Clinical Trials

A clinical trial has evaluated the physiological effects of 1400W 2HCl, specifically investigating endothelial dysfunction associated with the cardiovascular impacts of air pollution exposure. This completed study did not specify a formal trial phase and was sponsored by academic and public health entities, including the University of Edinburgh, NHS Lothian, and Umeå University. Overall, clinical evaluation of this compound remains limited to specific exploratory studies regarding vascular and endothelial function.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00845169 Completed
Endothelial Dysfunction
University of Edinburgh|NHS Lothian|Umeå University
2012-04 Not Applicable

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

Check the 1400W 2HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

1400W 2HCl acts as a slow, tight-binding, and highly selective inhibitor of inducible nitric-oxide synthase (iNOS), blocking enzymatic activity and preventing downstream overproduction of nitric oxide. By suppressing excessive iNOS-mediated signaling and cellular oxidative stress, this targeted inhibition helps maintain vascular homeostasis, which is directly relevant to mitigating endothelial dysfunction evaluated in clinical trials.

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.