Prasugrel
Small molecule targets P2RY12 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acute coronary syndrome 2 milestones | |||||
| Filed | US (FDA) | Effient | acute coronary syndrome | 2007-12-26 | “Lilly, on behalf of its alliance partner, Daiichi Sankyo, submitted a new drug application to the FDA for prasugrel in December 2007.” lilly.com ↗ “new drug application that Lilly submitted for prasugrel on behalf of the alliance with Daiichi Sankyo, Limited, on December 26, 2007.” lilly.com ↗ “new drug application that Lilly submitted for prasugrel on behalf of the alliance with Daiichi Sankyo on December 26, 2007.” daiichisankyo.com ↗ “they submitted a New Drug Application (NDA) for prasugrel to the U.S. Food and Drug Administration (FDA).” lilly.com ↗ “submitted a New Drug Application to the U.S. Food and Drug Administration for prasugrel in December 2007” lilly.com ↗ “submitted a New Drug Application (NDA) for prasugrel to the U.S. Food and Drug Administration (FDA).” lilly.com ↗ |
| Filed | EU (EMA) | — | acute coronary syndrome | — | “Lilly, on behalf of the alliance, also submitted a Marketing Authorization Application for prasugrel to the European Medicines Agency in February 2008.” lilly.com ↗ |
| Filed ischemic stroke 1 milestone | |||||
| Filed | Japan (PMDA) | — | ischemic stroke | 2020-12-15 | “prasugrel), was filed in Japan to expand the indication for prevention of recurrence of ischemic stroke as a partial change” daiichisankyo.com ↗ |
| Filed myocardial ischemia 1 milestone | |||||
| Filed | Japan (PMDA) | — | myocardial ischemia | 2013-06-18 | “has submitted a New Drug Application to the Ministry of Health, Labour and Welfare in Japan” daiichisankyo.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | EFFIENT | — | 2013-10-16 – 2016-07-12 | fda.gov ↗ |
| Approved | US (FDA) | EFFIENT | — | 2009-07-10 | fda.gov ↗ |
| Approved | EU (EMA) | Efient | — | 2009-02-24 | europa.eu ↗ |
Trials 119 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials · 2 met primary | ||||||
| Phase 1 | NCT03430661 | Jan 2018 → May 2019 | — | Viatris Innovation GmbH | Completed | No outcome recorded |
| Phase 1 | NCT03054207 | Jun 2015 → Apr 2017 | HIV infectious disease | Jules Desmeules | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02075268 | Jan → Feb 2014 | — | Asan Medical Center | Unknown | No outcome recorded |
| Phase 1 | NCT01876797 | Jul → Aug 2013 | — | Asan Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT01648790 | Jul → Aug 2012 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01346800 | Feb → Jun 2011 | — | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 1 | NCT01178099 | Jul 2010 → Jan 2011 | sickle cell disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01107912 | Mar 2010 → Oct 2011 | coronary artery disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 1 | NCT01107925 | Mar 2010 → Aug 2011 | coronary artery disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 1 | NCT01107899 | Oct 2009 → Dec 2010 | acute coronary syndrome | Eli Lilly and Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01591317 | Mar → May 2009 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 215 trials · 3 met primary · 2 missed | ||||||
| Phase 2 | NCT04766437 | Feb 2021 → Sep 2022 | acute coronary syndrome | Academic Medical Center - University of Amsterdam | Completed | No outcome recorded |
| Phase 2 | NCT03606642 | Nov 2018 → Dec 2021 | atherosclerosis, coronary artery disorder | HonorHealth Research Institute | Terminated | No outcome recorded |
| Phase 2 | NCT01979445 | Dec 2013 → Jan 2014 | coronary artery disorder | The Medicines Company | Completed | No outcome recorded |
| Phase 2 | NCT01852019 | Jun → Jul 2013 | coronary artery disorder | The Medicines Company | Completed | No outcome recorded |
| Phase 2 | NCT02285751 | Nov 2012 → Jul 2020 | critical illness polyneuropathy | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 2 | NCT01597375 | Aug 2012 → Dec 2016 | aspirin-induced respiratory disease | Elliot Israel, MD | Completed | No outcome recorded |
| Phase 2 | NCT01476696 | Nov 2011 → Nov 2012 | sickle cell disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01167023 | Jul 2010 → Jun 2011 | sickle cell disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01115738 | May 2010 → Nov 2011 | acute coronary syndrome | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00910299 | Jul 2009 → Apr 2011 | coronary artery disorder | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 2 | NCT00642174 | Apr 2008 → Jan 2009 | coronary artery disorder, diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT00385944 | Mar → Oct 2007 | acute coronary syndrome | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT00357968 | Aug 2006 → Jun 2007 | coronary artery disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00356135 | Jul 2006 → Dec 2008 | acute coronary syndrome, arteriosclerosis disorder | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT00059215 | Apr 2003 → Jan 2004 | heart disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT05657041 | Apr 2023 → Aug 2024 | coronary artery disorder | St. Antonius Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT02044146 | Sep 2014 → Oct 2016 | acute coronary syndrome | Ottawa Heart Institute Research Corporation | Completed | No outcome recorded |
| Phase 2/3 | NCT01452139 | Sep 2011 → Sep 2012 | ST-elevation myocardial infarction | Ottawa Heart Institute Research Corporation | Completed | No outcome recorded |
| Phase 2/3 | NCT01184300 | Aug 2010 → Jul 2011 | acute coronary syndrome, coronary artery disorder | Ottawa Heart Institute Research Corporation | Completed | No outcome recorded |
| Phase 328 trials · 4 met primary · 3 missed | ||||||
| Phase 3 | NCT07582835 | Apr 2026 → Apr 2028 expected | acute coronary syndrome, coronary artery disorder | Cardiocentro Ticino | Recruiting | No outcome recorded |
| Phase 3 | NCT07195149 | Nov 2025 → Apr 2030 expected | coronary artery disorder | Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o. | Recruiting | No outcome recorded |
| Phase 3 | NCT05952206 | Oct 2023 → Jan 2027 expected | coronary artery disorder | iVascular S.L.U. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05903976 | Jun 2023 → Jun 2025 | acute coronary syndrome, coronary artery disorder | Azienda Ospedaliera Universitaria Policlinico "G. Martino" | Unknown | No outcome recorded |
| Phase 3 | NCT05779059 | Apr 2023 → Dec 2024 | acute coronary syndrome, intermediate coronary syndrome, myocardial infarction | Collegium Medicum w Bydgoszczy | Unknown | No outcome recorded |
