Clinical Trials

Multiple clinical trials evaluate perphenazine across Phase 1 to Phase 4 research, predominantly targeting schizophrenia, co-morbid cocaine dependence, acute ischemic stroke, dementia, and mood disorders. Sponsored by academic, government, and industry entities—including the National Institute of Mental Health, Maastricht University, and BioLineRx—these studies encompass completed evaluations of comparative antipsychotic therapies alongside protocols listed as terminated, withdrawn, or of unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04606264 COMPLETED
Perioperative Optimization
Jennifer Holder-Murray
2023-05-15 PHASE3
NCT05762146 UNKNOWN
Ischemic Stroke, Acute
Maastricht University
2022-09-05 PHASE2
NCT03510325 COMPLETED
Schizophrenia
Shanghai Mental Health Center
2019-02-12 PHASE3
NCT04776499 COMPLETED
Drug Drug Interaction; Safety Issues
Maastricht University
2021-03-18 PHASE1
NCT02431702 COMPLETED
Schizophrenia; Psychotic Disorders
Janssen Scientific Affairs, LLC
2015-07-08 PHASE3
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
2015-01 PHASE3
NCT03019887 COMPLETED
Schizophrenia Relapse
Juntendo University
2011-04
NCT02307396 COMPLETED
Schizophrenia; Schizophrenia and Disorders With Psychotic Features; Schizoaffective Disorders
Technical University of Munich
2015-02-01 PHASE4
NCT02199743 COMPLETED
Schizophrenia; Schizoaffective Disorder
University of Texas Southwestern Medical Center
2013-02 PHASE4
NCT00806234 COMPLETED
Psychotic Disorders
Johns Hopkins University
2009-01 PHASE4
NCT01157351 COMPLETED
Schizophrenia
Janssen Scientific Affairs, LLC
2010-05 PHASE4
NCT00737256 UNKNOWN
Schizophrenia; Cocaine Dependence
Paul Saenger
2008-08 PHASE2
NCT01193166 WITHDRAWN
Schizophrenia
Ortho-McNeil Janssen Scientific Affairs, LLC
2010-08 PHASE4
NCT00802100 COMPLETED
Schizophrenia
National Institute of Mental Health (NIMH)
2008-12 PHASE4
NCT00493233 COMPLETED
Schizophrenia
Centre for Addiction and Mental Health
2006-11
NCT00737256 Unknown status
Schizophrenia|Cocaine Dependence
Paul Saenger|Denver Research Institute
2008-08 Phase 2
NCT00009204 COMPLETED
Dementia; Alzheimer Disease; Dementia, Vascular
Bruce Pollock
1995-09 PHASE3
NCT00480246 COMPLETED
Healthy
BioLineRx, Ltd.
2007-05 PHASE1
NCT00014001 COMPLETED
Schizophrenia
National Institute of Mental Health (NIMH)
2000-12 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-05-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Perphenazine functions as a phenothiazine derivative that selectively binds to and antagonizes postsynaptic dopamine D2 receptors, thereby inhibiting dopamine-mediated cAMP accumulation and intracellular signal transduction. This attenuation of central dopaminergic signaling reduces hyperactive mesolimbic neurotransmission, underlying its therapeutic efficacy observed in clinical trials for schizophrenia and associated psychiatric 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>).

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