Deficiency; Malnutrition |
Centre For International Health |
2015-04-20 | PHASE2; PHASE3 |
| NCT02031289 | COMPLETED | Anemia; Iron Deficiency |
University of Zurich |
2013-12 | PHASE4 |
| NCT01476007 | COMPLETED | Vitamin B 12 Deficiency |
Gerencia de Atención Primaria, Madrid |
2014-07 | |
| NCT02578680 | COMPLETED | Non-Small-Cell Lung Carcinoma |
Merck Sharp & Dohme LLC |
2016-01-15 | PHASE3 |
| NCT02795572 | TERMINATED | Peripheral Neuropathy in Breast Cancer Patient |
AHS Cancer Control Alberta |
2017-06-27 | PHASE2 |
| NCT02786823 | COMPLETED | Diabetes Mellitus, Type 2 |
All India Institute of Medical Sciences, Bhubaneswar |
2017-05-01 | PHASE2; PHASE3 |
| NCT03349333 | COMPLETED | Refractory Peripheral T-Cell Lymphoma; Relapsed T-Cell Lymphoma |
Mundipharma (China) Pharmaceutical Co. Ltd |
2015-09-10 | PHASE3 |
| NCT03408639 | COMPLETED | Anemia in End-Stage Renal Disease |
Cinnagen |
2016-06-22 | PHASE3 |
| NCT03844958 | COMPLETED | Healthy |
Zhejiang University |
2017-06-15 | |
| NCT02735317 | UNKNOWN | Nasopharyngeal Neoplasms; Stomatitis |
Yun-fei Xia |
2016-04 | PHASE2 |
| NCT00655980 | COMPLETED | Major Surgery; Coronary Artery Disease |
Washington University School of Medicine |
2008-02 | |
| NCT02679443 | COMPLETED | Lung Adenocarcinoma; Neutropenia; Anemia; Thrombocytopenia; Nonsquamous Nonsmall Cell Neoplasm of Lung |
Post Graduate Institute of Medical Education and Research, Chandigarh |
2015-07 | |
| NCT03069313 | COMPLETED | Relief of Joint Pain |
Texas Tech University Health Sciences Center, El Paso |
2015-10-19 | |
| NCT01188876 | COMPLETED | Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer |
Massachusetts General Hospital |
2010-08 | PHASE1; PHASE2 |
| NCT01317849 | WITHDRAWN | Stroke; Transient Ischemic Attack |
Xijing Hospital |
2011-07 | |
| NCT02270749 | COMPLETED | Vitamin B12 Deficiency |
Rijnstate Hospital |
2014-10 | PHASE4 |
| NCT02120274 | TERMINATED | RNA Virus Infections; Flaviviridae Infections; Hepatitis C; Hepatitis C, Chronic |
Federal University of São Paulo |
2014-03 | PHASE4 |
| NCT02832726 | COMPLETED | Healthy |
University of Aarhus |
2014-01 | |
| NCT02457507 | COMPLETED | Cognitive Decline |
Chinese University of Hong Kong |
2011-08 | PHASE4 |
| NCT02679833 | COMPLETED | Cobalamin Deficiency |
Universität des Saarlandes |
2014-11 | |
| NCT01832129 | COMPLETED | Vitamin B 12 Deficiency |
University Hospital, Basel, Switzerland |
2013-05 | PHASE4 |
| NCT02013362 | COMPLETED | Peripheral T-cell Lymphoma |
Mundipharma K.K. |
2014-03 | PHASE1; PHASE2 |
| NCT01134341 | COMPLETED | Cutaneous T-cell Lymphoma; Mycosis Fungoides; Sezary Syndrome; Primary Cutaneous Anaplastic Large Cell Lymphoma |
Acrotech Biopharma Inc. |
2010-03 | PHASE1 |
| NCT03903952 | COMPLETED | ASC-US; Human Papilloma Virus |
Sanliurfa Mehmet Akif Inan Education and Research Hospital |
2014-05-01 | |
| NCT02540642 | COMPLETED | Type 2 Diabetes; Vitamin B12 Deficiency; Hyperhomocysteinemia |
Smt. Kashibai Navale Medical College and General Hospital |
2010-10 | |
| NCT01953757 | COMPLETED | Diabetic Neuropathy |
Physicians Committee for Responsible Medicine |
2013-09 | |
| NCT01127724 | TERMINATED | Recurrent Aphthous Stomatitis |
Meir Medical Center |
2012-06 | |
| NCT02076347 | COMPLETED | Type 2 Diabetes; Vitamin B12 Deficiency; Neuropathy; Anemia |
Ohio State University |
2014-02 | |
| NCT01921192 | UNKNOWN | Non Proliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy |
University of Catania |
2012-09 | PHASE4 |
| NCT01806272 | UNKNOWN | Nasopharyngeal Cancers |
Wei LUO |
2013-03 | PHASE2 |
| NCT01569919 | UNKNOWN | Malignant; Pleural; Mesothelioma |
Wales Cancer Trials Unit |
2012-12 | PHASE2 |
| NCT01661309 | COMPLETED | Vitamin B12 Deficiency |
