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protocols encompass diverse recruitment statuses, including active, recruiting, completed, suspended, terminated, and withdrawn.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| NCT04598516 | Withdrawn | Acute Kidney Injury (Nontraumatic)|Contrast-induced Nephropathy|Renal Insufficiency |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| NCT03866954 | WITHDRAWN | Mitochondrial Diseases; Metabolic Disease; Inborn Errors of Metabolism |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 |
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| 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) |
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| NCT00300521 | COMPLETED | Hepatocellular Carcinoma; Liver Transplantation |
Beijing Chao Yang Hospital |
2000-09 | PHASE2 |
| NCT00002308 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
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| NCT00001001 | COMPLETED | HIV Infections; Liver Diseases |
National Institute of Allergy and Infectious Diseases (NIAID) |
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| 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) |
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| 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) |
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| 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) |
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| 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 |
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| NCT00002271 | COMPLETED | HIV Infections |
Lederle Laboratories |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
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>).