Numerous clinical trials evaluate uridine and related therapeutic regimens across conditions including ischemic stroke, colorectal cancer, acute myeloid leukemia, myelodysplastic syndromes, Alzheimer's disease, and HIV. Spanning Early Phase 1 through Phase 4 alongside non-applicable nutritional designs, these studies comprise active, recruiting, completed, and terminated statuses. They are funded by various sponsors, including academic medical centers, NHS trusts, and industry entities such as Janssen Research & Development, Danone Nutricia Research, and Memorial Sloan Kettering Cancer Center.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07764497 | RECRUITING | Colorectal Adenocarcinoma Metastatic in the Liver; Liver Metastasis Colon Cancer; Liver Metastases From Colorectal Cancer; Liver Metastases of Colorectal Cancer |
Sunnybrook Health Sciences Centre |
2014-07 | PHASE2 |
| NCT06313203 | RECRUITING | Intrahepatic Cholangiocarcinoma; Chemotherapy Effect |
Oslo University Hospital |
2024-02-13 | PHASE2 |
| NCT07435636 | NOT_YET_RECRUITING | Clonal Cytopenia of Uncertain Significance; CCUS Clonal Cytopenia of Undetermined Significance; Clonal Hematopoiesis |
Clinical Hub for Interventional Research (CHOIR) |
2026-04-13 | PHASE2 |
| NCT06857773 | RECRUITING | Colorectal Neoplasms; Floxuridine; Liver Metastases; Vascular Access Device |
The Netherlands Cancer Institute |
2024-11-21 | PHASE3 |
| NCT05863195 | RECRUITING | Metastatic Colorectal Carcinoma; Metastatic Malignant Neoplasm in the Liver; Stage IV Colorectal Cancer AJCC v8; Unresectable Colorectal Carcinoma |
ECOG-ACRIN Cancer Research Group |
2023-10-19 | PHASE3 |
| NCT03856658 | ACTIVE_NOT_RECRUITING | Pancreatic Adenocarcinoma; Liver Metastases |
Corewell Health West |
2019-02-05 | PHASE2 |
| NCT05286814 | RECRUITING | Metastatic Colorectal Cancer (Mcrc); Intrahepatic Cholangiocarcinoma (Icc); Intrahepatic Bile Duct Cancer; Colorectal Neoplasms; Colorectal Cancer; Cholangiocarcinoma; Bile Duct Neoplasms; Bile Duct Cancer; Adrenocortical Carcinoma (ACC); Adrenal Cortical Carcinoma; Adrenal Gland Cancer; Adrenal Gland Neoplasms; Adrenal Cortex Neoplasms |
National Cancer Institute (NCI) |
2022-10-24 | PHASE2 |
| NCT04891289 | RECRUITING | Intrahepatic Cholangiocarcinoma |
Memorial Sloan Kettering Cancer Center |
2021-05-07 | PHASE2 |
| NCT00492999 | ACTIVE_NOT_RECRUITING | Colorectal Cancer; Metastatic Cancer |
Memorial Sloan Kettering Cancer Center |
2007-05 | PHASE2 |
| NCT04055818 | RECRUITING | Sickle Cell Disease |
EpiDestiny, Inc. |
2020-01-24 | PHASE1 |
| NCT03366155 | COMPLETED | Colorectal Cancer; Liver Metastases; Colorectal Adenocarcinoma; Colorectal Cancer With Hepatic Metastases; Colorectal Carcinoma |
National Cancer Institute (NCI) |
2019-06-24 | PHASE2 |
| NCT04898504 | ACTIVE_NOT_RECRUITING | Colorectal Cancer; Liver Metastases; Chemotherapy Effect |
Oslo University Hospital |
2021-08-23 | PHASE2 |
| NCT00059930 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
Memorial Sloan Kettering Cancer Center |
2003-01 | PHASE1 |
