D-Lin-MC3-DMA (MC3) Clinical Trials

Size	Price	Qty
5mg	USD 259
25mg	USD 697

Clinical Trials

Multiple clinical trials without formal phase designations investigate conditions including moral injury, functional tricuspid regurgitation, and obesity alongside healthy volunteers. Sponsored by academic and government institutions—including the Central Arkansas Veterans Healthcare System, Minia University, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development—these protocols exhibit recruiting, completed, and terminated recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07579143	RECRUITING	Moral Injury	Central Arkansas Veterans Healthcare System	2025-04-14

(data from https://clinicaltrials.gov, updated on 2026-05-11)

Check the D-Lin-MC3-DMA (MC3) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

D-Lin-MC3-DMA is an ionizable cationic lipid that electrostatically complexes with small interfering RNA to form lipid nanoparticles, facilitating cell membrane fusion and endosomal escape into the cytoplasm. By enabling efficient target mRNA cleavage and subsequent post-transcriptional gene silencing, this lipid carrier suppresses pathogenic protein translation to modulate aberrant metabolic processes in studied therapeutic conditions such as obesity.

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>).