| Phase 3 | NCT04360720 | Oct 2020 → Nov 2024 | acute coronary syndrome | Hospital Israelita Albert Einstein | Completed | No outcome recorded |
| Phase 3 | NCT02944123 | Sep 2016 → Feb 2020 | acute coronary syndrome | Dong-A University | Completed | No outcome recorded |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | Mixed |
| Phase 3 | NCT01774838 | Oct 2014 → Jun 2015 | acute coronary syndrome, intermediate coronary syndrome | University of Cologne | Completed | No outcome recorded |
| Phase 3 | NCT02075125 | Jan 2014 → Apr 2015 | ST-elevation myocardial infarction | Dong-A University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01641510 | Oct 2013 → Oct 2018 | acute coronary syndrome | Dong-A University | Completed | No outcome recorded |
| Phase 3 | NCT01794000 | Apr 2013 → Jul 2015 | sickle cell disease | Eli Lilly and Company | Terminated | Missed primary |
| Phase 3 | NCT01778842 | Mar → Jun 2013 | coronary artery disorder | Gennaro Sardella | Unknown | No outcome recorded |
| Phase 3 | NCT01560780 | Feb 2013 → Apr 2018 | — | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 3 | NCT01609647 | Sep 2012 → Dec 2014 | acute coronary syndrome | Dong-A University | Completed | Met primary |
| Phase 3 | NCT01543932 | Jul 2012 → Dec 2013 | coronary artery disorder | University of Roma La Sapienza | Completed | No outcome recorded |
| Phase 3 | NCT01515345 | Jul 2011 → Jan 2013 | coronary artery disorder, platelet aggregation, spontaneous | Kaiser Franz Josef Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01327534 | May 2011 → Mar 2013 | ST-elevation myocardial infarction | Stiftung Institut fuer Herzinfarktforschung | Completed | No outcome recorded |
| Phase 3 | NCT01338909 | Apr → Sep 2011 | myocardial infarction | University of Patras | Completed | No outcome recorded |
| Phase 3 | NCT01598337 | Apr 2011 → Dec 2013 | coronary artery disorder | Prince Sultan Cardiac Center, Adult Cardiology Department. | Unknown | No outcome recorded |
| Phase 3 | NCT01304472 | Feb → Apr 2011 | coronary artery disorder | University of Patras | Completed | No outcome recorded |
| Phase 3 | NCT01155765 | May → Jul 2010 | chronic renal failure syndrome | University of Patras | Completed | No outcome recorded |
| Phase 3 | NCT01336348 | Apr 2010 → Jun 2011 | ST-elevation myocardial infarction | Università degli Studi di Ferrara | Completed | No outcome recorded |
| Phase 3 | NCT01109784 | Apr → Jul 2010 | acute coronary syndrome, coronary artery disorder | University of Patras | Completed | Met primary |
| Phase 3 | NCT01015287 | Dec 2009 → Jan 2013 | acute coronary syndrome | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00830960 | Feb 2009 → Jun 2010 | acute coronary syndrome | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00699998 | Jun 2008 → Apr 2012 | acute coronary syndrome | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00097591 | Nov 2004 → Jul 2007 | acute coronary syndrome, coronary atherosclerosis | Eli Lilly and Company | Completed | Met primary |
| Phase 453 trials · 7 met primary · 9 missed | ||||||
| Phase 4 | NCT07507500 | Sep 2026 → Jul 2029 expected | acute myocardial infarction | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | Recruiting | No outcome recorded |
| Phase 4 | NCT06916520 | Nov 2025 → Apr 2026 overdue | coronary artery disorder | J.P.S Henriques | Recruiting | No outcome recorded |
| Phase 4 | NCT07025148 | Oct 2025 → Aug 2027 expected | coronary artery disorder | University of Florida | Recruiting | No outcome recorded |
| Phase 4 | NCT06821191 | Mar 2025 → Nov 2026 expected | coronary artery disorder | University of Florida | Recruiting | No outcome recorded |
| Phase 4 | NCT06691191 | Jan 2025 → Aug 2026 overdue | coronary artery disorder | University of Florida | Recruiting | No outcome recorded |
| Phase 4 | NCT06588595 | Nov 2024 → Aug 2027 expected | coronary artery disorder | University of Florida | Recruiting | No outcome recorded |
| Phase 4 | NCT06613191 | Oct 2024 → Dec 2025 overdue | coronary artery disorder, peripheral vascular disease | Ochsner Health System | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05773989 | Jan → Dec 2024 | coronary artery disorder | St. Antonius Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05955365 | Dec 2023 → Dec 2027 expected | atrial fibrillation | Insel Gruppe AG, University Hospital Bern | Recruiting | No outcome recorded |
| Phase 4 | NCT06400940 | Aug 2023 → Aug 2026 overdue | brain aneurysm | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health | Recruiting | No outcome recorded |
| Phase 4 | NCT05681702 | Feb 2023 → Dec 2026 expected | coronary artery disorder | University of Florida | Recruiting | No outcome recorded |
| Phase 4 | NCT05491200 | Jul 2022 → Aug 2027 expected | ST-elevation myocardial infarction | Research Maatschap Cardiologen Rotterdam Zuid | Recruiting | No outcome recorded |
| Phase 4 | NCT05262803 | Jun 2022 → Dec 2028 expected | myocardial infarction | Rikke Sorensen | Recruiting | No outcome recorded |
| Phase 4 | NCT05223335 | Mar 2022 → Mar 2023 | hemorrhagic disease | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT05183178 | Feb 2022 → Aug 2025 | acute coronary syndrome | Vastra Gotaland Region | Completed | No outcome recorded |
| Phase 4 | NCT05066789 | Jan 2022 → Mar 2024 | coronary artery disorder | Samsung Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT04981041 | Dec 2021 → May 2026 | acute coronary syndrome, atrial fibrillation | Ludwig-Maximilians - University of Munich | Completed | No outcome recorded |
| Phase 4 | NCT04668144 | Feb 2021 → Feb 2023 | acute coronary syndrome, coronary artery disorder | University of Florida | Completed | Missed primary |
| Phase 4 | NCT04505774 | Sep 2020 → Aug 2023 | COVID-19 | Matthew Neal MD | Completed | Missed primary |
| Phase 4 | NCT04734353 | Jan 2020 → Jun 2021 | coronary artery disorder | Gyeongsang National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02302508 | Sep 2019 → Dec 2020 | diabetes mellitus | University of Montreal Hospital Centre (CHUM) | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT03581409 | Oct 2018 → Jan 2021 | brain aneurysm | Seoul National University Hospital | Completed | Met primary |
| Phase 4 | NCT03672097 | Oct 2018 → Aug 2020 | acute coronary syndrome | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT03387826 | Jan 2018 → Jan 2019 | coronary artery disorder, diabetes mellitus, kidney disorder, myocardial infarction | Attikon Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05643586 | Dec 2017 → Apr 2019 | coronary artery disorder | Germano Di Sciascio | Completed | No outcome recorded |