| NCT01862315 | COMPLETED | Intrahepatic Cholangiocarcinoma; Peripheral Cholangiocarcinoma; Cholangiolar Carcinoma; Cholangiocellular Carcinoma |
Memorial Sloan Kettering Cancer Center |
2013-05 | PHASE2 |
| NCT04879368 | COMPLETED | Gastro-Oesophageal Cancer |
Australasian Gastro-Intestinal Trials Group |
2021-05-05 | PHASE3 |
| NCT02102789 | UNKNOWN | Metastatic Colorectal Cancer |
Yuhong Li |
2014-03 | PHASE3 |
| NCT03265964 | COMPLETED | Suicidal Ideation |
VA Office of Research and Development |
2018-04-02 | PHASE4 |
| NCT03693807 | COMPLETED | Colorectal Cancer; Cholangiocarcinoma |
Memorial Sloan Kettering Cancer Center |
2018-10-18 | PHASE2 |
| NCT00410956 | COMPLETED | Liver Cancer |
Memorial Sloan Kettering Cancer Center |
2007-05-09 | PHASE2 |
| NCT04251715 | TERMINATED | Liver and Intrahepatic Bile Duct Carcinoma; Stage III Intrahepatic Cholangiocarcinoma AJCC v8; Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8; Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8; Stage IV Intrahepatic Cholangiocarcinoma AJCC v8; Unresectable Intrahepatic Cholangiocarcinoma |
OHSU Knight Cancer Institute |
2021-04-28 | PHASE2 |
| NCT04668976 | UNKNOWN | Colorectal Cancer; Cholangiocarcinoma |
Benaroya Research Institute |
2020-11-25 | PHASE2 |
| NCT05474105 | Recruiting | Ischemic Stroke |
Barts & The London NHS Trust|Queen Mary University of London|Nutricia Research |
2023-07-11 | Not Applicable |
| NCT05816356 | COMPLETED | Healthy |
EpiDestiny, Inc. |
2023-03-24 | PHASE1 |
| NCT05655780 | Recruiting | Colorectal Neoplasms |
Maastricht University Medical Center|Maastricht University|Wageningen University & Research|Fontys Hogeschool|Amsterdam UMC - Locatie AMC|Erasmus Medical Center|Catharina Ziekenhuis|University of North Carolina (USA)|Oncology patientenpanel MUMC|Stichting Kanker.nl|Van Weel-Bethesda Ziekenhuis|VieCuri Medisch Centrum voor Noord-Limburg|Gelderse Vallei Hospital|Danone Nutricia Research|Clinical Trial Center Maastricht B.V.|Dutch Colorectal Cancer Group (DCCG)|Prospectief Landelijk CRC Cohort (PLCRC)|CRC-guideline committee|CZ zorgverzekeraar|Landelijke Werkgroep Diëtisten Oncologie (LWDO) |
2023-01-09 | -- |
| NCT03678428 | TERMINATED | Metastatic Colorectal Cancer; Liver Metastases |
Sun Yat-sen University |
2021-12-31 | PHASE3 |
| NCT05294484 | UNKNOWN | Pharmacogenomics |
Ain Shams University |
2022-03-15 | PHASE4 |
| NCT04552093 | UNKNOWN | Colorectal Neoplasms |
The Netherlands Cancer Institute |
2020-09-09 | PHASE2; PHASE3 |
| NCT03233724 | TERMINATED | Carcinoma, Non-Small-Cell Lung; Lung Cancer; Non-Small Cell Lung Cancer; Carcinoma, Esophageal; Malignant Pleural Mesotheliomas |
National Cancer Institute (NCI) |
2018-04-11 | PHASE1; PHASE2 |
| NCT03500874 | TERMINATED | Colorectal Cancer; Liver Metastases; HAI |
Sun Yat-sen University |
2018-05-28 | PHASE3 |
| NCT04902105 | COMPLETED | Drug Interaction |
Emalex Biosciences Inc. |
2021-05-13 | PHASE1 |
| NCT00695201 | COMPLETED | Colon Cancer; Rectal Cancer |
Memorial Sloan Kettering Cancer Center |
2000-08 | PHASE1 |
| NCT03738943 | COMPLETED | Receptor Blockade |
Colorado State University |
