Drugs / Vorapaxar

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Withdrawn EU (EMA) Zontivity 2017-06-23 europa.eu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 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT02394730 Sep 2015 → Nov 2017 HIV infectious disease Kirby Institute Completed No outcome recorded
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
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 No outcome recorded
Phase 3 NCT00526474 Sep 2007 → Dec 2011 atherosclerosis, ischemic disease, myocardial infarction, peripheral arterial disease +1 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 44 trials
Phase 4 NCT02875028 Jun → Nov 2016 Medical University of Vienna Completed No outcome recorded
Phase 4 NCT02548650 Mar 2016 → Dec 2018 diabetes mellitus, myocardial infarction, peripheral arterial disease University of Florida Completed No outcome recorded
Phase 4 NCT02545933 Feb 2016 → May 2019 myocardial infarction University of Florida Completed No outcome recorded
Phase 4 NCT03207451 Jan 2016 → Jul 2018 coronary artery disorder, myocardial infarction, peripheral vascular disease Inova Health Care Services Completed No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT02475837 Comparator Aug 2015 → Oct 2017 cardiovascular disorder Ken Mahaffey Completed No outcome recorded
Phase 42 trials
Phase 4 NCT02975583 Comparator Oct 2017 → Jan 2018 peripheral arterial disease Vanderbilt University Withdrawn No outcome recorded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

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as Vorapaxar Vorapaxar is a protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of thrombin-mediated platelet aggregation.” NCT02548650
12

NCT02475837

NCT02545933

NCT00684203

NCT00617123

NCT02975583

NCT03207451

NCT00684515

NCT00527943

NCT02875028

NCT02394730

NCT02660866

NCT00526474

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 2016
3

“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

NCT00132912

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: ZontivityNCT02975583
Action Inhibit “an oral platelet protease-activated receptor-1 antagonist” PMID 19286091 Mar 2009
1

“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