| Phase 4 | NCT03296540 | Nov 2017 → May 2021 | cardiovascular disorder | Maasstad Hospital | Completed | Missed primary |
| Phase 4 | NCT02605447 | Feb 2016 → Jul 2019 | coronary artery disorder | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase 4 | NCT02601157 | Jan 2016 → Aug 2021 | intermediate coronary syndrome, myocardial infarction | Seoul National University Hospital | Completed | Mixed |
| Phase 4 | NCT02548611 | Sep 2015 → Aug 2018 | intermediate coronary syndrome | LMU Klinikum | Terminated | Missed primary Stop: Enrollment |
| Phase 4 | NCT02376283 | Mar 2015 → Nov 2016 | acute myocardial infarction | The Royal Wolverhampton Hospitals NHS Trust | Completed | No outcome recorded |
| Phase 4 | NCT02642419 | Jan 2015 → Dec 2017 | atrial fibrillation | Japan Cardiovascular Research Foundation | Unknown | Met primary |
| Phase 4 | NCT02251249 | Dec 2014 → Sep 2016 | acute myocardial infarction, gastroparesis | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 4 | NCT02212028 | Oct 2014 → Aug 2015 | coronary artery disorder | University of Florida | Completed | Met primary |
| Phase 4 | NCT02193971 | Jul 2014 → Oct 2020 | acute coronary syndrome | Seoul National University Hospital | Completed | Met primary |
| Phase 4 | NCT01957540 | Jun 2014 → Dec 2015 | coronary artery disorder | University of Patras | Completed | Missed primary |
| Phase 4 | NCT01823185 | Mar 2013 → Jan 2016 | coronary artery disorder, ischemic disease, myocardial infarction, thrombotic disease | Imam Abdulrahman Bin Faisal University | Unknown | No outcome recorded |
| Phase 4 | NCT02808767 | Jan 2013 → May 2016 | acute myocardial infarction | Faculty Hospital Kralovske Vinohrady | Completed | No outcome recorded |
| Phase 4 | NCT01790854 | Nov 2012 → Oct 2014 | acute coronary syndrome | David Antoniucci | Terminated | No outcome recorded |
| Phase 4 | NCT01777503 | Nov 2012 → Jan 2017 | acute coronary syndrome, coronary atherosclerosis | Azienda USL Reggio Emilia - IRCCS | Completed | Missed primary |
| Phase 4 | NCT01684813 | Oct 2012 → Oct 2013 | acute coronary syndrome, type 2 diabetes mellitus | Andalusian Public Foundation for Health Research in Seville | Completed | Met primary |
| Phase 4 | NCT01587651 | Mar 2012 → Feb 2013 | coronary artery disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT01538446 | Mar 2012 → May 2016 | acute coronary syndrome | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 4 | NCT01452152 | Feb 2012 → Jul 2013 | acute coronary syndrome | University of Maryland, Baltimore | Terminated | No outcome recorded |
| Phase 4 | NCT01477775 | Jan 2012 → Dec 2014 | acute coronary syndrome, coronary artery disorder | Italian Society of Invasive Cardiology | Unknown | No outcome recorded |
| Phase 4 | NCT01463150 | Oct 2011 → Jul 2012 | qualitative platelet defect | University of Patras | Completed | Met primary |
| Phase 4 | NCT01612884 | Aug 2011 → Mar 2017 | coronary artery disorder, thrombotic disease | Indiana University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01305369 | Mar → Dec 2011 | chronic asthma | University of Milan | Completed | No outcome recorded |
| Phase 4 | NCT01260584 | Nov 2010 → Sep 2011 | coronary artery disorder | Daiichi Sankyo | Completed | Met primary |
| Phase 4 | NCT01069003 | Apr 2010 → Apr 2014 | coronary artery disorder | Medtronic Vascular | Completed | No outcome recorded |
| Phase 4 | NCT01014624 | Feb → May 2010 | coronary artery disorder | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT01099566 | Nov 2009 → Oct 2010 | infectious disease with sepsis | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT00976092 | Sep 2009 → Feb 2014 | myocardial infarction | German Heart Center Munich | Unknown | Missed primary |
| Phase 4 | NCT00827411 | Jan 2009 → Mar 2012 | acute coronary syndrome, coronary artery disorder | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase not applicable8 trials · 2 met primary | ||||||
| — | NCT05650411 | Apr 2026 → May 2028 expected | coronary stenosis | IGLESIAS Juan Fernando | Recruiting | No outcome recorded |
| — | NCT05117866 | Sep 2020 → Jul 2024 overdue | acute coronary syndrome, coronary artery disorder | Meditrix Corp | Active not recruiting | No outcome recorded |
| — | NCT03469856 | Feb 2018 → Jul 2019 | — | Pedro A. Lemos | Unknown | No outcome recorded |
| — | NCT03111420 | Jan 2017 → Jun 2018 | platelet disorder, undefined | Aggredyne, Inc. | Completed | No outcome recorded |
| — | NCT02865824 | Jan 2016 → Dec 2018 | polyp of colon | Incheon St.Mary's Hospital | Unknown | No outcome recorded |
| — | NCT02079194 | Mar 2014 → Jul 2018 | coronary artery disorder | Samsung Medical Center | Unknown | Met primary |
| — | NCT01701453 | Aug 2012 → Nov 2017 | acute coronary syndrome | Samsung Medical Center | Unknown | Met primary |
| — | NCT01212302 | Oct 2008 → Mar 2010 | coronary artery disorder | Ruhr University of Bochum | Completed | No outcome recorded |
| Comparator or background therapy79 trials | ||||||
| Phase 1 | NCT02243137 Background | May 2013 → Jun 2014 | — | David Vivas | Completed | Met primary |
| Phase 1 | NCT01430091 Comparator | Sep → Oct 2011 | sickle cell disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT07032389 Background | Dec 2025 → Jun 2030 expected | acute coronary syndrome | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05514938 Comparator | Nov 2022 → May 2025 | acute coronary syndrome, coronary artery disorder, lip disorder | University of Texas Southwestern Medical Center | Completed | Missed primary |
| Phase 2 | NCT02507323 Comparator | Feb 2016 → Aug 2017 | cardiovascular disorder | Yochai Birnbaum | Withdrawn | No outcome recorded |
| Phase 2 | NCT01103440 Background | Apr 2007 → Jun 2009 | — | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 3 | NCT07629635 Comparator | Oct 2026 → Dec 2027 expected | migraine disorder, patent foramen ovale | Columbia University | Recruiting | No outcome recorded |
| Phase 3 | NCT04445623 Comparator | Jul → Oct 2020 | COVID-19, thrombotic disease | Azienda Ospedaliera Universitaria Integrata Verona | Unknown | No outcome recorded |
| Phase 3 | NCT02866175 Background | Feb 2017 → Jun 2019 | atrial fibrillation | Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Completed | Met primary |
| Phase 3 | NCT01830543 Background | May 2013 → Jul 2016 | atrial fibrillation | Janssen Scientific Affairs, LLC | Completed | Met primary |
| Phase 3 | NCT01531114 Comparator | May 2013 → Jul 2015 | ST-elevation myocardial infarction | Gennaro Sardella | Completed | No outcome recorded |
