Vorapaxar (MK-5348) Clinical Trials

Size	Price	Qty
5mg	USD 170
25mg	USD 490

Clinical Trials

Vorapaxar has been evaluated in multiple clinical trials spanning Phase 1 through Phase 4, primarily investigating cardiovascular and cerebrovascular conditions—including atherosclerosis, myocardial infarction, peripheral arterial disease, cerebral infarction, and coronary artery disease—as well as diabetes mellitus, HIV-associated coagulopathy, and arteriovenous fistula maturation. Sponsored by both pharmaceutical industry entities and academic or healthcare institutions, these studies encompass completed, withdrawn, and terminated recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02660866	UNKNOWN	Peripheral Arterial Disease	North Texas Veterans Healthcare System	2016-07	PHASE4
NCT02545933	COMPLETED	Myocardial Infarction	University of Florida	2016-02	PHASE4
NCT02548650	COMPLETED	Myocardial Infarction; Diabetes Mellitus; Peripheral Arterial Disease	University of Florida	2016-03-25	PHASE4
NCT03207451	COMPLETED	Coronary Artery Disease; Peripheral Vascular Disease; Myocardial Infarction	Inova Health Care Services	2016-01-01	PHASE4
NCT02975583	WITHDRAWN	Peripheral Artery Disease	Vanderbilt University	2017-10-01	PHASE4
NCT02394730	COMPLETED	HIV	Kirby Institute	2015-09	PHASE1; PHASE2
NCT02475837	COMPLETED	AV Fistula	Ken Mahaffey	2015-08-26	PHASE2
NCT02875028	COMPLETED	Healthy Volunteers	Medical University of Vienna	2016-06	PHASE4
NCT00526474	COMPLETED	Atherosclerosis; Ischemia; Myocardial Infarction; Cerebrovascular Accident; Peripheral Arterial Disease	Merck Sharp & Dohme LLC	2007-09-01	PHASE3
NCT00527943	TERMINATED	Atherosclerosis; Myocardial Ischemia; Myocardial Infarction	Merck Sharp & Dohme LLC	2007-12-01	PHASE3
NCT00617123	COMPLETED	Atherosclerosis; Ischemia; Myocardial Infarction; Cerebrovascular Accident	Merck Sharp & Dohme LLC	2008-07-01	PHASE3
NCT00684515	COMPLETED	Cerebral Infarction	Merck Sharp & Dohme LLC	2006-09-21	PHASE2
NCT00684203	COMPLETED	Atherosclerosis; Myocardial Ischemia; Myocardial Infarction	Merck Sharp & Dohme LLC	2006-12-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2018-05-29)

Check the Vorapaxar (MK-5348) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vorapaxar functions as a potent, orally active antagonist that selectively binds to protease-activated receptor 1 (PAR-1) with a Ki of 8.1 nM, thereby blocking thrombin-induced receptor activation and downstream intracellular signaling pathways. By inhibiting thrombin-mediated platelet activation and aggregation, the compound suppresses arterial thrombosis, demonstrating clinical relevance in managing ischemic conditions such as myocardial infarction and peripheral arterial 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>).