Clinical Trials

A Phase IV clinical trial, sponsored by the Baker Heart and Diabetes Institute, investigates the effects of moxonidine combined with dietary intervention on cardiac, renal, and vascular endothelial function. The study targets young individuals with overweight, obesity, and abdominal obesity, with a recruitment status currently listed as unknown. Overall, this research focuses on evaluating the cardiovascular and metabolic impact of moxonidine in these populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01180231 Unknown status
Obesity|Overweight
Baker Heart and Diabetes Institute
2010-09 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Moxonidine selectively binds to and activates the imidazoline receptor subtype 1, leading to a reduction in central sympathetic nervous system outflow and decreased circulating catecholamine levels. This central signaling inhibition reduces systemic vascular resistance and arterial blood pressure, which helps maintain vascular endothelial and renal function in conditions such as obesity and hypertension.

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.