Fluspirilene Clinical Trials

Size	Price	Qty
5mg	USD 179
25mg	USD 537

Clinical Trials

Multiple clinical trials sponsored by academic institutions, such as Hannover Medical School and the Technical University of Munich, have evaluated fluspirilene for psychiatric and neurological conditions, including schizophrenia, schizoaffective disorders, dementia, depression, and anxiety disorders. Encompassing Phase III and Phase IV designs, these investigations focused on relapse prevention during long-term antipsychotic therapy as well as drug safety in elderly patients. Recruitment outcomes across these evaluations include both completed and terminated statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02374567	TERMINATED	Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders	Hannover Medical School	2015-01	PHASE3
NCT02307396	COMPLETED	Schizophrenia; Schizophrenia and Disorders With Psychotic Features; Schizoaffective Disorders	Technical University of Munich	2015-02-01	PHASE4

(data from https://clinicaltrials.gov, updated on 2018-02-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fluspirilene functions as a non-competitive antagonist of L-type calcium channels, suppressing calcium ion influx into excitable cells and modulating downstream neuronal signaling pathways. This biochemical blockade diminishes cellular hyperexcitability, providing therapeutic efficacy in managing psychiatric disorders such as schizophrenia and schizoaffective 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>).