Nilvadipine Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

A clinical trial evaluated the therapeutic utility of the calcium channel blocker nilvadipine in patients with mild to moderate Alzheimer's disease. Conducted as a completed, academic investigator-sponsored Phase 3 European multicenter study, the trial investigated the safety and efficacy of the compound in this neurodegenerative condition. Overall, clinical evaluation underscores its potential application in targeting neurodegenerative disorders alongside its established vascular profile.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02017340	COMPLETED	Alzheimer's Disease	Prof Brian Lawlor	2013-04-24	PHASE3

(data from https://clinicaltrials.gov, updated on 2017-03-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nilvadipine functions as a potent calcium channel blocker that selectively inhibits L-type voltage-gated calcium channels, thereby suppressing transmembrane calcium influx into vascular smooth muscle and neuronal cells. This inhibition attenuates vascular tone and reduces calcium-mediated cytotoxicity, providing a mechanistic basis for its therapeutic investigation in clinical trials evaluating mild to moderate Alzheimer's disease.

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>).