Clinical Trials

Numerous clinical trials evaluate thymidine across early phase 1 through phase 4 stages and non-applicable designs, investigating conditions ranging from viral pathologies like HIV and renal impairments to oncological indications including colorectal carcinoma, brain neoplasms, and uterine corpus cancer. Sponsored by major governmental bodies—such as the National Cancer Institute and the National Institute of Allergy and Infectious Diseases—alongside academic medical centers, these protocols encompass diverse recruitment statuses, including active, recruiting, completed, suspended, terminated, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01199250 Not yet recruiting
Lynch Syndrome|Recurrent Uterine Corpus Carcinoma|Stage I Uterine Corpus Cancer|Stage II Uterine Corpus Cancer|Stage III Uterine Corpus Cancer|Stage IV Uterine Corpus Cancer
Gynecologic Oncology Group|National Cancer Institute (NCI)|GOG Foundation
2100-01 --
NCT04598516 Withdrawn
Acute Kidney Injury (Nontraumatic)|Contrast-induced Nephropathy|Renal Insufficiency
Maastricht University Medical Center
2097-11-01 --
NCT04713657 RECRUITING
Tetralogy of Fallot; Double Outlet Right Ventricle
Weill Medical College of Cornell University
2022-12-16 PHASE1
NCT04802707 RECRUITING
Mitochondrial Diseases; Mitochondrial Encephalomyopathy; Mitochondrial Encephalopathy; Mitochondrial DNA Depletion; Mitochondrial Metabolism Disorders
Kenneth Myers, MD
2021-10-18 PHASE2
NCT04968964 RECRUITING
Breast Cancer; Cancer of the Breast
Washington University School of Medicine
2022-03-07
NCT06817590 RECRUITING
Telomere Biology Disorders; Dyskeratosis Congenita; Revesz Syndrome; Hoyeraal Hreidarsson Syndrome; Telomere Biology Disorders With Bone Marrow Failure; Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder); Pulmonary Fibrosis, Familial (Telomere Biology Disorder)
Suneet Agarwal
2025-09-29 PHASE1
NCT05454306 Suspended
Clavicle Fracture
University of Minnesota
2028-01-09 Not Applicable
NCT03866954 WITHDRAWN
Mitochondrial Diseases; Metabolic Disease; Inborn Errors of Metabolism
St George's, University of London
2024-11 PHASE2
NCT04795856 Not yet recruiting
Mitral Valve Regurgitation
University of Alabama at Birmingham
2027-06-18 Early Phase 1
NCT06587165 RECRUITING
Tetralogy of Fallot With Pulmonary Stenosis; Heart Failure
Weill Medical College of Cornell University
2026-05-15
NCT06754098 RECRUITING
Thymidine Kinase 2 (TK2 ) Deficiency; Mitochondrial Myopathies
Cristina Domínguez González
2025-01-01 PHASE2
NCT06359262 Not yet recruiting
Mental Health Wellness 1
Karolinska Institutet
2027-01-01 Not Applicable
NCT03639701 ACTIVE_NOT_RECRUITING
Mitochondrial DNA Depletion Syndrome 2 Myopathic Type; Thymidine Kinase 2 Deficiency
Columbia University
2017-05-16 PHASE1; PHASE2
NCT03845712 ACTIVE_NOT_RECRUITING
Thymidine Kinase 2 Deficiency
UCB BIOSCIENCES, Inc.
2019-07-05 PHASE2
NCT04581733 WITHDRAWN
Thymidine Kinase 2 Deficiency
Zogenix MDS, Inc.
2022-09-30 PHASE3
NCT04313868 COMPLETED
Hepatocellular Carcinoma; Metastatic Cancer
GenVivo, Inc.
2014-06-13 PHASE1
NCT03294083 COMPLETED
Renal Cell Carcinoma
SillaJen, Inc.
