Clinical Trials

Chlorpromazine has been evaluated across numerous clinical trials spanning Phase 1 through Phase 4 alongside non-applicable designs, with statuses ranging from active recruitment to completion or termination. Sponsored by academic institutions such as Harvard Medical School and Melbourne Health, hospital networks, and research foundations, these studies investigate diverse psychiatric, neurological, and oncologic conditions. Research primarily focuses on schizophrenia, bipolar disorder, and acute agitation, while also addressing glioblastoma multiforme and substance dependence.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05431595 RECRUITING
Delirium; Epileptics; Neuroleptics
M.D. Anderson Cancer Center
 2022-07-19 PHASE2; PHASE3
NCT07364344 NOT_YET_RECRUITING
Acute Ischemic Stroke
Ji Xunming,MD,PhD
 2026-01
NCT06663631 RECRUITING
Acute Ischemic Stroke
Capital Medical University
 2024-11-09 PHASE1
NCT06238089 Recruiting
Intellectual Disability
University of Plymouth|Peninsula Clinical Trials Unit
 2023-12-19 --
NCT05190315 COMPLETED
Glioblastoma Multiforme
Mohammed Milhem
 2022-01-28 PHASE1
NCT05433402 WITHDRAWN
Colon Cancer Stage III
Sadat City University
 2022-07-20 PHASE1; PHASE2
NCT05206747 Recruiting
Mania|Sleep|Bipolar Disorder
Ottawa Hospital Research Institute
 2022-09-07 Not Applicable
NCT04224441 UNKNOWN
Glioblastoma Multiforme; MGMT-Unmethylated Glioblastoma
Marco G Paggi, MD, PhD
 2019-12-15 PHASE2
NCT03021486 ACTIVE_NOT_RECRUITING
Advanced Malignant Neoplasm; Delirium; Locally Advanced Malignant Neoplasm; Metastatic Malignant Neoplasm; Recurrent Malignant Neoplasm
M.D. Anderson Cancer Center
 2017-06-05 PHASE2; PHASE3
NCT04354805 UNKNOWN
COVID-19
Cairo University
 2020-08-01 PHASE2; PHASE3
NCT04366739 WITHDRAWN
COVID-19
Centre Hospitalier St Anne
 2020-04-29 PHASE3
NCT03639558 COMPLETED
Psychiatric Emergency; Aggression; Agitation
Joseph Dib
 2018-08-28 PHASE4
NCT06154434 COMPLETED
Healthy Subject
Whanin Pharmaceutical Company
 2018-12-06 PHASE1
NCT03548714 Completed
Alcohol Dependence|Alcohol Interaction
Pop Test Oncology LLC|Pharmacotherapies for Alcohol and Substance Use Disorders Alliance|Congressionally Directed Medical Research Programs|Michael E. DeBakey VA Medical Center|Baylor College of Medicine|University of California San Diego
 2018-09-01 Phase 1
NCT03183310 UNKNOWN
Esophageal Reflux
Universitaire Ziekenhuizen KU Leuven
 2017-07-01
NCT02943213 COMPLETED
Anti-Psychotic; Management of Manifestations of Psychotic Disorders; Treatment of Schizophrenia; Control Nausea and Vomiting; Relief of Restlessness and Apprehension Before Surgery; Acute Intermittent Porphyria; Adjunct in the Treatment of Tetanus; Control Manifestations of the Manic Type of Mani-depressive Illness; Relief of Intractable Hiccups
Cycle Pharmaceuticals Ltd.
 2016-11 PHASE1
NCT00202293 COMPLETED
Bipolar Disorder; Schizoaffective Disorder
Melbourne Health
 2001-10-01 PHASE4
NCT01404364 COMPLETED
Blind Painful Eye; Refractory Glaucoma; Control of Pain Through Drug Injection
Hospital Governador Celso Ramos
 2010-01
NCT00882518 COMPLETED
Schizophrenia
AstraZeneca
 2009-04 PHASE3
NCT00654576 COMPLETED
Schizophrenia
Central South University
 2005-02 PHASE4
NCT02810782 COMPLETED
Neonatal Abstinence Syndrome
University of Zurich
 2001-06 PHASE3
NCT00169039 TERMINATED
Schizophrenia
Harvard Medical School (HMS and HSDM)
 1994-12 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-11-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chlorpromazine acts as a dopamine receptor antagonist and potassium channel inhibitor, binding to dopamine receptors and inward-rectifying potassium channels to disrupt transmembrane ion flux and intracellular signaling pathways. This blockade modulates neuronal membrane potential and attenuates central dopaminergic neurotransmission, providing therapeutic efficacy in clinical trial conditions such as schizophrenia, bipolar disorder, and acute agitation.

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.