2019-02-07 | EARLY_PHASE1 |
| NCT04800159 | Recruiting | HIV|Cannabis Use |
University of California San Diego|Center for Medicinal Cannabis Research |
2021-02-19 | Phase 2 |
| NCT03493061 | COMPLETED | Colo-rectal Cancer; Liver Metastases |
Sun Yat-sen University |
2018-02-01 | PHASE2 |
| NCT04609826 | Active not recruiting | Acute Myeloid Leukemia|Myelodysplastic Syndromes|Chronic Myelomonocytic Leukemia |
Janssen Research & Development LLC |
2020-11-26 | Phase 1 |
| NCT01938729 | COMPLETED | Intrahepatic Cholangiocarcinoma; Peripheral Cholangiocarcinoma; Cholangiolar Carcinoma; Cholangiocellular Carcinoma) (ICC) |
Memorial Sloan Kettering Cancer Center |
2013-09-05 | PHASE1 |
| NCT02529774 | UNKNOWN | Resected Liver Metastases From Colorectal Cancer |
Ye Xu |
2015-09 | PHASE2; PHASE3 |
| NCT04086238 | COMPLETED | Healthy |
EpiDestiny, Inc. |
2019-10-08 | PHASE1 |
| NCT01534598 | COMPLETED | Neoplasms |
National Cancer Institute (NCI) |
2012-03-05 | PHASE1 |
| NCT02664181 | COMPLETED | Lung Cancer; Non-small Cell Lung Cancer |
Case Comprehensive Cancer Center |
2017-06-06 | PHASE2 |
| NCT03069950 | WITHDRAWN | Colorectal Adenocarcinoma Metastatic to the Liver |
Memorial Sloan Kettering Cancer Center |
2017-02-28 | PHASE2 |
| NCT03828084 | COMPLETED | Healthy |
EpiDestiny, Inc. |
2019-04-03 | PHASE1 |
| NCT00978250 | COMPLETED | Head and Neck Neoplasms; Lung Neoplasms; Urinary Bladder Neoplasms; Breast Neoplasms |
National Cancer Institute (NCI) |
2009-08-20 | PHASE2 |
| NCT01525069 | TERMINATED | Cholangiocarcinoma; Liver Neoplasms |
Washington University School of Medicine |
2012-04-03 | PHASE1 |
| NCT01685515 | COMPLETED | Sickle Cell Disease |
Yogen Saunthararajah |
2012-08 | PHASE1 |
| NCT00645710 | COMPLETED | Liver Metastases; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer |
City of Hope Medical Center |
2005-02-11 | PHASE1; PHASE2 |
| NCT02846935 | COMPLETED | T-cell Lymphoma; Aggressive B-cell Lymphoma; Non-Hodgkin's Lymphomas; Indolent B-cell Lymphoma |
Yogen Saunthararajah |
2017-04-25 | EARLY_PHASE1 |
| NCT03876574 | COMPLETED | Nasopharyngeal Carcinoma; Neoplasm Metastasis; Liver |
Xiangya Hospital of Central South University |
2011-01-01 | PHASE1 |
| NCT02847000 | COMPLETED | Metastatic Pancreatic Adenocarcinoma |
Yogen Saunthararajah |
2016-12-20 | EARLY_PHASE1 |
| NCT01749397 | COMPLETED | Stage IV Fallopian Tube Cancer AJCC v6 and v7; Stage IV Ovarian Cancer AJCC v6 and v7; Stage IV Primary Peritoneal Cancer AJCC v7 |
National Cancer Institute (NCI) |
2012-12-07 | PHASE1 |
| NCT01479348 | TERMINATED | Head and Neck Neoplasms; Lung Neoplasms; Urinary Bladder Neoplasms; Breast Neoplasms |
National Cancer Institute (NCI) |
2011-11-01 | EARLY_PHASE1 |
| NCT02839694 | WITHDRAWN | Neoplasm Metastasis; Sarcoma; Neoplasms, Germ Cell and Embryonal; Melanoma |
National Cancer Institute (NCI) |
2016-07-07 | PHASE1 |
| NCT02511041 | TERMINATED | PGM3 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2015-06-30 | PHASE1 |
| NCT00587067 | COMPLETED | Hepatic Cancer |
Memorial Sloan Kettering Cancer Center |
2003-06 | PHASE2 |