University of West London |
2012-03 | |
| NCT01183065 | COMPLETED | Head and Neck Cancer |
Memorial Sloan Kettering Cancer Center |
2010-08 | PHASE2 |
| NCT01690962 | COMPLETED | Diabetic Neuropathy |
Physicians Committee for Responsible Medicine |
2012-11 | |
| NCT01475617 | COMPLETED | Bariatric Surgery Candidate |
Yasoo Health |
2011-11 | PHASE2; PHASE3 |
| NCT01165021 | COMPLETED | Non Small Cell Lung Cancer |
Eli Lilly and Company |
2010-11 | PHASE2 |
| NCT00659269 | COMPLETED | Cancer |
New Mexico Cancer Research Alliance |
2006-07 | PHASE3 |
| NCT00923273 | TERMINATED | Carcinoma, Non-Small-Cell Lung |
National Cancer Institute (NCI) |
2008-02-29 | PHASE1; PHASE2 |
| NCT00696514 | UNKNOWN | Osteoporosis; Cognitive Decline |
Wageningen University |
2008-09 | PHASE1 |
| NCT01762072 | UNKNOWN | Healthy |
Zhejiang University |
2013-01 | |
| NCT01474044 | COMPLETED | Chronic Atrophic Gastritis (CAG) |
Xinjiang Biochemical Pharmaceutical Co., Ltd. |
2011-08 | PHASE4 |
| NCT03522428 | COMPLETED | Pregnancy Anemia |
Mirela Zec |
2011-09-15 | PHASE4 |
| NCT01490944 | UNKNOWN | Anaemia |
Indian Council of Medical Research |
2012-01 | PHASE2 |
| NCT00998946 | COMPLETED | Lymphoma, B-Cell |
Spectrum Pharmaceuticals, Inc |
2009-09 | PHASE2 |
| NCT01795131 | COMPLETED | Nutritional Anemia in Mothers.; Nutritional Anemia in Infants. |
International Centre for Diarrhoeal Disease Research, Bangladesh |
2010-02 | PHASE2; PHASE3 |
| NCT01118624 | COMPLETED | Breast Cancer; Breast Tumors; Neoplasms, Breast; Cancer of the Breast; Human Mammary Carcinoma |
Acrotech Biopharma Inc. |
2010-03 | PHASE2 |
| NCT01057589 | COMPLETED | Head and Neck Neoplasms |
Eli Lilly and Company |
2010-02 | PHASE2 |
| NCT00554827 | COMPLETED | Cutaneous T-cell Lymphoma |
Acrotech Biopharma Inc. |
2007-08 | PHASE1 |
| NCT00835731 | COMPLETED | Cervical Ripening |
Planned Parenthood League of Massachusetts |
2009-01 | |
| NCT01297361 | COMPLETED | Vitamin B12 Deficiency; Folic Acid Deficiency |
Meir Medical Center |
2011-02 | |
| NCT00717730 | COMPLETED | Diarrhea; Pneumonia |
Tor A. Strand |
2010-01 | PHASE2 |
| NCT00481871 | COMPLETED | Relapsed or Refractory Lymphoproliferative Malignancies; Hodgkin's Lymphoma; Peripheral T-cell Lymphoma; B-cell Lymphoma; Waldenstrom's Macroglobulinemia |
Acrotech Biopharma Inc. |
2007-05 | PHASE1; PHASE2 |
| NCT00541073 | COMPLETED | Malignant Mesothelioma |
Centre Oscar Lambret |
2007-06 | PHASE2 |
| NCT01306123 | COMPLETED | Focus: Bioavailability |
Swedish Orphan Biovitrum |
2011-02 | PHASE1 |
| NCT01876732 | COMPLETED | Vitamin B12 Deficiency |
Northwell Health |
2009-06 | |
| NCT00722553 | COMPLETED | Carcinoma, Transitional Cell; Bladder Cancer; Bladder Neoplasm |
Acrotech Biopharma Inc. |
2008-07 | PHASE2 |
| NCT00730574 | TERMINATED | B12 Deficiency Combined With C677T Mutation on MTHFR Gene |
Moshe Flugelman |
2008-07 | |
| NCT00641862 | COMPLETED | Pregnancy |
Harvard School of Public Health (HSPH) |
2008-12 | |
| NCT00214682 | COMPLETED | Depression; Depressive Disorder |
Australian National University |
2005-10 | PHASE2 |
| NCT00326833 | UNKNOWN | Vitamin B12 Deficiency |
University of Aarhus |
2006-01 | PHASE4 |
| NCT00227019 | COMPLETED | Non-small Cell Lung Cancer (NSCLC); Lung Cancer; Neoplasm Metastasis |
Heather Wakelee |
2006-03 | PHASE2 |
| NCT01194453 | COMPLETED | Non-small Cell Lung Cancer; Efficacy |
Sun Yat-sen University |
2009-11 | PHASE2 |
| NCT00710359 | COMPLETED | Vitamin B 12 Deficiency |
Haukeland University Hospital |
2008-04 | |
| NCT00710138 | COMPLETED | Vitamin B 12 Deficiency |
Haukeland University Hospital |
2008-06 | |
| NCT00606502 | COMPLETED | Non-small Cell Lung Cancer |
Spectrum Pharmaceuticals, Inc |
2008-01 | PHASE2 |