| Phase 3 | NCT01835353 Comparator | Jun 2012 → Jul 2013 | qualitative platelet defect | University of Patras | Completed | No outcome recorded |
| Phase 3 | NCT02070159 Comparator | Dec 2011 → Dec 2012 | coronary artery disorder | Dong-A University | Completed | No outcome recorded |
| Phase 3 | NCT01465828 Comparator | Oct 2011 → Jan 2012 | acute coronary syndrome | Gennaro Sardella | Completed | No outcome recorded |
| Phase 3 | NCT01505790 Comparator | Jul 2011 → May 2012 | acute coronary syndrome | Assistance Publique Hopitaux De Marseille | Completed | No outcome recorded |
| Phase 3 | NCT01360437 Comparator | May → Dec 2011 | acute coronary syndrome, coronary artery disorder | University of Patras | Completed | Met primary |
| Phase 3 | NCT01510327 Background | Oct 2009 → Feb 2010 | coronary artery disorder | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase 3 | NCT01500434 Background | Feb 2009 → Mar 2011 | coronary artery disorder | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00823212 Background | Jan 2009 → Sep 2010 | coronary atherosclerosis | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase 4 | NCT07684742 Comparator | Jul 2026 → Jul 2031 expected | ST-elevation myocardial infarction, acute coronary syndrome, intermediate coronary syndrome | Gyeongsang National University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06763744 Comparator | Jun 2025 → Jul 2029 expected | acute coronary syndrome, bleeding disorder, vascular-type | Samsung Medical Center | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06718179 Background | Nov 2024 → Nov 2029 expected | acute coronary syndrome | Odense University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05709626 Comparator | Feb 2023 → Jan 2025 overdue | ST-elevation myocardial infarction | Kindai University | Recruiting | No outcome recorded |
| Phase 4 | NCT05767723 Comparator | Feb 2023 → May 2025 overdue | acute coronary syndrome | Hospital Israelita Albert Einstein | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05359224 Comparator | Jun 2022 → Jul 2025 | brain aneurysm | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT04609111 Comparator | Jan 2021 → Dec 2023 | acute coronary syndrome | Kyoto University, Graduate School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT04014803 Comparator | Jan 2020 → Jun 2027 expected | coronary artery disorder | Samsung Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT04006288 Comparator | Sep 2019 → Jan 2022 | coronary artery disorder | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT03489863 Comparator | May 2018 → Mar 2019 | coronary artery disorder | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT03273075 Comparator | Sep 2017 → May 2021 | acute coronary syndrome, cardiac arrest | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 4 | NCT03027934 Comparator | Aug → Oct 2017 | diabetes mellitus | CirQuest Labs, LLC | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02978040 Comparator | Jul 2017 → Aug 2019 | ST-elevation myocardial infarction, coronary artery disorder | Insel Gruppe AG, University Hospital Bern | Completed | Mixed |
| Phase 4 | NCT03062319 Comparator | Apr 2017 → Jul 2023 | atherosclerosis, atrial fibrillation, ischemic stroke | National Hospital Organization Osaka National Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT05247385 Comparator | Mar 2017 → Feb 2021 | coronary artery disorder | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT03016611 Comparator | Feb → Dec 2017 | ST-elevation myocardial infarction, acute coronary syndrome | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02545933 Background | Feb 2016 → May 2019 | myocardial infarction | University of Florida | Completed | Met primary |
| Phase 4 | NCT02587260 Comparator | Dec 2015 → Feb 2017 | cardiovascular disorder | Erasmus Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02487732 Comparator | Jul 2015 → Aug 2016 | acute coronary syndrome | Korea University Anam Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02422888 Comparator | May 2015 → Oct 2017 | myocardial infarction | Amsterdam UMC, location VUmc | Unknown | Missed primary |
| Phase 4 | NCT02261922 Comparator | Oct 2014 → Oct 2015 | platelet adenylate cyclase activity | Hotel Dieu de France Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02118870 Comparator | Jun 2014 → Sep 2017 | acute coronary syndrome | Diagram B.V. | Completed | No outcome recorded |
| Phase 4 | NCT02108808 Comparator | Apr → Oct 2014 | — | University of Patras | Completed | No outcome recorded |
| Phase 4 | NCT02065479 Comparator | Mar 2014 → Apr 2019 | coronary artery disorder | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT02032303 Comparator | Feb → Dec 2014 | ST-elevation myocardial infarction, acute coronary syndrome, intermediate coronary syndrome | Azienda Policlinico Umberto I | Unknown | No outcome recorded |
| Phase 4 | NCT01869309 Comparator | Jan 2014 → Dec 2015 | coronary artery disorder | LifeBridge Health | Unknown | No outcome recorded |
| Phase 4 | NCT01944800 Comparator | Sep 2013 → Jul 2019 | acute coronary syndrome | German Heart Center Munich | Completed | No outcome recorded |
| Phase 4 | NCT01959451 Comparator | Sep 2013 → May 2016 | acute coronary syndrome | LMU Klinikum | Completed | Met primary |
| Phase 4 | NCT01951001 Comparator | Jul 2013 → Jun 2015 | acute coronary syndrome, hemorrhagic disease, thrombotic disease | Gyeongsang National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02215993 Comparator | Jul 2013 → Sep 2014 | acute coronary syndrome, blood platelet disease | Federal University of São Paulo | Completed | No outcome recorded |
| Phase 4 | NCT01789814 Comparator | Jul 2013 → Jul 2014 | coronary artery disorder | Tufts Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02317198 Comparator | Jun 2013 → Nov 2018 | acute coronary syndrome, intermediate coronary syndrome, myocardial infarction | St. Antonius Hospital | Completed | Met primary |
| Phase 4 | NCT01765400 Comparator | May 2013 → Dec 2015 | systolic heart failure | University of Nebraska | Completed | No outcome recorded |
| Phase 4 | NCT02402491 Comparator | Jan 2013 → Jun 2015 | — | Beijing Anzhen Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01805570 Comparator | Nov 2012 → Mar 2013 | myocardial infarction | David Antoniucci | Completed | No outcome recorded |
| Phase 4 | NCT01642966 Comparator | Sep 2012 | acute coronary syndrome | University of Patras | Completed | No outcome recorded |
