Clinical Trials

Several clinical trials evaluate the clinical utility, pharmacokinetics, and safety profile of chlorprothixene for conditions including morbid obesity, dementia, depression, schizophrenia, psychosomatic disorders, and anxiety disorders. Ranging from Phase 3 to unspecified phases, these studies are primarily sponsored by academic institutions and medical centers such as the Norwegian University of Science and Technology and Hannover Medical School. Recruitment statuses span from active to terminated, examining topics such as post-bariatric surgery pharmacokinetics and gerontopsychiatric pharmacovigilance.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03449485 Recruiting
Obesity Morbid
Norwegian University of Science and Technology|St. Olavs Hospital|Volvat Medisinsk Senter Stokkan|Namsos Hospital|Alesund Hospital
 2018-01-02 --
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chlorprothixene functions as a high-affinity antagonist across dopamine, serotonin, and histamine receptors, blocking G-protein-coupled receptor signal transduction to attenuate postsynaptic neuronal signaling. This neurotransmitter modulation reduces central nervous system hyperexcitability, providing the mechanistic basis for its therapeutic utility in managing conditions investigated in clinical trials, such as schizophrenia, depression, and anxiety 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.