Idoxuridine Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Multiple clinical trials sponsored by academic and federal organizations—including the National Cancer Institute, the NIH Clinical Center, and Rush University Medical Center—have evaluated idoxuridine regimens for advanced solid neoplasms, lymphoma, and leukemia. These Phase 1 and Phase 2 studies vary in status: a clinical trial investigating safety, absorption, and metabolism in solid tumors and lymphomas was completed, whereas a clinical trial targeting acute leukemia was withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01240577	Completed	Neoplasms\|Lymphoma	National Cancer Institute (NCI)\|National Institutes of Health Clinical Center (CC)	2010-10-26	Phase 1
NCT00003405	WITHDRAWN	Leukemia	Rush University Medical Center	1998-04	PHASE2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Idoxuridine functions as a nucleoside analog that incorporates into replicating DNA, thereby inhibiting DNA polymerase activity and disrupting nucleic acid synthesis. This disruption impairs cell division and induces cytotoxicity, providing the mechanistic basis for evaluating its therapeutic efficacy in clinical trials targeting neoplasms such as lymphoma and 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>).