Trifluoperazine Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials evaluate trifluoperazine across indications such as schizophrenia, functional dyspepsia, Diamond Blackfan anemia, and pure red cell aplasia. Spanning Phase 1 through Phase 4, these studies encompass completed, actively recruiting, and terminated protocols assessing safety and therapeutic combination strategies. Sponsorship is provided by medical centers, academic researchers, and pharmaceutical entities, including Janssen Scientific Affairs.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trifluoperazine acts as a potent inhibitor of dopamine D2 receptors with an IC50 value of 1.2 nM while also inhibiting calmodulin, thereby blocking downstream central dopaminergic signaling and calcium-dependent cellular pathways. This inhibition suppresses hyperactive dopaminergic signal transduction in neural networks, mediating the therapeutic response required for managing clinical conditions such as schizophrenia and other trial-studied indications including functional dyspepsia and hematologic 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>).