Diphenylterazine (DTZ) Clinical Trials

Size	Price	Qty
5mg	USD 370
25mg	USD 970

Clinical Trials

A clinical trial evaluated this compound for therapeutic applications in multiple myeloma. This completed, international, multicenter, open-label Phase II study was sponsored by a consortium of major medical institutions to evaluate treatment efficacy in clinical populations. Overall, this mid-phase investigation provides key clinical evidence regarding therapeutic protocols for managing multiple myeloma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00263484	Completed	Multiple Myeloma	Gleneagles Hospital\|Singapore General Hospital\|National Cancer Centre Singapore\|Tan Tock Seng Hospital\|Seoul National University Hospital\|Asan Medical Center\|Samsung Medical Center\|Chonnam National University Hospital\|Christian Medical College Vellore India\|Tata Memorial Hospital	2005-12	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diphenylterazine (DTZ) acts as a synthetic coelenterazine-analog substrate that selectively reacts with luciferase enzymes, driving oxidative bioluminescence with minimal background emission. This enzymatic light generation enables high-sensitivity optical detection and non-invasive tracking of cell populations, facilitating the quantitative monitoring of tumor progression and treatment response in conditions such as multiple myeloma.

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>).