Clinical Trials

Several clinical trials evaluate hematoxylin for histological diagnostic methods, tissue staining, and pathological modeling in conditions including chronic dacryocystitis, actinic keratoses, upper tract urothelial carcinoma, colorectal neoplasms, primary aldosteronism, and central nervous system tumors. Sponsored predominantly by academic and university institutions, these studies primarily utilize observational and diagnostic designs, resulting in unassigned or non-applicable trial phases. Across these protocols, recruitment statuses range from active and recruiting to completed or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04793230 Completed
Dacryocystitis; Chronic
Al-Azhar University
 2019-01-01 --
NCT03483935 Completed
Actinic Keratoses|Precancerous Skin Lesion
University of Dundee|Emblation Limited
 2018-03-07 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hematoxylin oxidizes to haematein and coordinates with trivalent metal ions such as aluminum(III) or iron(III) to form positively charged dye-metal complexes that selectively bind negatively charged nucleic acids within cell nuclei, resulting in intense basophilic chromatin staining. This nuclear labeling enables detailed histopathology and microscopic evaluation of cellular morphology, facilitating diagnostic classification and microenvironment profiling across clinical studies investigating central nervous system neoplasms, colorectal carcinomas, and upper tract urothelial 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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.