2018-06-19 PHASE1; PHASE2
NCT04849260 UNKNOWN
Local Progression or Metastatic Melanoma With Failed First-line Treatment
Lee's Pharmaceutical Limited
2021-08-26 PHASE1; PHASE2
NCT02562755 COMPLETED
Hepatocellular Carcinoma (HCC)
SillaJen, Inc.
2015-10 PHASE3
NCT03546556 TERMINATED
Graft Vs Host Disease
UNC Lineberger Comprehensive Cancer Center
2017-01-01 EARLY_PHASE1
NCT02274038 TERMINATED
Non-small Cell Lung Cancer; Starting Pemetrexed Based Therapy; Unresectable Cancer
University of Pennsylvania
2015-03
NCT02069418 UNKNOWN
Non-small Cell Lung Cancer Metastatic or Non-small Cell Lung Cancer Recurrent; No EGFR Activating Mutation
University Hospital, Angers
2014-02 PHASE2
NCT02241668 WITHDRAWN
Brain Tumor
M.D. Anderson Cancer Center
2015-06
NCT02017678 WITHDRAWN
Ovarian Cancer
Andrea McCart
2014-01 PHASE2
NCT01738555 WITHDRAWN
Human Immunodeficiency Virus Infection
RFS Pharma, LLC
2013-04 PHASE2
NCT00978237 COMPLETED
HIV Infections; Lipoatrophy
Juan A. Arnaiz
2009-10 PHASE4
NCT01280643 TERMINATED
Metastatic Colorectal Cancer
Fox Chase Cancer Center
2010-03
NCT00982449 COMPLETED
Hodgkin Lymphoma; Non Hodgkin Lymphoma; Kaposi's Sarcoma; Gastric Cancer; Nasopharyngeal Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2010-12
NCT01636284 COMPLETED
Hepatocellular Carinoma
Jennerex Biotherapeutics
2012-06 PHASE2
NCT01065818 TERMINATED
Esophageal Cancer; Non-small Cell Lung Cancer
Columbia University
2009-08
NCT01737359 TERMINATED
Human Immunodeficiency Virus Infection
RFS Pharma, LLC
2012-12 PHASE2
NCT01207895 COMPLETED
Rectal Cancer
Vanderbilt-Ingram Cancer Center
2010-03 PHASE1
NCT01380600 COMPLETED
Carcinoma, Colorectal
Jennerex Biotherapeutics
2010-09-08 PHASE1
NCT01469611 COMPLETED
Colorectal Carcinoma
Samsung Medical Center
2010-07 PHASE1
NCT01047059 COMPLETED
Non-Small-Cell Lung Carcinoma
University of Cologne
2010-01 PHASE2
NCT00534274 COMPLETED
Breast Cancer
UNICANCER
2006-11
NCT01169584 COMPLETED
Neuroblastoma; Rhabdomyosarcoma; Lymphoma; Wilm's Tumor; Ewing's Sarcoma
Jennerex Biotherapeutics
2010-08 PHASE1
NCT01329809 TERMINATED
Colorectal Carcinoma
Jennerex Biotherapeutics
2011-10 PHASE2
NCT00145665 TERMINATED
Colorectal Neoplasms; Liver Neoplasms
Radboud University Medical Center
2005-01 PHASE1; PHASE2
NCT00554372 COMPLETED
Carcinoma, Hepatocellular
Jennerex Biotherapeutics
2008-08 PHASE2
NCT00870181 COMPLETED
Malignant Glioma of Brain; Glioblastoma
Huazhong University of Science and Technology
2008-01 PHASE2
NCT00624728 COMPLETED
High-grade Glioma; Astrocytoma; Glioblastoma
University Hospital, Bordeaux
2008-02 PHASE1; PHASE2
NCT00001328 COMPLETED
Brain Neoplasm; Neoplasm Metastasis
National Institute of Neurological Disorders and Stroke (NINDS)
1992-08-21 PHASE1
NCT00625456 COMPLETED
Melanoma; Lung Cancer; Renal Cell Carcinoma; Squamous Cell Carcinoma of the Head and Neck
Jennerex Biotherapeutics
2008-06 PHASE1
NCT00429312 COMPLETED
Melanoma
Jennerex Biotherapeutics
2007-02 PHASE1; PHASE2
NCT00629759 COMPLETED
Neoplasms, Liver
Jennerex Biotherapeutics
2006-01 PHASE1
NCT00156312 COMPLETED
Breast Cancer
University of Michigan Rogel Cancer Center
2003-07
NCT00647946 COMPLETED
Lipodystrophy
Gilead Sciences
2003-02 PHASE2
NCT00844623 COMPLETED
Carcinoma, Hepatocellular
Clinica Universidad de Navarra, Universidad de Navarra
2002-12 PHASE1
NCT00000982 COMPLETED
Encephalopathies; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE2
NCT00001008 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00001005 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE1