| NCT01805440 | COMPLETED | Bipolar Disorder; Bipolar Depression; Manic Depression |
University of Utah |
2013-08 | |
| NCT02110147 | COMPLETED | Hereditary Orotic Aciduria |
Wellstat Therapeutics |
2014-04 | PHASE3 |
| NCT02249468 | Terminated | Mild and Moderate Alzheimer''s Disease|Cognitively Healthy People |
Danone Nutricia Research |
2014-10 | -- |
| NCT00521183 | COMPLETED | Brain and Central Nervous System Tumors |
Brian Lally |
2007-06 | PHASE1 |
| NCT00002842 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
City of Hope Medical Center |
1994-09 | PHASE2 |
| NCT01041443 | COMPLETED | Adult Acute Myeloid Leukemia; de Novo Myelodysplastic Syndromes; Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes; Untreated Adult Acute Myeloid Leukemia |
City of Hope Medical Center |
2009-12 | PHASE1 |
| NCT00841269 | COMPLETED | Bipolar Disorder |
University of Utah |
2009-05 | PHASE2 |
| NCT00359606 | COMPLETED | Neoplasms |
City of Hope Medical Center |
1999-04 | PHASE1 |
| NCT00471614 | COMPLETED | HIV Infections; Insulin Resistance; Hyperlactatemia |
National Center for Complementary and Integrative Health (NCCIH) |
2007-04 | PHASE2 |
| NCT00848783 | TERMINATED | Gastric Cancer; Gastric Adenocarcinoma; Esophageal Cancer |
NYU Langone Health |
2008-05 | PHASE2 |
| NCT02426554 | COMPLETED | Children |
University of Copenhagen |
2011-01 | |
| NCT00812058 | COMPLETED | Bipolar I Depression |
Repligen Corporation |
2008-11 | PHASE2 |
| NCT00448760 | COMPLETED | Esophageal Cancer |
University of Miami |
2004-10 | PHASE2 |
| NCT00449163 | TERMINATED | Colorectal Cancer |
University of Miami |
2006-03-01 | PHASE2 |
| NCT00448682 | TERMINATED | Gastric Cancer |
University of Miami |
2005-06 | PHASE2 |
| NCT00643877 | UNKNOWN | Colorectal Neoplasms |
Fudan University |
2008-12 | PHASE3 |
| NCT00408551 | UNKNOWN | Colorectal Cancer; Metastatic Cancer |
Goshen Health System |
2005-11 | PHASE2 |
| NCT00307164 | COMPLETED | HIV Infections; Lipoatrophy |
National Institute of Allergy and Infectious Diseases (NIAID) |
2006-09 | PHASE2; PHASE3 |
| NCT01261260 | COMPLETED | Healthy Male Subjects |
Mclean Hospital |
2006-11 | PHASE1 |
| NCT00268463 | TERMINATED | Colorectal Cancer; Metastatic Cancer |
NSABP Foundation Inc |
2006-01 | PHASE3 |
| NCT00077051 | COMPLETED | Head and Neck Cancer |
University of Miami |
2004-04 | PHASE1 |
| NCT00004103 | COMPLETED | Gastric Cancer |
NYU Langone Health |
1998-07 | PHASE2 |
| NCT00858338 | COMPLETED | Gastric Cancer; Stomach Cancer |
NYU Langone Health |
2002-12 | PHASE2 |
| NCT00004233 | COMPLETED | Esophageal Cancer; Gastric Cancer |
SWOG Cancer Research Network |
2001-02 | PHASE2 |
| NCT00183911 | COMPLETED | Gastric Adenocarcinoma; Gastric Cancer |
University of Southern California |
2003-11 | PHASE2 |
| NCT00005049 | COMPLETED | Colorectal Cancer; Gastric Cancer; Gastrointestinal Carcinoid Tumor; Gastrointestinal Stromal Tumor; Ovarian Cancer; Peritoneal Cavity Cancer; Small Intestine Cancer |
NYU Langone Health |
1997-05 | PHASE2 |
| NCT00008294 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
