Dinotefuran Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

A clinical trial evaluating dinotefuran is currently active and recruiting to assess public health vector control for malaria prevention. Operating without a standard clinical phase assignment, this community-based study is sponsored by a collaborative consortium of academic, governmental, and international health organizations. Ultimately, the research aims to establish the efficacy, acceptability, and cost-effectiveness of dinotefuran-based vector control strategies in endemic regions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05219565	Recruiting	Malaria	Liverpool School of Tropical Medicine\|Kenya Medical Research Institute\|Centers for Disease Control and Prevention\|PATH\|Kenya Ministry of Health	2022-03-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dinotefuran functions as a neonicotinoid agonist that selectively binds to insect nicotinic acetylcholine receptors (nAChRs), inducing persistent overstimulation of cholinergic neurotransmission. This continuous receptor activation causes hyperactivation and severe neurotoxicity in target vector mosquitoes, providing an effective mechanism to interrupt vector life cycles and control malaria transmission.

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>).