Clinical Trials

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)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Uridine incorporates into cellular pyrimidine nucleotide pathways to modulate intracellular pyrimidine metabolism and regulate downstream nucleic acid synthesis. This alteration of nucleotide homeostasis inhibits cellular proliferation and impacts cellular bioenergetics, providing a mechanistic basis for its clinical investigation in conditions such as colorectal cancer, ischemic stroke, and acute myeloid leukemia.

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.