Tretazicar (CB1954) Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Several clinical trials supported by academic centers, government entities, and pharmaceutical sponsors have evaluated Tretazicar (CB1954) in oncology across Phase I and Phase II studies. These evaluations include a completed clinical trial assessing therapeutic strategies in prostate cancer and a clinical trial examining efficacy and safety in hepatocellular carcinoma that was terminated prior to completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04374240	COMPLETED	Prostate Cancer	University of Birmingham	2013-03-19	PHASE1
NCT04374240	Completed	Prostate Cancer	University of Birmingham\|Janssen LP\|Department of Health United Kingdom\|Medical Research Council	2013-03-19	Phase 1
NCT00746590	TERMINATED	Hepatocellular Carcinoma	BTG International Inc.	2008-09	PHASE2

(data from https://clinicaltrials.gov, updated on 2021-11-03)

Check the Tretazicar (CB1954) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tretazicar functions as an anticancer prodrug activated by NAD(P)H quinone oxidoreductase 2 (NQO2) in the presence of the co-substrate caricotamide, producing a cytotoxic bifunctional alkylating agent that disrupts genomic integrity and induces tumor cell death. This enzyme-targeted bioactivation mechanism provides the biological basis for inhibiting tumor growth in clinical investigations of prostate cancer and hepatocellular 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>).