Dimethindene maleate Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials sponsored solely by Novartis have evaluated dimethindene maleate across Phase 1, Phase 2, and Phase 3 studies. These investigations targeted diverse conditions, including cardiovascular parameters such as heart rate, blood pressure, and arrhythmias, as well as upper respiratory tract infection symptoms including nasal congestion, rhinorrhea, and sneezing. Trial statuses ranged from an early-phase safety study that was withdrawn prior to completion to a Phase 3 study that successfully achieved completed status while evaluating symptomatic relief for upper respiratory conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01448057	COMPLETED	Upper Respiratory Tract Infection; Nasal Congestion; Rhinorrhea; Sneezing	Novartis	2013-07	PHASE3
NCT01026961	WITHDRAWN	Heart Rate; Blood Pressure; Arrhythmias	Novartis	2010-09	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2017-03-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dimethindene maleate acts as a selective histamine H1 receptor antagonist that reversibly suppresses cromakalim-induced, glibenclamide-sensitive potassium currents, thereby blocking downstream histaminergic signaling and reducing vascular permeability and smooth muscle hyperreactivity. By attenuating these histamine-mediated pro-inflammatory pathways, the compound reduces local mucosal edema and hypersecretion, providing clinical relevance in alleviating upper respiratory tract infection symptoms such as nasal congestion, rhinorrhea, and sneezing.

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>).