Clinical Trials

Multiple clinical trials are currently recruiting to evaluate regimens and metabolic factors associated with uracil derivatives and fluoropyrimidine therapy. Designated as phase not applicable, these studies target advanced malignancies, including female breast neoplasms and various gastrointestinal cancers such as colorectal, esophageal, appendiceal, small bowel, and ampullary cancers. Investigations are led by academic and clinical sponsors, including Dartmouth-Hitchcock Medical Center and Centre Antoine Lacassagne in collaboration with Cerbaliance.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05780684 Recruiting
Colorectal Cancer|Esophagus Cancer|Appendix Cancer|Small Bowel Cancer|Ampullary Cancer
Dartmouth-Hitchcock Medical Center
 2023-07-14 Not Applicable
NCT04198727 Recruiting
Breast Neoplasm Malignant Female
Centre Antoine Lacassagne|Cerbaliance
 2020-07-20 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Uracil serves as an essential pyrimidine nucleobase that incorporates into RNA structure and pyrimidine metabolic pathways, where metabolic modification or analog substitution disrupts cellular nucleic acid synthesis and processing. This disruption of nucleotide incorporation halts tumor cell proliferation, providing the mechanistic foundation for fluoropyrimidine-based therapies investigated in clinical trials targeting gastrointestinal and breast malignancies.

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>).

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Note: Technical data last updated: Sep 1, 2026.