Clinical Trials

Multiple clinical trials evaluate fluphenazine dihydrochloride across Phase 1 through Phase 4, predominantly focusing on schizophrenia, schizoaffective disorders, and anxiety, alongside exploratory studies in psoriasis, dermatological conditions, pathological gambling, and multiple myeloma. Sponsored by academic research centers, government institutes, and pharmaceutical entities, these trials are primarily completed, with select studies designated as terminated or unknown.

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
NCT02203786 COMPLETED
Pathological Gambling
Centre for Addiction and Mental Health
 2009-09 PHASE2
NCT00929578 COMPLETED
Psoriasis
Tufts Medical Center
 2008-11 PHASE2
NCT00821301 UNKNOWN
Multiple Myeloma
Immune Control
 2008-12 PHASE1
NCT00335647 COMPLETED
Multiple Myeloma and Plasma Cell Neoplasm
Immune Control
 2006-01 PHASE1; PHASE2
NCT00356200 TERMINATED
Psoriasis
Tufts Medical Center
 2006-07 PHASE2
NCT00161018 COMPLETED
Schizophrenia
University of Maryland, Baltimore
 2003-11 PHASE3
NCT00014001 COMPLETED
Schizophrenia
National Institute of Mental Health (NIMH)
 2000-12 PHASE4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fluphenazine dihydrochloride acts as a phenothiazine-class antagonist that binds to dopamine D1 and D2 receptors as well as histamine H1 receptors, thereby inhibiting downstream dopaminergic G-protein-coupled signaling pathways. This receptor blockade suppresses hyperactive neuronal firing and cellular neurotransmission, providing the mechanistic basis for attenuating psychotic symptoms in clinical trial conditions 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>).

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Note: Technical data last updated: Sep 1, 2026.