Thioridazine hydrochloride Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Multiple clinical trials have evaluated thioridazine across diverse indications, including acute myeloid leukemia, healthy subjects, and psychiatric conditions such as schizophrenia, anxiety, depression, and dementia. Ranging from Early Phase I through Phase IV, these investigations were sponsored by academic medical centers, collaborative groups, and industry entities. Reported recruitment statuses include completed studies, such as a Phase I trial combining thioridazine with cytarabine in acute myeloid leukemia, alongside terminated evaluations like a gerontopsychiatric pharmacovigilance study.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02374567	TERMINATED	Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders	Hannover Medical School	2015-01	PHASE3
NCT02096289	COMPLETED	Acute Myeloid Leukemia	Ontario Clinical Oncology Group (OCOG)	2014-07	PHASE1
NCT02307396	COMPLETED	Schizophrenia; Schizophrenia and Disorders With Psychotic Features; Schizoaffective Disorders	Technical University of Munich	2015-02-01	PHASE4
NCT01765803	TERMINATED	Healthy Subjects	New Mexico Cancer Research Alliance	2013-06	EARLY_PHASE1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Thioridazine functions by selectively binding to central dopamine D2 receptors, which blocks downstream G-protein-coupled signaling pathways and alters intracellular second messenger cascades. This signaling inhibition reduces neuronal hyper-excitability and suppresses leukemic stem cell viability, thereby attenuating psychotic manifestations in schizophrenia and providing therapeutic potential in acute myeloid leukemia.

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>).