NCT00000701 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE1
NCT00000702 COMPLETED
AIDS Dementia Complex; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE3
NCT00001298 COMPLETED
Kidney Diseases
National Cancer Institute (NCI)
1992-03 PHASE1
NCT00028314 COMPLETED
HIV Infections; Lipodystrophy; Wasting Disease
National Institute of Allergy and Infectious Diseases (NIAID)
2002-03
NCT00264446 COMPLETED
Neoplasms
Adherex Technologies, Inc.
PHASE1
NCT00005057 COMPLETED
Melanoma (Skin)
National Human Genome Research Institute (NHGRI)
2000-03 PHASE1
NCT00002263 COMPLETED
HIV Infections; Cytopenias
Sandoz
NCT00000994 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE3
NCT00000686 TERMINATED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE1
NCT00002006 COMPLETED
HIV Infections; Cytopenias
Sandoz
PHASE1
NCT00002284 COMPLETED
Lymphoma, Non-Hodgkin; HIV Infections
Glaxo Wellcome
NCT00000723 TERMINATED
Lymphoma, Non-Hodgkin; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00300521 COMPLETED
Hepatocellular Carcinoma; Liver Transplantation
Beijing Chao Yang Hospital
2000-09 PHASE2
NCT00002308 COMPLETED
HIV Infections
Bristol-Myers Squibb
NCT00001001 COMPLETED
HIV Infections; Liver Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00270556 COMPLETED
HIV
Gilead Sciences
2003-01 PHASE2
NCT00001282 COMPLETED
HIV Infection
National Institute of Allergy and Infectious Diseases (NIAID)
1991-07 PHASE2
NCT00000789 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE2
NCT00000706 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000987 COMPLETED
Sarcoma, Kaposi; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE1
NCT00002007 COMPLETED
HIV Infections; Cytopenias
Sandoz
NCT00000703 COMPLETED
Lymphoma, Non-Hodgkin; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000705 COMPLETED
HIV Infections; Hemophilia A
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE1
NCT00000694 COMPLETED
Sarcoma, Kaposi; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE1
NCT00004658 COMPLETED
5'-Nucleotidase Syndrome
National Center for Research Resources (NCRR)
1995-03 PHASE2
NCT00000988 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE1
NCT00000727 COMPLETED
Pneumonia, Pneumocystis Carinii; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE3
NCT00000718 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000700 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE3
NCT00005025 UNKNOWN
Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
John Stoddard Cancer Center at Iowa Methodist Medical Center
2000-06 PHASE2
NCT00002276 COMPLETED
HIV Infections; Hemophilia A
University of Pittsburgh
NCT00002271 COMPLETED
HIV Infections
Lederle Laboratories

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Thymidine is a pyrimidine nucleoside that undergoes sequential intracellular phosphorylation by thymidine kinase into thymidine triphosphate, serving as an essential precursor for DNA polymerase during genomic replication. Exogenous modulation or administration of thymidine and its analogs disrupts balanced nucleotide pools and halts DNA chain elongation, thereby inhibiting cellular proliferation in oncological conditions such as colorectal carcinoma and brain neoplasms or suppressing viral replication in HIV infections.

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>).

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Note: Technical data last updated: Sep 1, 2026.