BrdU (Bromodeoxyuridine, 5-BrdU) Clinical Trials

Size	Price	Qty
200mg	USD 147
500mg	USD 247

Clinical Trials

Multiple clinical trials sponsored by academic centers, university hospitals, and government organizations—such as the National Cancer Institute and the US Department of Veterans Affairs—have evaluated Bromodeoxyuridine (BrdU) across oncologic, metabolic, cardiovascular, and inflammatory indications, including prostate cancer, leukemia, colorectal cancer, asthma, obesity, and multiple sclerosis. These investigations encompass Phase 2 to Phase 4 trials alongside early or unassigned designs, with recruitment statuses spanning completed, actively recruiting, withdrawn, or unknown. Together, they reflect BrdU’s application as a diagnostic or labeling agent in cell kinetics and broader clinical protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04365205	Recruiting	Asthma	University Hospital Bordeaux	2020-09-23	--
NCT02654925	Completed	Obesity	University of Colorado Denver	2016-03	--
NCT01407211	Unknown status	Relapsing Remitting Multiple Sclerosis	Tehran University of Medical Sciences	2011-04	Phase 4
NCT01414972	Unknown status	Atherosclerosis	Tehran University of Medical Sciences	2010-05	Phase 4
NCT01225289	Completed	Relapsing Remitting Multiple Sclerosis	Tehran University of Medical Sciences	2009-10	Phase 4
NCT00042250	COMPLETED	Hematologic Malignancies	M.D. Anderson Cancer Center	1992-05
NCT00003832	COMPLETED	Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer	National Cancer Institute (NCI)	1999-07	PHASE2
NCT00003405	WITHDRAWN	Leukemia	Rush University Medical Center	1998-04	PHASE2
NCT00032344	Completed	Colorectal Cancer	US Department of Veterans Affairs\|VA Office of Research and Development	1993-10	Phase 3

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

Check the BrdU (Bromodeoxyuridine, 5-BrdU) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a synthetic thymidine analog, Bromodeoxyuridine (BrdU) competes with endogenous thymidine to incorporate directly into newly synthesized genomic DNA during the S-phase of the cell cycle. This chemical incorporation marks replicating DNA strands to facilitate the quantitative detection of proliferating cell populations, providing vital cellular kinetic data relevant to clinical studies in oncology, such as prostate cancer and leukemia, as well as inflammatory disorders.

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>).