4-Nitroquinoline 1-oxide Clinical Trials

Size	Price	Qty
100mg	USD 147
1g	USD 319

Clinical Trials

Multiple clinical trials evaluate 4-Nitroquinoline 1-oxide across indications including heart failure, advanced solid tumors, non-Hodgkin's lymphoma, and precancerous conditions. Ranging from Phase 1 safety and pharmacokinetic evaluations to observational studies, these trials are sponsored by pharmaceutical companies like GlaxoSmithKline and Spectrum Pharmaceuticals Inc., as well as institutional entities including Massachusetts General Hospital and the National Cancer Institute. The overall recruitment status across these recorded studies includes both completed and terminated trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05044325	Terminated	Heart Failure	GlaxoSmithKline	2021-09-20	Phase 1
NCT00558727	Terminated	Advanced Solid Tumors\|Non-Hodgkin''s Lymphoma	Spectrum Pharmaceuticals Inc	2007-11	Phase 1
NCT00445653	Completed	Precancerous Condition	Massachusetts General Hospital\|National Cancer Institute (NCI)	2005-08	--

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

Check the 4-Nitroquinoline 1-oxide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

4-Nitroquinoline 1-oxide undergoes enzymatic reduction to generate reactive intracellular metabolites that covalently bind purine bases in DNA, forming bulky adducts that disrupt replication and transcription fidelity. The resulting genomic instability triggers oxidative stress, cellular mutagenesis, and apoptosis, which mediates its role as a model carcinogen relevant to studies of precancerous conditions and advanced solid tumors.

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>).