2'-Deoxy-5-Fluorocytidine Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Several clinical trials evaluate 2'-Deoxy-5-Fluorocytidine across diverse conditions, including Lynch syndrome, uterine corpus carcinoma, contrast-induced nephropathy, mitral valve regurgitation, and clavicle fractures. Classified under Early Phase 1, Not Applicable, or unassigned phases, these studies are currently reported as not yet recruiting, suspended, or withdrawn. Prominent research consortia and academic medical centers—including the National Cancer Institute, Gynecologic Oncology Group, and Karolinska Institutet—sponsor this early-stage and non-interventional clinical portfolio.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01199250	Not yet recruiting	Lynch Syndrome\|Recurrent Uterine Corpus Carcinoma\|Stage I Uterine Corpus Cancer\|Stage II Uterine Corpus Cancer\|Stage III Uterine Corpus Cancer\|Stage IV Uterine Corpus Cancer	Gynecologic Oncology Group\|National Cancer Institute (NCI)\|GOG Foundation	2100-01	--
NCT04598516	Withdrawn	Acute Kidney Injury (Nontraumatic)\|Contrast-induced Nephropathy\|Renal Insufficiency	Maastricht University Medical Center	2097-11-01	--
NCT05454306	Suspended	Clavicle Fracture	University of Minnesota	2028-01-09	Not Applicable
NCT04795856	Not yet recruiting	Mitral Valve Regurgitation	University of Alabama at Birmingham	2027-06-18	Early Phase 1
NCT06359262	Not yet recruiting	Mental Health Wellness 1	Karolinska Institutet	2027-01-01	Not Applicable

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

Check the 2'-Deoxy-5-Fluorocytidine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a pyrimidine analog, 2'-deoxy-5-fluorocytidine incorporates into cellular DNA to covalently bind and inhibit DNA methyltransferase (DNMT), thereby suppressing DNA methylation and reversing aberrant epigenetic gene silencing. This enzymatic blockade restores the expression of critical tumor suppressor genes to induce cell cycle arrest and apoptosis, mitigating malignant cell proliferation in clinical indications such as solid tumors and uterine corpus carcinoma.

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>).