Dihydroethidium Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 417

Clinical Trials

Several clinical trials sponsored by academic and regional health institutes, including the Hospital Universitario Dr. Jose E. Gonzalez and the Luxembourg Institute of Health, are evaluating therapeutic applications for chronic myeloid leukemia in the chronic phase and osteoarthritis. This landscape encompasses a Phase 2 trial investigating metabolic cytochrome P450 inhibition to optimize target therapy dosing and a study with a phase designation of Not Applicable assessing mobile-based physical activity interventions. The studies currently hold recruitment statuses reported as recruiting and not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05638763	Recruiting	Chronic Myeloid Leukemia Chronic Phase	Hospital Universitario Dr. Jose E. Gonzalez\|Fernando De la Garza Salazar	2024-11	Phase 2
NCT06385028	Not yet recruiting	Osteoarthritis	Luxembourg Institute of Health\|Œuvre Nationale de Secours Grande Duchesse Charlotte	2024-10-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dihydroethidium is a cell-permeable fluorogenic probe that selectively reacts with intracellular superoxide radical anions, undergoing oxidation to form ethidium derivatives that intercalate into cellular nucleic acids. This fluorescence-generating reaction enables precise fluorometric quantification of reactive oxygen species, providing a key analytical method to evaluate redox imbalance and oxidative stress mechanisms in conditions such as chronic myeloid leukemia and osteoarthritis.

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>).