| NCT00853879 | TERMINATED | Parkinson's Disease |
Northwell Health |
2006-12 | |
| NCT00939718 | UNKNOWN | Major Depressive Disorder |
Aga Khan University |
2009-04 | |
| NCT00348933 | COMPLETED | Angelman Syndrome; Nervous System Diseases |
University of California, San Diego |
2006-07 | |
| NCT00208611 | TERMINATED | Parkinson's Disease |
Emory University |
2006-09 | PHASE2; PHASE3 |
| NCT00901394 | COMPLETED | Cardiovascular Abnormalities |
Washington University School of Medicine |
2009-03 | |
| NCT00609518 | COMPLETED | Non Small Cell Lung Cancer |
Eli Lilly and Company |
2008-02 | PHASE2 |
| NCT00730093 | COMPLETED | Pregnancy |
University of Aarhus |
2008-08 | |
| NCT00216099 | COMPLETED | Prostate Cancer |
Christopher Sweeney, MBBS |
2005-02 | PHASE2 |
| NCT00364923 | COMPLETED | Peripheral T-cell Lymphoma |
Acrotech Biopharma Inc. |
2006-08 | PHASE2 |
| NCT00402883 | TERMINATED | Lung Cancer |
SCRI Development Innovations, LLC |
2006-11 | PHASE2 |
| NCT00164970 | COMPLETED | Dementia |
Chinese University of Hong Kong |
2004-10 | PHASE4 |
| NCT00699478 | COMPLETED | Vitamin B12 Deficiency |
Yonsei University |
2008-04 | PHASE2 |
| NCT00124072 | COMPLETED | Cardiovascular Disease |
University of Oxford |
1998-07 | PHASE3 |
| NCT00843453 | COMPLETED | Vitamin B12 Deficiency |
University of Delaware |
2006-11 | |
| NCT00288769 | COMPLETED | Recurrent Aphthous Stomatitis |
Soroka University Medical Center |
2006-03 | |
| NCT00120484 | COMPLETED | Sleep Disorders, Circadian Rhythm |
Brigham and Women's Hospital |
2005-04 | |
| NCT00354081 | COMPLETED | Coronary Artery Disease; Myocardial Infarction; Cerebrovascular Stroke |
Haukeland University Hospital |
1999-04 | PHASE3 |
| NCT00056225 | COMPLETED | Alzheimer's Disease |
National Institute on Aging (NIA) |
2003-01 | PHASE3 |
| NCT00693589 | COMPLETED | Cardiovascular Disease; Endothelial Dysfunction |
Insel Gruppe AG, University Hospital Bern |
2005-01 | PHASE2 |
| NCT00114400 | COMPLETED | Atherosclerosis |
National Institute on Aging (NIA) |
2000-11 | PHASE2; PHASE3 |
| NCT04731948 | COMPLETED | Healthy |
University of Ulster |
2004-10-01 | |
| NCT00202280 | COMPLETED | First Episode Psychosis |
Melbourne Health |
2004-09 | PHASE2; PHASE3 |
| NCT00479479 | COMPLETED | Vitamin B 12 Deficiency |
Haukeland University Hospital |
2004-12 | |
| NCT00235573 | COMPLETED | Disorder of Vitamin B12 |
University of Florida |
2005-10 | |
| NCT00826657 | COMPLETED | Vitamin B12 Deficiency |
USDA, Western Human Nutrition Research Center |
2004-10 | |
| NCT00000541 | COMPLETED | Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia |
Brigham and Women's Hospital |
1993-05 | PHASE2 |
| NCT00353353 | COMPLETED | Healthy |
Wageningen Centre for Food Sciences |
2006-07 | |
| NCT00165711 | COMPLETED | Dementia With Vitamin B12 Deficiency |
Eisai Co., Ltd. |
2003-03 | PHASE4 |
| NCT00266487 | COMPLETED | Acute Myocardial Infarction |
University of Tromso |
1998-12 | |
| NCT00279552 | COMPLETED | Vitamin B12 Deficiency |
University of Aarhus |
2004-04 | PHASE2 |
| NCT01312831 | COMPLETED | Vitamin B 12 Deficiency |
Emisphere Technologies, Inc. |
2009-02 | |
| NCT00730509 | COMPLETED | Cystic Fibrosis |
Universita di Verona |
2004-04 | |
| NCT00306358 | COMPLETED | Vitamin B12 Absorption |
University of Aarhus |
2005-05 | |
| NCT00111267 | COMPLETED | Cognitive Decline; Cognitive Symptoms |
Wageningen University |
2003-05 | |
| NCT00403247 | COMPLETED | Schizophrenia; Schizoaffective Disorder |
Nathan Kline Institute for Psychiatric Research |
2004-07 | |
| NCT00350116 | COMPLETED | Chronic Plaque Psoriasis |
Ruhr University of Bochum |
2001-01 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2025-05-13)
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>).