Clozapine N-oxide (CNO chemical) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials sponsored by healthcare and research institutions, including the International Centre for Diarrhoeal Disease Research Bangladesh, Seattle Children's Hospital, and Fondazione Poliambulanza Istituto Ospedaliero, evaluate conditions such as pediatric malnutrition, chronic nonbacterial or recurrent multifocal osteomyelitis, respiratory distress syndrome, and preterm birth. Although these studies do not list standard interventional phases, several clinical trials focusing on pediatric nutrition and neonatal respiratory support have completed recruitment. Meanwhile, a clinical trial is currently recruiting participants for an international disease registry.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02772835	COMPLETED	Respiratory Distress Syndrome; Preterm Birth	Fondazione Poliambulanza Istituto Ospedaliero	2016-01
NCT00372242	Completed	Mild and Moderate Malnourished Children	International Centre for Diarrhoeal Disease Research Bangladesh	2000-12	Not Applicable

(data from https://clinicaltrials.gov, updated on 2018-02-27)

Check the Clozapine N-oxide (CNO chemical) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clozapine N-oxide selectively binds to and activates engineered human muscarinic designer receptors (DREADDs), triggering downstream G-protein-coupled signaling cascades to precisely regulate intracellular second messengers and cellular excitability. This targeted receptor activation modulates specific cellular physiology, offering a powerful chemogenetic tool to investigate underlying mechanisms relevant to physiological dysfunctions such as pediatric malnutrition, inflammatory bone disorders, and neonatal respiratory distress syndrome.

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>).