2'-Deoxyuridine 5'-monophosphate disodium salt Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

A completed Phase I open-label clinical trial sponsored by an academic institution, the University of Oxford, evaluated the safety profile, pharmacokinetics, and preliminary clinical activity of a novel nucleotide derivative in patients diagnosed with cancer. As an early-phase investigation, it highlights the initial clinical translation of targeting pyrimidine nucleotide metabolic pathways for oncology treatments. Overall, clinical trial activity for this target remains concentrated in early-phase evaluation within academic clinical research settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02723240	Completed	Cancer	University of Oxford	2016-01	Phase 1

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

Check the 2'-Deoxyuridine 5'-monophosphate disodium salt product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an endogenous substrate for thymidylate synthase, 2'-deoxyuridine 5'-monophosphate binds the active site to undergo enzymatic conversion into deoxythymidine monophosphate, providing essential pyrimidine precursors required for DNA replication. Disruption of this methylation step depletes deoxythymidine monophosphate pools and halts DNA synthesis, leading to cell cycle arrest and providing a therapeutic rationale for suppressing tumor proliferation in cancer.

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>).