Efonidipine Clinical Trials

Size	Price	Qty
25mg	USD 172
100mg	USD 470

Clinical Trials

A clinical trial sponsored by an academic institution, the University of Southern Denmark, evaluated the therapeutic application of efonidipine in vascular and endothelial physiology. Operating under an unassigned phase status, this completed study investigated the functional contribution of T-type calcium channels to human vascular responses. Overall, the research reflects targeted clinical inquiry into how dual calcium channel inhibition modulates endothelial and vascular health.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02885558	COMPLETED	Endothelium, Vascular	University of Southern Denmark	2017-11-01

(data from https://clinicaltrials.gov, updated on 2021-06-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Efonidipine acts as a dual antagonist of L- and T-type voltage-gated calcium channels, inhibiting the transmembrane influx of calcium ions into cardiac myocytes, vascular smooth muscle cells, and adrenal cortical cells. This suppression of intracellular calcium availability attenuates adrenal aldosterone secretion, diminishes cardiac automaticity, and induces systemic vasodilation, providing clinical relevance for regulating vascular and endothelial function.

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>).