| Phase 4 | NCT01700322 Comparator | Aug 2012 → Jul 2016 | coronary artery disorder | Johannes Gutenberg University Mainz | Completed | No outcome recorded |
| Phase 4 | NCT01642940 Comparator | Jun → Sep 2012 | acute coronary syndrome, coronary artery disorder | University of Patras | Completed | No outcome recorded |
| Phase 4 | NCT01589978 Background | May 2012 → Aug 2014 | coronary artery disorder | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase 4 | NCT01339026 Comparator | Feb 2012 → Sep 2013 | acute coronary syndrome | Royal Brompton & Harefield NHS Foundation Trust | Terminated | No outcome recorded |
| Phase 4 | NCT01510171 Comparator | Jan → Jun 2012 | ST-elevation myocardial infarction | Careggi Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01463163 Comparator | Oct 2011 → Apr 2012 | qualitative platelet defect | University of Patras | Completed | Missed primary |
| Phase 4 | NCT01493999 Comparator | Sep 2011 → Jan 2013 | acute coronary syndrome | University of Pecs | Completed | No outcome recorded |
| Phase 4 | NCT01456364 Comparator | Sep 2011 → Apr 2014 | coronary artery disorder | German Heart Center Munich | Unknown | No outcome recorded |
| Phase 4 | NCT01365221 Comparator | Oct 2010 → Jan 2014 | acute coronary syndrome | Medstar Health Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT01135667 Comparator | Sep 2010 → Jul 2012 | acute coronary syndrome, coronary artery disorder | Lene Holmvang | Completed | No outcome recorded |
| Phase 4 | NCT01201772 Comparator | Aug 2010 → May 2011 | coronary artery disorder | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT01158846 Comparator | Aug 2010 → Jun 2011 | ST-elevation myocardial infarction, strictly posterior acute myocardial infarction | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio | Unknown | No outcome recorded |
| Phase 4 | NCT00977938 Comparator | Oct 2009 → Jun 2014 | coronary artery disorder | Baim Institute for Clinical Research | Completed | No outcome recorded |
| Phase 4 | NCT00954707 Comparator | Aug 2009 → Jan 2012 | coronary artery disorder | Cordis US Corp. | Unknown | No outcome recorded |
| Phase 4 | NCT01106534 Comparator | Aug 2009 → Feb 2015 | arterial occlusion, coronary restenosis, myocardial ischemia | Abbott Medical Devices | Completed | No outcome recorded |
| — | NCT04708587 Comparator | Mar 2021 → Mar 2027 expected | chronic kidney disease | Yonsei University | Recruiting | No outcome recorded |
| — | NCT04100135 Background | Feb 2021 → Aug 2024 | migraine disorder, patent foramen ovale | W.L.Gore & Associates | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT03435133 Comparator | Nov 2015 → Oct 2018 | ST-elevation myocardial infarction | AORTICA Group | Completed | No outcome recorded |
| — | NCT02303717 Background | Dec 2014 → Dec 2017 | coronary artery disorder | NHS National Waiting Times Centre Board | Unknown | No outcome recorded |
| — | NCT02016170 Comparator | Mar 2014 → Oct 2015 | acute coronary syndrome, coronary artery disorder | University of Florida | Completed | Met primary |
| — | NCT01852214 Comparator | Feb 2013 → Jul 2015 | coronary artery disorder, type 2 diabetes mellitus | University of Florida | Completed | No outcome recorded |
| — | NCT01852175 Comparator | Jan 2012 → Jun 2014 | coronary artery disorder | University of Florida | Completed | No outcome recorded |
| — | NCT01175200 Comparator | Sep 2010 → Jul 2012 | platelet aggregation, spontaneous | Ascopharm Groupe Novasco | Completed | No outcome recorded |
| — | NCT01103843 Comparator | Apr 2010 → Apr 2011 | coronary artery disorder | St. Francis Hospital, New York | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 55
| Date | Issuer | Release |
|---|---|---|
| 2020-12-15 | Daiichi Sankyo | Regulatory Daiichi Sankyo Submits Supplemental Application in Japan for Approval of Partial Changes Related to Additional Indication for the Antiplatelet Agent, Prasugrel Hydrochloride daiichisankyo.com ↗
Daiichi Sankyo Submits Supplemental Application in Japan for Approval of Partial Changes Related to Additional Indication for the Antiplatelet Agent, Prasugrel Hydrochloride |
| 2020-07-21 | Daiichi Sankyo | Results Daiichi Sankyo Announces Phase 3 Study Results for Prasugrel Antiplatelet Agent in Thrombotic Stroke Patients daiichisankyo.com ↗
The incidence of cerebral cardiovascular events (such as ischemic stroke, myocardial infarction, and other vascular deaths) was lower in the prasugrel group than in the clopidogrel group, thus achieving the primary endpoint in the study. |
| 2016-10-21 | Daiichi Sankyo | Results Daiichi Sankyo Announces Phase 3 Clinical Trial (PRASTRO-I Study, PRASTRO-II Study) Results for Prasugrel Antiplatelet Agent for Patients with Ischemic Cerebrovascular Disease daiichisankyo.com ↗
Tokyo, Japan (October 21, 2016) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), today announced the results of Phase 3 clinical trials in Japan of the antiplatelet agent prasugrel hydrochloride (hereafter, prasugrel) for ischemic cerebrovascular disease patients. |
| 2015-06-01 | Daiichi Sankyo | Regulatory Daiichi Sankyo Announces Lifting of Prescription Period Limitation for Antiplatelet Agent Efient® 3.75mg/5mg Tablets in Japan daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the antiplatelet agent Efient® 3.75mg/5mg Tablets (JAN: Prasugrel Hydrochloride), which was launched in Japan in May 2014, has had its prescription period limitation of 14 days lifted based on a notification received from the Japanese Ministry of Health, Labour and Welfare. |
| 2014-03-24 | Daiichi Sankyo | Results Subgroup Analysis of PRASFIT-ACS Study Evaluated Impact of Platelet Reactivity on Prevention of Ischemic Events in Perioperative Period of PCI daiichisankyo.com ↗
the incidence of MACE (major adverse cardiovascular events) within 3 days after percutaneous coronary intervention (PCI) in the prasugrel group was 5.6% versus 8.3% for the clopidogrel group |
| 2014-03-24 | Daiichi Sankyo | Regulatory Daiichi Sankyo Receives Approval in Japan for Manufacturing and Marketing of the Antiplatelet Agent Efient® 3.75mg/5mg Tablets daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has received approval from the Ministry of Health, Labour and Welfare in Japan for the antiplatelet agent Efient® 3.75mg/5mg Tablets (JAN: Prasugrel Hydrochloride) for the treatment of patients with ischemic heart disease undergoing PCI 1. |
| 2013-07-12 | Daiichi Sankyo | Results Daiichi Sankyo Announces Phase 3 Study Results (PRASFIT-Elective Study) for the Antiplatelet Agent Prasugrel in Japan daiichisankyo.com ↗
