Dihydrouracil Clinical Trials

Size	Price	Qty
10mg	USD 70

Clinical Trials

A clinical trial sponsored by an academic research organization, The Netherlands Cancer Institute, evaluates dihydrouracil within the context of drug safety biomarkers. This non-interventional study specifically examines how food consumption impacts systemic levels of uracil and dihydrouracil to evaluate dihydropyrimidine dehydrogenase enzymatic activity. Lacking a formal clinical phase designation, the trial currently maintains an unknown recruitment status in official registries.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02718664	Unknown status	Drug Safety Biomarkers	The Netherlands Cancer Institute	2016-04	Not Applicable

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

Check the Dihydrouracil 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 pyrimidine catabolite, dihydrouracil is generated via the enzymatic reduction of uracil by dihydropyrimidine dehydrogenase, serving as a critical intermediate in downstream pyrimidine degradation pathways and cellular nucleic acid turnover. Quantifying circulating levels of dihydrouracil provides a direct measure of dihydropyrimidine dehydrogenase activity, establishing its clinical utility as a drug safety biomarker to assess patient susceptibility to fluoropyrimidine-induced toxicity.

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>).