Vorapaxar

Overview

Vorapaxar is a tricyclic himbacine-derived selective inhibitor of protease activated receptor (PAR-1) indicated for reducing the incidence of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). By inhibiting PAR-1, a thrombin receptor expressed on platelets, vorapaxar prevents thrombin-related platelet aggregation.

Background

Indication

Vorapaxar is indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or peripheral arterial disease (PAD). It is usually co-administered with acetylsalicylic acid (ASA) and/or clopidogrel, and should therefore be administered as an addition to these medications as it has not been studied alone.

Associated Conditions

Cardiovascular Events

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Vorapaxar on Thrombin Generation and Coagulability	2017/07/02	NCT03207451	Phase 4	Completed	Inova Health Care Services
Vorapaxar and Lower Extremity Bypass Grafts	2016/11/29	NCT02975583	Phase 4	Withdrawn	Vanderbilt University
Vorapaxar in the Human Endotoxemia Model	2016/08/23	NCT02875028	Phase 4	Completed	Medical University of Vienna
Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)	2016/01/21	NCT02660866	Phase 4	UNKNOWN	North Texas Veterans Healthcare System
Vorapaxar as an Add-On Antiplatelet Therapy in Patients With and Without Diabetes Mellitus	2015/09/14	NCT02548650	Phase 4	Completed	University of Florida
Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor	2015/09/10	NCT02545933	Phase 4	Completed	University of Florida
Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access	2015/06/19	NCT02475837	Phase 2	Completed	Ken Mahaffey
Attenuation of D-dimer Using Vorapaxar to Target Inflammatory and Coagulation Endpoints	2015/03/20	NCT02394730	Phase 1	Completed	Kirby Institute
Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016)	2008/05/26	NCT00684203	Phase 2	Completed	Merck Sharp & Dohme LLC
Trial to Assess the Safety of Vorapaxar in Japanese Subjects With Cerebral Infarction (P05005; MK-5348-017)	2008/05/26	NCT00684515	Phase 2	Completed	Merck Sharp & Dohme LLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ZONTIVITY	WraSer Pharmaceuticals, LLC	66992-208	ORAL	2.08 mg in 1 1	10/18/2022
ZONTIVITY	Aralez Pharmaceuticals Us Inc.	70347-208	ORAL	2.08 mg in 1 1	4/8/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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