DOTAP chloride Clinical Trials

Size	Price	Qty
25mg	USD 157

Clinical Trials

A clinical trial evaluated DOTAP chloride as a liposomal gene delivery vehicle in patients with advanced non-small cell lung cancer. Jointly sponsored by academic and governmental organizations—specifically the M.D. Anderson Cancer Center and the National Cancer Institute—this completed Phase 1 study investigated an intravenously administered DOTAP and cholesterol lipid complex carrying therapeutic nucleic acids. Overall, the study highlighted the clinical feasibility and safety profile of cationic lipid-based formulations for thoracic malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00059605	Completed	Lung Cancer	M.D. Anderson Cancer Center\|National Cancer Institute (NCI)	2003-03	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

DOTAP chloride electrostatically complexes with negatively charged nucleic acids and cell membrane phospholipids, facilitating liposomal entry and efficient intracellular cargo delivery. By promoting cellular uptake and stimulating innate immune signaling, this cationic lipid system enables effective therapeutic gene transfection to suppress cell proliferation in lung cancer.

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>).