Memorial Sloan Kettering Cancer Center |
2000-08 | PHASE1 |
| NCT00002716 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
Alliance for Clinical Trials in Oncology |
1996-01 | PHASE3 |
| NCT00024427 | COMPLETED | Drug/Agent Toxicity by Tissue/Organ; Pancreatic Cancer |
Wellstat Therapeutics |
2001-02 | PHASE3 |
| NCT00026234 | COMPLETED | Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum; Liver Metastases; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer |
National Cancer Institute (NCI) |
2002-02 | PHASE2 |
| NCT00063960 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
Alliance for Clinical Trials in Oncology |
2003-08 | PHASE2 |
| NCT00003753 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
Memorial Sloan Kettering Cancer Center |
1998-09 | PHASE2 |
| NCT00004142 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
M.D. Anderson Cancer Center |
1998-08-05 | PHASE2 |
| NCT00210080 | COMPLETED | Lung Cancer |
Merck Sharp & Dohme LLC |
2001-04 | PHASE3 |
| NCT00006038 | COMPLETED | Esophageal Cancer; Gastric Cancer |
Memorial Sloan Kettering Cancer Center |
2000-02 | PHASE2 |
| NCT00003832 | COMPLETED | Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer |
National Cancer Institute (NCI) |
1999-07 | PHASE2 |
| NCT00002783 | COMPLETED | Gastric Cancer |
Memorial Sloan Kettering Cancer Center |
1996-05 | PHASE2 |
| NCT00003405 | WITHDRAWN | Leukemia |
Rush University Medical Center |
1998-04 | PHASE2 |
| NCT00322764 | COMPLETED | Bipolar Depression |
Repligen Corporation |
2006-03 | PHASE2 |
| NCT00001576 | COMPLETED | Colorectal Neoplasm; Liver Neoplasm; Neoplasm Metastasis |
National Cancer Institute (NCI) |
1997-07 | PHASE1 |
| NCT00008255 | COMPLETED | Lung Cancer |
Memorial Sloan Kettering Cancer Center |
2000-08 | PHASE2 |
| NCT00001449 | COMPLETED | Neoplasms |
National Cancer Institute (NCI) |
1995-09 | PHASE1 |
| NCT00033527 | UNKNOWN | Lung Cancer |
Jonsson Comprehensive Cancer Center |
||
| NCT00004658 | COMPLETED | 5'-Nucleotidase Syndrome |
National Center for Research Resources (NCRR) |
1995-03 | PHASE2 |
| NCT00004705 | COMPLETED | Cystic Fibrosis |
FDA Office of Orphan Products Development |
1996-09 | |
| NCT00044785 | TERMINATED | Solid Tumors |
Wellstat Therapeutics |
2002-08 | PHASE1 |
| NCT00060515 | TERMINATED | Mitochondrial Diseases |
Repligen Corporation |
PHASE1 | |
| NCT00005860 | COMPLETED | Cancer |
Memorial Sloan Kettering Cancer Center |
2000-04 | PHASE1 |
| NCT00020501 | COMPLETED | Colorectal Cancer; Metastatic Cancer |
National Institutes of Health Clinical Center (CC) |
2001-03 | PHASE3 |
| NCT00264446 | COMPLETED | Neoplasms |
Adherex Technologies, Inc. |
PHASE1 | |
| NCT00019760 | COMPLETED | Recurrent Colon Cancer; Liver Metastases; Stage IV Rectal Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer |
National Institutes of Health Clinical Center (CC) |
1999-04 | PHASE2 |
| NCT00128947 | COMPLETED | Healthy |
National Institutes of Health Clinical Center (CC) |
2005-07 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-14)
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>).