Maprotiline HCl Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Several clinical trials have evaluated maprotiline across diverse oncological and neuropsychiatric indications, including recurrent glioblastoma and disorders such as depression, dementia, schizophrenia, psychosomatic illness, and anxiety. Ranging from Phase I combination regimens in brain tumors to Phase III gerontopsychiatric pharmacovigilance, these studies were sponsored by academic institutions including the University of Rochester and Hannover Medical School. However, current recruitment records indicate that these clinical trials have either been withdrawn or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04200066	WITHDRAWN	Glioblastoma; Brain Tumor	University of Rochester	2022-06-01	PHASE1
NCT04200066	Withdrawn	Glioblastoma\|Brain Tumor	University of Rochester	2022-06-01	Phase 1
NCT02374567	TERMINATED	Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders	Hannover Medical School	2015-01	PHASE3

(data from https://clinicaltrials.gov, updated on 2022-08-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Maprotiline hydrochloride selectively binds to and inhibits presynaptic norepinephrine reuptake transporters, thereby preventing the reuptake of norepinephrine into presynaptic nerve terminals and enhancing synaptic adrenergic transmission. This sustained elevation of central noradrenergic signaling underpins its therapeutic efficacy in alleviating depressive neurosis and anxiety disorders, while also providing a rationale for evaluating its pharmacological effects in glioblastoma and other central nervous system 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>).