Fialuridine Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 290

Clinical Trials

Several clinical trials have evaluated radiolabeled diagnostic imaging and therapeutic fialuridine across infectious and oncological indications, including prosthetic joint and diabetic foot infections, viral thymidine kinase activity in lymphoma and gastric cancer, and drug tolerance in hepatitis B, herpes simplex, and HIV. Spanning Phase 1, Phase 2, and non-applicable phase classifications, these completed and terminated studies were sponsored by BioMed Valley Discoveries Inc, the National Institute of Allergy and Infectious Diseases, and the Sidney Kimmel Comprehensive Cancer Center with the National Cancer Institute.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01764919	Terminated	Diabetic Foot Infection	BioMed Valley Discoveries Inc	2013-04	Phase 2
NCT01705496	Terminated	Prosthetic Joint Infections	BioMed Valley Discoveries Inc	2012-08	Phase 2
NCT01337466	Completed	Prosthesis Related Infections	BioMed Valley Discoveries Inc	2010-12	Phase 1
NCT00982449	Completed	Hodgkin Lymphoma\|Non Hodgkin Lymphoma\|Kaposi''s Sarcoma\|Gastric Cancer\|Nasopharyngeal Cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins\|National Cancer Institute (NCI)	2010-12	Not Applicable
NCT00000654	COMPLETED	Herpes Simplex; HIV Infections; Hepatitis B	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fialuridine acts as a synthetic nucleoside analog that target-binds and undergoes phosphorylation by viral and cellular thymidine kinases, subsequently inhibiting viral DNA polymerase and disrupting nucleic acid chain elongation. This blockage of viral DNA synthesis impairs microbial replication and cellular proliferation, rendering the compound clinically relevant as an antiviral agent against hepatitis B and herpes simplex as well as a diagnostic tracer in imaging studies for prosthetic joint infections and virus-associated 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>).