Clinical Trials

The clinical landscape evaluating Alizarin is currently limited to a completed clinical trial sponsored by an academic hospital center, Nationwide Children's Hospital. With no designated phase, this study evaluated qualitative sweat distribution patterns in pediatric patients diagnosed with postural tachycardia syndrome, syncope, and anxiety. Overall, clinical research regarding Alizarin remains sparse and focused on physiological parameters associated with these specific autonomic and psychological conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02329548 COMPLETED
Postural Tachycardia Syndrome; Syncope; Anxiety
Nationwide Children's Hospital
2014-12

(data from https://clinicaltrials.gov, updated on 2017-01-31)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alizarin selectively binds to and inhibits the cytochrome P450 enzymes CYP1A1, CYP1A2, and CYP1B1, thereby blocking downstream xenobiotic clearance and altering cellular detoxification dynamics. This targeted enzymatic inhibition and aryl hydrocarbon receptor modulation alter systemic metabolic homeostasis, providing clinical relevance in the assessment of physiological dysregulation in postural tachycardia syndrome, syncope, and anxiety.

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>).

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