The incidence of the composite primary endpoint (cardiovascular death, non-fatal myocardial infarction, ischemic stroke) was 4.1 percent in the prasugrel group versus 6.7 percent in the clopidogrel sulfate (hereafter, clopidogrel) group. |
| 2013-06-18 | Daiichi Sankyo | Regulatory Daiichi Sankyo Submits a New Drug Application in Japan for the Antiplatelet Agent Prasugrel daiichisankyo.com ↗ |
| 2013-03-16 | Daiichi Sankyo | Results Daiichi Sankyo Announces Positive Phase 3 Study Results (PRASFIT-ACS) for Prasugrel in Japanese Patients with Acute Coronary Syndrome Undergoing PCI daiichisankyo.com ↗
The incidence of the composite primary endpoint (cardiovascular (CV) death, non-fatal myocardial infarction, ischemic stroke) at 24 weeks in prasugrel patients was 9.4 percent, while 11.8 percent in clopidogrel patients (RR*=23 percent). |
| 2013-03-14 | Daiichi Sankyo | Results Daiichi Sankyo Announces Results of PRASFIT-Elective Study Regarding Use of Prasugrel in Elective Patients with Stable Angina and Chronic Myocardial Infarction Undergoing PCI daiichisankyo.com ↗
The follow-up period for this study has been completed and the anticipated data was obtained. |
| 2012-10-23 | Eli Lilly and Company | Results New Retrospective Studies of Hospital Readmission Rates for Subsequent Heart Attack and Initial Hospitalization Costs in ACS-PCI Patients Treated with Effient® (Prasugrel) or Plavix® (Clopidogrel) Presented at TCT lilly.com ↗
Effient-treated patients (n=9,404) had a significantly lower adjusted rate of rehospitalization for AMI than Plavix-treated patients (n=74,163) at 30 days (Odds Ratio [OR]: 0.89; p=0.047) and 90 days (OR: 0.90; p= 0.037) following ACS-PCI discharge. |
| 2012-09-21 | Daiichi Sankyo | Results Daiichi Sankyo Announces PRASFIT-ACS Results Regarding Prasugrel in Acute Coronary Syndrome Patients Undergoing PCI daiichisankyo.com ↗
The follow-up period for this study has been completed and the anticipated data was obtained. |
| 2012-08-26 | Daiichi Sankyo | Results Daiichi Sankyo and Lilly Announce TRILOGY ACS Results Regarding Effient(R) (Prasugrel) in Acute Coronary Syndrome UA/NSTEMI Patients to be Managed Medically without an Artery-Opening Procedure daiichisankyo.com ↗
This outcome was not statistically significant (P=0.21). |
| 2012-08-26 | Eli Lilly and Company | Results Daiichi Sankyo and Lilly Announce TRILOGY ACS Results Regarding Effient® (Prasugrel) in Acute Coronary Syndrome UA/NSTEMI Patients to be Managed Medically without an Artery-Opening Procedure lilly.com ↗
At 30 months, 13.9 percent of prasugrel patients vs. 16.0 percent of clopidogrel patients experienced the combined primary endpoint of heart attack, stroke or cardiovascular (CV) death in patients under 75 years of age, the primary analysis population (HR=0.91; 95% CI: 0.79-1.05). |
| 2011-11-16 | Eli Lilly and Company | Results New Analysis of Data Presented at AHA Regarding Effect of Effient® (Prasugrel) on Cardiovascular Events in STEMI Patients According to Timing of PCI lilly.com ↗
TIMI major non-CABG bleeding events associated with prasugrel as compared to clopidogrel were consistent in the STEMI cohort compared to the overall trial. |
| 2010-11-16 | Eli Lilly and Company | Results Mortality Data Presented for Patients Treated with Effient® Who Underwent Isolated Coronary Artery Bypass Surgery lilly.com ↗
New results from an observational substudy from TRITON—TIMI 38 presented today at the American Heart Association (AHA) Scientific Sessions annual meeting showed that patients treated with Effient® (prasugrel) prior to coronary artery bypass graft surgery (CABG) had a reduced overall mortality rate compared to patients treated with Plavix® (clopidogrel) (2.3 percent versus 8.7 percent respectively, p=0.016). |
| 2010-09-13 | Eli Lilly and Company | Results Phase II Study Showed Switching ACS-PCI Patients to Effient(R)/aspirin from Plavix(R)/aspirin Regimen Reduced Maximum Platelet Aggregation After One Week lilly.com ↗ |
| 2010-03-15 | Eli Lilly and Company | Results New Analysis Assesses Impact of Common Genetic Variation on Benefit of Antiplatelet Therapy lilly.com ↗
In contrast, Effient-treated patients with two C3435T variants (n=390) did not have a statistically significant increased risk of e |
| 2010-01-05 | Eli Lilly and Company | Results New Analysis Showed Effient(R) Cost-Effective Compared with Clopidogrel for Patients with Acute Coronary Syndromes Undergoing PCI lilly.com ↗
In the pre-specified analysis of 6,705 patients, treatment with Effient compared with clopidogrel reduced total hospitalization costs over approximately 15 months, not including the cost of study drugs, by $530 per patient. |
| 2009-11-15 | Eli Lilly and Company | Results Efient(R) Exhibited Greater Antiplatelet Activity than High Dose Clopidogrel in Type 2 Diabetes Mellitus Patients with Coronary Artery Disease lilly.com ↗
In addition, one hour after the loading dose, patients who received prasugrel had 50 percent IPA compared with 13 percent in patients who received clopidogrel. |
| 2009-11-15 | Eli Lilly and Company | Results Effient(R) Exhibited Greater Antiplatelet Activity than High Dose Clopidogrel in Type 2 Diabetes Mellitus Patients with Coronary Artery Disease lilly.com ↗
In addition, one hour after the loading dose, patients who received Effient had 50 percent IPA compared with 13 percent in patients who received clopidogrel. |
| 2009-07-11 | Daiichi Sankyo | Regulatory Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient™ daiichisankyo.com ↗
Daiichi Sankyo, Inc. and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved Effient™(prasugrel) tablets for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with an artery-opening procedure known as percutaneous coronary intervention (PCI). |
| 2009-07-10 | Eli Lilly and Company | Regulatory Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient(TM) lilly.com ↗ |
| 2009-05-21 | Eli Lilly and Company | Results Multiple Types of Heart Attacks Reduced by Prasugrel in TRITON-TIMI 38 Trial lilly.com ↗
In this post hoc analysis, the incidence of non-procedural heart attack in patients treated with prasugrel compared with patients treated with clopidogrel was 2.8 percent vs. 3.7 percent, respectively (p=0.0013). |
| 2009-05-05 | Eli Lilly and Company | Results New Analysis Evaluated Impact of Genetic Variation on Response to Prasugrel lilly.com ↗
Our findings showed that variation in the CYP2C19 gene did not appear to influence the rate of cardiac events in patients treated with prasugrel in this study. |
| 2009-02-24 | Daiichi Sankyo | Regulatory European Commission Approves EFIENT®(prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI daiichisankyo.com ↗
