Vanoxerine dihydrochloride Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials sponsored by institutional and pharmaceutical entities, including the National Institute on Drug Abuse and Laguna Pharmaceuticals, Inc., have evaluated Vanoxerine for cardiovascular and central nervous system indications across Phase I through Phase III. An early Phase I safety trial for cocaine-related disorders was terminated, whereas a Phase II trial successfully completed evaluating single oral doses to convert symptomatic atrial fibrillation and atrial flutter. However, a larger Phase III trial assessing sinus rhythm restoration in patients with atrial fibrillation or flutter was subsequently terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02454283	TERMINATED	Atrial Fibrillation or Flutter	Laguna Pharmaceuticals, Inc.	2015-09	PHASE3
NCT01691313	COMPLETED	Symptomatic Atrial Fibrillation; Atrial Flutter	Laguna Pharmaceuticals, Inc.	2012-11	PHASE2
NCT00218049	TERMINATED	Cocaine Abuse; Cocaine-Related Disorders	National Institute on Drug Abuse (NIDA)	2004-12	PHASE1

(data from https://clinicaltrials.gov, updated on 2016-10-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vanoxerine dihydrochloride functions as a potent and selective inhibitor of the presynaptic dopamine reuptake complex, binding the transporter to block dopamine reabsorption and consequently elevating synaptic dopamine concentrations. This sustained neurotransmitter elevation and concurrent cardiac ion channel modulation inhibit aberrant neuronal and cardiac signaling pathways, providing the rationale for its clinical investigation in cocaine-related disorders and atrial fibrillation or flutter.

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>).