Ranolazine Clinical Trials

Size	Price	Qty
200mg	USD 247

Clinical Trials

Multiple Phase II and Phase IV clinical trials have evaluated ranolazine across diverse cardiovascular and metabolic conditions, including chronic stable angina, myocardial ischemia, ventricular premature complexes, metabolic syndrome, and diabetic peripheral neuropathic pain. Sponsored by academic medical centers, regional research groups, and pharmaceutical entities such as Gilead Sciences, the University of Florida, and OBS Pakistan, trial recruitment statuses range from completed and terminated to unknown. These investigations specifically targeted inflammatory and metabolic markers in angina as well as arrhythmia management in ischemic heart disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03486561	Unknown status	Chronic Stable Angina	OBS Pakistan	2018-04-01	Phase 4
NCT03044964	Unknown status	Angina	Amit Malhotra MD\|Gilead Sciences\|Stern Cardiovascular Foundation Inc.	2017-01-10	Phase 4
NCT02252406	Completed	Stable Angina\|Metabolic Syndrome	University of Florida	2015-09	Phase 4
NCT02360397	Completed	Ventricular Premature Complexes\|Myocardial Ischemia	Kent Hospital Rhode Island\|Gilead Sciences	2014-12	Phase 2
NCT02156336	Terminated	Diabetic Peripheral Neuropathic Pain	Horizons International Peripheral Group\|Gilead Sciences	2014-05	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ranolazine selectively inhibits the late inward sodium current in cardiomyocytes, which attenuates intracellular sodium accumulation and suppresses secondary calcium overload driven by the sodium-calcium exchanger during ischemic stress. By restoring cellular ionic balance, it improves myocardial relaxation and reduces wall tension, mitigating intracellular hypoxia and offering clinical efficacy in conditions such as chronic stable angina and myocardial ischemia.

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>).