European Commission Approves EFIENT®(prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI |
| 2009-02-23 | Eli Lilly and Company | Regulatory European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI lilly.com ↗
Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) announced today that the European Commission has granted marketing authorization for EFIENT(R) (pronounced Ef-ee-ent) (prasugrel) for the prevention of atherothrombotic events in patients with ACS undergoing percutaneous coronary intervention (PCI). |
| 2009-02-04 | Daiichi Sankyo | Regulatory Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee daiichisankyo.com ↗
The U.S. Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 that prasugrel, an investigational antiplatelet agent should be approved for the treatment of patients with acute coronary syndromes (ACS) managed with an artery-opening procedure known as percutaneous coronary intervention (PCI), Daiichi Sankyo Company, Limited, (TSE: 4568), and Eli Lilly and Company (NYSE: LLY) announced today. |
| 2009-02-03 | Eli Lilly and Company | Regulatory Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee lilly.com ↗
The Advisory Committee voted unanimously that prasugrel should be approved for the treatment of patients with acute coronary syndromes undergoing PCI. |
| 2008-12-19 | Daiichi Sankyo | Regulatory Prasugrel Receives Positive Opinion from the European Committee for Medicinal Products for Human Use (CHMP) daiichisankyo.com ↗ |
| 2008-12-18 | Eli Lilly and Company | Regulatory Prasugrel Receives Positive Opinion from the European Committee for Medicinal Products for Human Use (CHMP) lilly.com ↗
The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union. |
| 2008-09-27 | Daiichi Sankyo | Regulatory FDA Continues to Review Prasugrel New Drug Application daiichisankyo.com ↗ |
| 2008-09-26 | Eli Lilly and Company | Regulatory FDA Continues to Review Prasugrel New Drug Application lilly.com ↗
Daiichi Sankyo Company, Limited, (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) confirmed today that the U.S. Food and Drug Administration (FDA) did not complete its review for the prasugrel new drug application (NDA) by the Prescription Drug User Fee Act goal date of September 26, 2008. |
| 2008-09-03 | Eli Lilly and Company | Results Prasugrel Significantly Reduced New or Recurrent Heart Attacks in Both Acute and Longer-Term Settings Following PCI, Compared with Clopidogrel lilly.com ↗
Long-term treatment with prasugrel, continuing after 30 days for up to 15 months, significantly reduced the risk for patients who suffer any form of heart attack by 23 percent compared with clopidogrel (2.9 percent vs. 3.7 percent, p=0.01). |
| 2008-09-03 | Eli Lilly and Company | Results New Crossover Study Shows Prasugrel Significantly Reduced Platelet Aggregation in Patients with Acute Coronary Syndromes Compared with Clopidogrel at High Doses lilly.com ↗
Results of this study, known as the ACAPULCO(1) trial, showed that the 10 mg prasugrel maintenance dose significantly reduced the level of maximum platelet aggregation by 12.9 percent compared to the 150 mg clopidogrel maintenance dose (P<0.001). |
| 2008-08-31 | Eli Lilly and Company | Results Prasugrel Head-to-Head Study Showed Reduced Cardiovascular Events in Diabetes Patients by 30 Percent Compared with Clopidogrel lilly.com ↗
In addition, according to this same analysis, the combined rate of cardiovascular death, non-fatal heart attack and non-fatal stroke was reduced by 30 percent in diabetes patients treated with prasugrel compared to those treated with clopidogrel (12.2 percent vs. 17.0 percent, P<0.001). |
| 2008-08-25 | Daiichi Sankyo | Results Head-to-Head Study Showed Prasugrel Statistically Superior to Clopidogrel in Reducing Recurrent Cardiovascular Events daiichisankyo.com ↗
New analysis of landmark study showed patients taking prasugrel had lower risk of combined endpoint of recurrent heart attack, stroke or cardiovascular death after first event than those taking clopidogrel |
| 2008-08-21 | Eli Lilly and Company | Results Head-to-Head Study Showed Prasugrel Statistically Superior to Clopidogrel in Reducing Recurrent Cardiovascular Events lilly.com ↗
The reduction in recurrent events among prasugrel patients persisted over the duration of the trial (15 months). |
| 2008-06-24 | Daiichi Sankyo | Regulatory FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel daiichisankyo.com ↗
This three month extension allows the FDA time to complete its review. |
| 2008-06-23 | Eli Lilly and Company | Regulatory FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel lilly.com ↗
This three month extension allows the FDA time to complete its review. |
| 2008-03-31 | Daiichi Sankyo | Results Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel daiichisankyo.com ↗
Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel |
| 2008-03-29 | Eli Lilly and Company | Results Study Results Show Investigational Drug, Prasugrel, Cuts Risk of Stent-Related Clots by More than Half Versus Clopidogrel lilly.com ↗
Prasugrel reduced the relative risk of coronary stent thrombosis (a new clot at the implanted stent site) over clopidogrel by 52 percent (1.13 percent vs. 2.35 percent, p0.0001). |
| 2008-02-22 | Daiichi Sankyo | Regulatory FDA grants priority review for Daiichi Sankyo, Lilly drug, prasugrel Investigational antiplatelet agent submitted for treatment of patients with acute coronary syndrome being managed with percutaneous coronary intervention daiichisankyo.com ↗
FDA grants priority review for Daiichi Sankyo, Lilly drug, prasugrel |
| 2008-02-21 | Eli Lilly and Company | Regulatory FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel lilly.com ↗ |
| 2008-02-20 | Daiichi Sankyo | Regulatory Daiichi Sankyo, Lilly Submit Marketing Authorization Application for Investigational Oral Antiplatelet Drug, Prasugrel, to European Medicines Agency daiichisankyo.com ↗
Daiichi Sankyo, Lilly Submit Marketing Authorization Application for Investigational Oral Antiplatelet Drug, Prasugrel, to European Medicines Agency |
| 2008-01-07 | Daiichi Sankyo | Regulatory Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration If Approved for Marketing in the United States, Trade Name Will be Effient™ daiichisankyo.com ↗ |
| 2008-01-04 | Eli Lilly and Company | Regulatory Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration lilly.com ↗
Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) today announced that on Wednesday, Dec. 26, 2007, they submitted a New Drug Application (NDA) for prasugrel to the U.S. Food and Drug Administration (FDA). |
