Guanabenz Acetate Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

A Phase I clinical trial evaluated oral guanabenz in patients with relapsing-remitting multiple sclerosis. Sponsored by governmental health organizations, specifically the National Institute of Neurological Disorders and Stroke alongside the National Institutes of Health Clinical Center, this early-stage study was formally terminated. Consequently, the clinical development of guanabenz for this neurological indication remains limited and early-stage.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02423083	Terminated	Multiple Sclerosis Relapsing-Remitting\|Multiple Sclerosis	National Institute of Neurological Disorders and Stroke (NINDS)\|National Institutes of Health Clinical Center (CC)	2015-04-21	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Guanabenz acetate acts as a selective agonist of α2A-, α2B-, and α2C-adrenergic receptors, preferentially binding the α2A subtype with high potency to activate downstream G protein-coupled signaling cascades. This receptor activation suppresses central sympathetic outflow and regulates neuroprotective stress responses, providing the mechanistic rationale for its clinical evaluation in neurological conditions such as multiple sclerosis.

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>).