Drugs / Vorapaxar
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed myocardial infarction 1 milestone | |||||
| Filed | US (FDA) | — | myocardial infarction | 2013-07-24 | “the New Drug Application (NDA) for its investigational anti-thrombotic medicine, vorapaxar, has been accepted for standard review by the U.S. Food and Drug Administration (FDA).” merck.com ↗ |
| Withdrawn Indication not stated 3 milestones | |||||
| Withdrawn | EU (EMA) | Zontivity | — | 2017-06-23 | europa.eu ↗ |
| Approved | EU (EMA) | Zontivity | — | 2015-01-19 | europa.eu ↗ |
| Approved | US (FDA) | ZONTIVITY | — | 2014-05-08 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial · 1 missed | ||||||
| Phase 1/2 | NCT02394730 | Sep 2015 → Nov 2017 | HIV infectious disease | Kirby Institute | Completed | Missed primary |
| Phase 23 trials | ||||||
| Phase 2 | NCT00684203 | Dec 2006 → Oct 2007 | atherosclerosis, myocardial infarction, myocardial ischemia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00684515 | Sep 2006 → Nov 2007 | cerebral infarction | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00132912 | Aug 2005 → Jan 2007 | arterial occlusion, coronary artery disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT00617123 | Jul 2008 → Oct 2010 | atherosclerosis, ischemic disease, myocardial infarction, stroke disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00527943 | Dec 2007 → Jul 2011 | atherosclerosis, myocardial infarction, myocardial ischemia | Merck Sharp & Dohme LLC | Terminated | Missed primary |
| Phase 3 | NCT00526474 | Sep 2007 → Dec 2011 | atherosclerosis, ischemic disease, myocardial infarction, peripheral arterial disease +1 | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 44 trials · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT02875028 | Jun → Nov 2016 | — | Medical University of Vienna | Completed | Met primary |
| Phase 4 | NCT02548650 | Mar 2016 → Dec 2018 | diabetes mellitus, myocardial infarction, peripheral arterial disease | University of Florida | Completed | Missed primary |
| Phase 4 | NCT02545933 | Feb 2016 → May 2019 | myocardial infarction | University of Florida | Completed | Met primary |
| Phase 4 | NCT03207451 | Jan 2016 → Jul 2018 | coronary artery disorder, myocardial infarction, peripheral vascular disease | Inova Health Care Services | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT02475837 Comparator | Aug 2015 → Oct 2017 | cardiovascular disorder | Ken Mahaffey | Completed | No outcome recorded |
| Phase 4 | NCT02975583 Comparator | Oct 2017 → Jan 2018 | peripheral arterial disease | Vanderbilt University | Withdrawn | No outcome recorded |
| Phase 4 | NCT02660866 Comparator | Jul 2016 → Jul 2019 | peripheral arterial disease | North Texas Veterans Healthcare System | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2015-03-05 | Merck Sharp & Dohme LLC | Results Two New Post-Hoc Analyses of TRA 2°P TIMI 50 Study Showed ZONTIVITY® (vorapaxar) Added to Aspirin and/or Clopidogrel Reduced Acute Limb Ischemia and Peripheral Revascularizations, Respectively, in Certain Patients with Peripheral Arterial Disease merck.com ↗ |
| 2014-05-12 | Merck Sharp & Dohme LLC | Regulatory FDA Approves ZONTIVITY™ (vorapaxar), First-in-Class PAR-1 Antagonist, for the Reduction of Thrombotic Cardiovascular Events in Patients with a History of Heart Attack or with Peripheral Arterial Disease merck.com ↗
Merck (NYSE: MRK ), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ZONTIVITY™ (vorapaxar) for the reduction of thrombotic cardiovascular events in patients with a history of heart attack (myocardial infarction) or in patients with narrowing of leg arteries, called peripheral arterial disease (PAD). |
| 2014-01-15 | Merck Sharp & Dohme LLC | Regulatory Merck Statement on FDA Advisory Committee for Vorapaxar, Merck’s Investigational Antiplatelet Medicine merck.com ↗
Merck (NYSE: MRK ), known as MSD outside the United States and Canada, today said it was pleased with the U.S. Food and Drug Administration (FDA)’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar. |
| 2013-07-24 | Merck Sharp & Dohme LLC | Regulatory Merck Announces FDA Acceptance of New Drug Application for Vorapaxar, Investigational Anti-Thrombotic Medicine merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for its investigational anti-thrombotic medicine, vorapaxar, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). |
| 2012-03-24 | Merck Sharp & Dohme LLC | Results In TRA-2P Study, Adding Merck’s Vorapaxar to Standard of Care Significantly Reduced the Risk of Cardiovascular Events merck.com ↗
In the study, the addition of vorapaxar to standard of care (e.g. aspirin, or thienopyridine or both) resulted in a significantly greater reduction in the risk of the composite of cardiovascular (CV) death, heart attack, stroke or urgent coronary revascularization. |
| 2012-02-07 | Merck Sharp & Dohme LLC | Results Merck Announces Top-Line Results of TRA-2P Study of Vorapaxar merck.com ↗
TRA-2P showed that the addition of vorapaxar to standard of care significantly reduced the risk of the protocol-specified primary endpoint of the composite of cardiovascular death (CVD), heart attack (myocardial infarction, or MI), stroke or urgent coronary revascularization compared to standard of care. |
| 2011-11-13 | Merck Sharp & Dohme LLC | Results Data from TRACER Study of Vorapaxar, Merck’s Investigational Medicine for Cardiovascular Disease, Presented at AHA and Published in NEJM merck.com ↗
TRACER did not achieve primary endpoint |
All press releases naming this drug 8 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vorapaxar | “Vorapaxar is a protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of thrombin-mediated platelet aggregation.” NCT02548650 ↗ |
| Known as | MK-5348 | “the efficacy and safety of vorapaxar (SCH 530348; MK-5348) were assessed by baseline risk among patients with previous MI without prior stroke or transient ischemic attack for...” PMID 27440003 ↗ Jul 2016 |
| Known as | SCH 530348 | “the efficacy and safety of vorapaxar (SCH 530348; MK-5348) were assessed by baseline risk among patients with previous MI without prior stroke or transient ischemic attack for...” PMID 27440003 ↗ Jul 20163“Vorapaxar, formerly SCH 530348, is a novel, orally active, potent thrombin receptor inhibitor selective for the protease-activated receptor-1 (PAR-1).” PMID 20947374 ↗ Oct 2010 “Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)” NCT00617123 ↗ |
| Known as | VORAPAXAR SULFATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL493982 ↗ |
| Known as | Zontivity | “Drug: Vorapaxar 2.08 mg orally daily for a year Other name: Zontivity” NCT02975583 ↗ |
| Action | Inhibit | “an oral platelet protease-activated receptor-1 antagonist” PMID 19286091 ↗ Mar 20091“Proteinase-activated receptor 1 antagonist” CHEMBL493982 ↗ |
| Modality | Small molecule | — CHEMBL493982 ↗ |
| Route | Oral | “Those in the SCH 530348 group who subsequently underwent PCI (primary PCI cohort) continued taking an oral maintenance dose” PMID 19286091 ↗ Mar 2009 |
| Target | F2R | “Proteinase-activated receptor 1 antagonist” CHEMBL493982 ↗ |