| 2007-11-04 | Daiichi Sankyo | Results In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack daiichisankyo.com ↗
A significant reduction in the risk for the composite endpoint favoring prasugrel (60 mg loading dose/10 mg maintenance dose) over clopidogrel (300 mg LD/75 mg MD) was observed as early as three days. |
| 2007-11-04 | Eli Lilly and Company | Results In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack lilly.com ↗
A significant reduction in the risk for the composite endpoint favoring prasugrel (60 mg loading dose/10 mg maintenance dose) over clopidogrel (300 mg LD/75 mg MD) was observed as early as three days. |
| 2007-10-25 | Daiichi Sankyo | Results Study Protocols Will be Amended in Two Small Early-Phase Prasugrel Studies daiichisankyo.com ↗ |
| 2007-10-24 | Eli Lilly and Company | Results Study Protocols Will be Amended in Two Small Early-Phase Prasugrel Studies lilly.com ↗
The amendments are due to preliminary results from pharmacokinetic analyses, including patients and healthy subjects/volunteers, indicating that a dose adjustment may be appropriate for certain subpopulations. |
| 2006-10-24 | Daiichi Sankyo | Results New Study Shows Prasugrel Achieves Faster Onset and Higher Levels of Platelet Inhibition than Clopidogrel at Approved or Higher Doses daiichisankyo.com ↗
Thirty minutes after oral administration, the level of platelet inhibition with a prasugrel 60 mg dose was significantly higher than observed with either loading dose of clopidogrel. |
| 2006-10-23 | Eli Lilly and Company | Results New Study Shows Prasugrel Achieves Faster Onset and Higher Levels of Platelet Inhibition than Clopidogrel at Approved or Higher Doses lilly.com ↗
Thirty minutes after oral administration, the level of platelet inhibition with a prasugrel 60 mg dose was significantly higher than observed with either loading dose of clopidogrel. |
| 2006-03-14 | Eli Lilly and Company | Results Study Shows More Potent and More Reliable Platelet Inhibition with Prasugrel Compared to Clopidogrel Even in Patients With More Reactive Platelets lilly.com ↗
In early phase data announced today, the investigational antiplatelet agent, prasugrel, demonstrated greater and more reliable antiplatelet effect compared to clopidogrel (Plavix(R)) even in patients with increased platelet reactivity. |
| 2005-03-09 | Eli Lilly and Company | Results Results of Early Data Show More Consistent Platelet Inhibition with Prasugrel Compared to Clopidogrel Across Three Distinct Trials lilly.com ↗
In three early- phase trials,(1,2,3) an investigational platelet inhibitor, prasugrel (CS-747, LY640315), demonstrated significantly higher and more consistent inhibition of platelet aggregation (IPA) compared to both placebo and the current standard of care, clopidogrel (Plavix(R)). |
All press releases naming this drug 72 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 201 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | prasugrel | “Randomization will be stratified by stent type (cobalt-chromium everolimus-eluting stents, platinum-chromium everolimus-eluting stents, and sirolimus-eluting stents with...” PMID 29447787 ↗ Dec 2017197“A total of 2268 STEMI patients indicated for primary PCI with current generation platinum‑chromium everolimus-eluting stents were randomized 1:1 to either prasugrel monotherapy...” PMID 41436299 ↗ Dec 2025 “Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice...” NCT00823212 ↗ “Every antiplatelet-naïve patient undergoing an elective procedure will be given 300 mg aspirin and loading dose of one of P2Y12 receptor inhibitors (e.g., 600 mg clopidogrel,...” NCT02601157 ↗ “Patients randomized to the antithrombotic monotherapy treatment receive any of the commercially available oral P2Y12 inhibitors (clopidogrel, ticagrelor, prasugrel) and...” NCT05955365 ↗ “Dual antiplatelet therapy with aspirin and either clopidogrel, prasugrel or ticagrelor will be recommended for 12 months duration in the Xience stent arm but only 4 months...” NCT02303717 ↗ “It consists in oral ingestion of 1.5g of paracetamol (Contents of 3 Doliprane® capsules 500 mg) and 60 mg prasugrel (6 tablets Efient ® 10 mg) or 180 mg ticagrelor ( 2 tablets...” NCT02251249 ↗ “Unlike prasugrel and ticagrelor, which are potent P2Y12 inhibitors, clopidogrel is activated in the liver via the cytochrome P450 2C19 (CYP2C19) metabolic pathway to exert its...” NCT06763744 ↗ “Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing...” NCT01852019 ↗ “Patients enrolled in dual antiplatelets at least 6 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for at least 6 months...” NCT04708587 ↗ “Treatment with clopidogrel 150mg once daily for a minimum of 10 days (max. 14 days), followed by a minimum of 10 days treatment with prasugrel 10mg once daily (max 14 days).” NCT05657041 ↗ |
| Known as | Effient | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201772 ↗ |
| Known as | EFFIENT (prasugrel) | “EFFIENT (prasugrel)” NCT01589978 ↗ |
| Known as | Efient | “It consists in oral ingestion of 1.5g of paracetamol (Contents of 3 Doliprane® capsules 500 mg) and 60 mg prasugrel (6 tablets Efient ® 10 mg) or 180 mg ticagrelor ( 2 tablets...” NCT02251249 ↗1“Group 2: Prasugrel (Efient)” NCT01339026 ↗ |
| Known as | Generic name: Prasugrel | “Generic name: Prasugrel” NCT01099566 ↗ |
| Known as | LY-640315 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201772 ↗ |
| Known as | NSC-759625 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201772 ↗ |
| Known as | Prasu doc | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201772 ↗ |
| Known as | Prasugrel (Effient) | “Prasugrel (Effient)” NCT01184300 ↗ |
| Known as | Prasugrel = EFIENT | “Prasugrel = EFIENT” NCT01493999 ↗ |
| Known as | PRASUGREL BESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201772 ↗ |
| Known as | Prasugrel hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201772 ↗ |
| Known as | Prasugrel Hydrochloride | “Prasugrel Hydrochloride 10 MG Oral Tablet” NCT04445623 ↗ |
| Known as | Prasugrel viatris (previously prasugrel mylan) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201772 ↗ |
| Action | Inhibit | “maintaining high levels of inhibition of platelet aggregation via P2Y(12) receptor inhibition” PMID 18498956 ↗ May 2008 |
| Modality | Small molecule | “Prasugrel, a new thienopyridine” PMID 17982182 ↗ Nov 2007 |
| Route | Oral | “Administered orally” NCT00059215 ↗ |
| Target | P2RY12 | “Recently, two new oral P2Y12 antagonists have been approved for clinical use: prasugrel, a third generation thienopyridine, and ticagrelor, a first in class...” NCT02016170 ↗ |