Trifluoperazine 2HCl Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Several clinical trials evaluate the therapeutic potential of trifluoperazine across neuropsychiatric, gastrointestinal, and hematologic conditions, spanning Phase 1 through Phase 4 investigations sponsored by academic psychiatric hospitals, independent medical researchers, and industry sponsors such as Janssen Scientific Affairs. Completed trials have evaluated trifluoperazine as a primary or adjunctive treatment for schizophrenia. Additionally, active recruitment is ongoing for a Phase 2/3 trial targeting functional dyspepsia, whereas a Phase 1/2 study assessing red blood cell transfusion-dependent Diamond Blackfan anemia and pure red cell aplasia was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07008235	RECRUITING	Functional Dyspepsia	Md. Moktadirul Hoque Shuvo	2025-07-01	PHASE2; PHASE3
NCT03966053	TERMINATED	Diamond Blackfan Anemia; Pure Red Cell Aplasia	Adrianna Vlachos, MD	2019-09-13	PHASE1; PHASE2
NCT02704962	COMPLETED	Schizophrenia	Kaohsiung Kai-Suan Psychiatric Hospital	2012-01	PHASE4

(data from https://clinicaltrials.gov, updated on 2026-05-07)

Check the Trifluoperazine 2HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trifluoperazine functions as a potent dopamine D2 receptor inhibitor (IC50 = 1.1 nM) and calmodulin antagonist, effectively blocking downstream dopaminergic signal transduction and calmodulin-dependent enzymatic pathways. This intracellular inhibition modulates neuronal signaling and cellular activation, providing the biological foundation for its therapeutic relevance in schizophrenia and functional dyspepsia.

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>).