Clinical Trials

Multiple clinical trials sponsored by organizations such as St George's University of London, Neovii Biotech, Assistance Publique - Hôpitaux de Paris, and university hospital networks evaluate interventions for mitochondrial, metabolic, monogenic obesity, cardiovascular, and major depressive disorders. Encompassing Phase 2 protocols alongside observational and unclassified designs, these studies exhibit recruitment statuses ranging from not yet recruiting to withdrawn, including a Phase 2 study investigating erythrocyte-encapsulated thymidine phosphorylase for inborn errors of metabolism.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03866954 Withdrawn
Mitochondrial Diseases|Metabolic Disease|Inborn Errors of Metabolism
St George''s University of London|Neovii Biotech
2024-11 Phase 2
NCT06380426 Not yet recruiting
Monogenic Obesity
Assistance Publique - Hôpitaux de Paris
2024-07-01 --
NCT06391723 Not yet recruiting
Major Depressive Disorder
Centre Hospitalier du Rouvray|University Hospital Rouen|Centre Hospitalier Sainte Anne Paris
2024-06 Not Applicable
NCT06393829 Not yet recruiting
Cardiovascular Diseases
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal|Jewish General Hospital
2024-06-01 Not Applicable

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

Check the 2’-deoxyuridine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a natural pyrimidine nucleoside, 2’-deoxyuridine interacts with thymidine kinase within nucleoside salvage pathways, where its halogenated or modified derivatives inhibit downstream nucleic acid biochemistry and induce DNA replication stress. This disruption of genomic replication leads to cell cycle arrest and impaired cellular proliferation, providing functional relevance to metabolic and mitochondrial disease states where pyrimidine imbalance affects DNA maintenance.

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.