Nicorandil Clinical Trials

Size	Price	Qty
50mg	USD 79
1g	USD 670

Clinical Trials

Several clinical trials evaluate the therapeutic potential and pharmacokinetic profile of Nicorandil across Early Phase 1, Phase 2, and Phase 4 evaluations. Sponsored by pharmaceutical companies and academic centers—including Auxilius Pharma, Taipei Medical University WanFang Hospital, and Merck KGaA—research focuses on cardiovascular indications such as chronic stable angina and coronary heart disease, alongside exploratory indications like radiation pneumonitis. Featuring recruitment statuses of active not recruiting, completed, and unknown, these protocols investigate extended-release pharmacokinetics and clinical outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06249581	Active not recruiting	Chronic Stable Angina	Auxilius Pharma sp.z.o.o.	2023-11-27	Early Phase 1
NCT02809456	Unknown status	Radiation Pneumonitis	Taipei Medical University WanFang Hospital	2016-07	Phase 2
NCT01396395	Completed	Stable Angina\|Coronary Disease	Merck KGaA Darmstadt Germany\|Merck Serono Co. Ltd. China	2011-09	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nicorandil functions as a dual ATP-sensitive potassium channel activator and nitric oxide donor that stimulates soluble guanylate cyclase, increasing cGMP levels and promoting myosin light chain dephosphorylation. This pathway mediates vascular smooth muscle relaxation and systemic vasodilation, providing therapeutic relevance for clinical conditions such as chronic stable angina, coronary disease, and radiation pneumonitis.

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>).