Volinanserin Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

Multiple clinical trials sponsored by Sanofi have evaluated volinanserin in Phase 3 studies to assess its safety and efficacy in patients with sleep initiation and maintenance disorders. While several clinical trials were successfully completed after evaluating parameters of sleep maintenance insomnia, others were terminated prior to full completion. Together, these investigations establish the late-stage clinical landscape for volinanserin in managing sleep disturbance conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00464061	TERMINATED	Sleep Initiation and Maintenance Disorders	Sanofi	2007-04	PHASE3
NCT00788515	TERMINATED	Sleep Initiation and Maintenance Disorders	Sanofi	2008-11	PHASE3
NCT00495885	COMPLETED	Sleep Initiation and Maintenance Disorders	Sanofi	2007-06	PHASE3
NCT00464243	COMPLETED	Sleep Initiation and Maintenance Disorders	Sanofi	2007-04	PHASE3

(data from https://clinicaltrials.gov, updated on 2016-05-26)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Volinanserin selectively binds to the 5-HT2 receptor with high affinity (Ki = 0.36 nM), blocking serotonin-mediated downstream signal transduction and suppressing hyperactive neuronal firing in the central nervous system. This pathway inhibition attenuates serotonergic arousal mechanisms, providing a mechanistic basis for its therapeutic evaluation in sleep initiation and maintenance disorders.

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>).