Atipamezole hydrochloride Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Multiple Phase 1 clinical trials sponsored by academic institutions have evaluated the pharmacological effects and therapeutic potential of atipamezole hydrochloride. A completed study by the University of Turku analyzed striatal receptor binding competition between atipamezole and endogenous noradrenaline in healthy volunteers using positron emission tomography. Conversely, an investigation by the University of Chicago aimed to evaluate the rapid reversal of dexmedetomidine sedation during emergence from anesthesia, but the study was ultimately withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04942340	WITHDRAWN	Emergence From Anesthesia	University of Chicago	2023-05	PHASE1
NCT01435213	COMPLETED	Healthy	University of Turku	2011-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2023-05-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Atipamezole hydrochloride selectively binds to central and peripheral alpha-2 adrenergic receptors, potently blocking presynaptic and postsynaptic receptor activation to prevent downstream inhibitory G-protein signaling and enhance noradrenaline release. This elevated noradrenergic transmission drives central nervous system excitation and neural arousal, providing the mechanistic basis for accelerating emergence from anesthesia and restoring alertness in subjects exposed to alpha-2 adrenergic agonists.

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>).