Tetrazolium Red Clinical Trials

Size	Price	Qty
50mg	USD 79
250mg	USD 237

Clinical Trials

Several clinical trials evaluate conditions such as myocardial infarction, breast cancer, and advanced metastatic disease, including investigations into triphenyl tetrazolium chloride for early autopsy diagnosis and real-world observational studies in advanced breast cancer management. Sponsored by academic institutions, medical centers, and pharmaceutical organizations such as Pfizer, Blokhin's Russian Cancer Research Center, and University Hospital Montpellier, these studies feature unspecified formal phases alongside recruitment statuses ranging from completed to unknown. Together, these entries reflect the broader clinical and observational research scope recorded for this compound.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05789771	Completed	HR+/HER2- Breast Cancer\|Metastatic Disease\|Аdvanced Disease	Blokhin''s Russian Cancer Research Center\|Russian Society of Clinical Oncology	2022-04-01	--
NCT05399329	Completed	Breast Cancer	Pfizer	2022-04-20	--
NCT04924426	Unknown status	Myocardial Infarction	University Hospital Montpellier	2021-05-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tetrazolium Red functions as a cell-permeable redox indicator that is enzymatically reduced by active mitochondrial dehydrogenases into an insoluble, brightly colored red formazan precipitate within metabolically viable cells. This enzymatic turnover directly delineates viable tissue from enzyme-deficient necrotic regions, making it clinically relevant for the early histochemical diagnosis and assessment of ischemic tissue damage in acute myocardial infarction.

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>).