Drugs / Tirofiban
Tirofiban
also known as
Tirofiban Hydrochloride · Aggrastat · Agrastat · brand name of tirofiban: Xinweining · L-700,462 · MK-383 · Tirofiban hcl · Tirofiban hydrochloride anhydrous · +1 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acute coronary syndrome 1 milestone | |||||
| Filed | US (FDA) | AGGRASTAT | acute coronary syndrome | 2013-01-08 | “sNDA for the high dose bolus (HDB) dosing regimen of AGGRASTAT ® (tirofiban HCl) has been submitted to the United States Food and Drug Administration (FDA).” medicure.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | AGGRASTAT | — | 2013-10-10 | fda.gov ↗ |
| Approved | US (FDA) | AGGRASTAT | — | 1998-05-14 | fda.gov ↗ |
Trials 51
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03078257 | Jan 2016 → Nov 2017 | coronary artery disorder | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 1 | NCT01766154 | Jan → Feb 2013 | impaired renal function disease | Medicure | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07493577 | Jul 2026 → Jan 2029 expected | acquired aneurysmal subarachnoid hemorrhage | Dr David Hasan, M.D. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT04818944 | Mar 2023 → Jan 2025 | ischemic stroke | University of Iowa | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03691727 | Jan 2019 → Jul 2020 | acquired aneurysmal subarachnoid hemorrhage | David Hasan | Completed | No outcome recorded |
| Phase 24 trials · 2 met primary | ||||||
| Phase 2 | NCT05188417 | Dec 2021 → Mar 2023 | ischemic stroke | GrandPharma (China) Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04851457 | Apr 2021 → Jul 2023 | ischemic stroke | Shanghai East Hospital | Completed | Met primary |
| Phase 2 | NCT04368377 | Apr 2020 | COVID-19, respiratory failure, thrombotic disease, viral pneumonia | University of Milan | Completed | No outcome recorded |
| Phase 2 | NCT01522417 | Apr 2012 → Dec 2018 | acute coronary syndrome, intermediate coronary syndrome, myocardial infarction | Medicure | Completed | Met primary |
| Phase 2/38 trials · 2 met primary | ||||||
| Phase 2/3 | NCT07842185 | Nov 2026 → Dec 2030 expected | ischemic stroke | Xinqiao Hospital of Chongqing | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06587347 | Nov 2024 → Jun 2026 overdue | cerebral infarction | Capital Medical University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06373042 | Jul 2024 → Jul 2026 overdue | ischemic stroke | Zhongming Qiu | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06265051 | Apr 2024 → Dec 2025 | ischemic stroke, vascular occlusion disorder | Xiang Luo | Completed | Met primary |
| Phase 2/3 | NCT06238115 | Mar 2024 → Oct 2025 | intracranial berry aneurysm, thrombotic disease | Beijing Tiantan Hospital | Completed | Met primary |
| Phase 2/3 | NCT05728333 | Nov 2023 → May 2026 | ischemic stroke | Xinqiao Hospital of Chongqing | Completed | No outcome recorded |
| Phase 2/3 | NCT04491695 | Sep 2020 → Dec 2022 | stroke disorder | Capital Medical University | Unknown | No outcome recorded |
| Phase 2/3 | NCT03357133 | Dec 2017 → Jun 2020 | ischemic stroke | Capital Medical University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 313 trials · 2 met primary | ||||||
| Phase 3 | NCT07818083 | Sep 2026 → Sep 2028 expected | acquired aneurysmal subarachnoid hemorrhage, brain aneurysm | First Affiliated Hospital of Fujian Medical University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07379190 | Jun 2026 → Feb 2029 expected | cerebral infarction | Weifang Medical University | Recruiting | No outcome recorded |
| Phase 3 | NCT07537933 | Apr 2026 → Apr 2028 expected | cerebral artery occlusion, ischemic stroke | Shandong Provincial Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07335107 | Jan 2026 → Jan 2027 expected | ischemic stroke | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07111806 | Dec 2025 → Dec 2028 expected | ischemic stroke | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07135089 | Nov 2025 → Sep 2027 expected | ischemic stroke | General Hospital of Shenyang Military Region | Recruiting | No outcome recorded |
| Phase 3 | NCT06319846 | Jul 2024 → Oct 2025 overdue | cerebral artery stenosis, transient ischemic attack | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05604638 | Apr 2024 → Dec 2025 overdue | ischemic stroke | Second Affiliated Hospital of Guangxi Medical University | Recruiting | Met primary |
| Phase 3 | NCT06134622 | Mar → Sep 2024 | ischemic stroke | The First Affiliated Hospital of University of Science and Technology of China | Completed | Met primary |
| Phase 3 | NCT06037889 | Nov 2023 → Feb 2026 | cerebral atherosclerosis | Peking Union Medical College Hospital | 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 | NCT01109134 | Sep 2008 → Feb 2009 | acute myocardial infarction | Kosuyolu Heart Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01245725 | — | acute coronary syndrome, intermediate coronary syndrome, myocardial infarction | Medicure | Withdrawn | No outcome recorded |
| Phase 417 trials · 2 met primary · 2 missed | ||||||
| Phase 4 | NCT05225961 | Mar 2026 | ischemic stroke | Andalusian Public Foundation for Health Research in Seville | Completed | No outcome recorded |
| Phase 4 | NCT07290751 | Nov 2025 → Oct 2026 expected | ischemic stroke | Beijing Anzhen Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07095790 | Aug 2025 → Feb 2027 expected | stroke disorder | Second Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 4 | NCT05841147 | Apr → Jul 2023 | brain aneurysm | Lu Hua | Unknown | No outcome recorded |
| Phase 4 | NCT05310968 | Nov 2022 → Feb 2025 | cerebral atherosclerosis | Beijing Tiantan Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03797729 | May 2019 → Jun 2021 | ST-elevation myocardial infarction | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02592694 | Oct 2015 → Oct 2017 | ST-elevation myocardial infarction | Xijing Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02592720 | Oct 2015 → Oct 2017 | acute coronary syndrome | Xijing Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02294994 | Nov 2014 → Dec 2016 | coronary artery disorder | Second Hospital of Jilin University | Unknown | No outcome recorded |
| Phase 4 | NCT03114995 | Feb 2012 → Oct 2015 | myocardial infarction | Seoul National University Bundang Hospital | Completed | Missed primary |
| Phase 4 | NCT01498003 | Nov 2011 → Jun 2014 | coronary artery disorder | Shanghai Jiao Tong University School of Medicine | Completed | Met primary |
| Phase 4 | NCT00407771 | Nov 2007 → Dec 2008 | coronary artery disorder | Jordan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00445263 | Mar 2007 → Dec 2010 | coronary artery disorder | Hospital Avicenne | Terminated | No outcome recorded |
| Phase 4 | NCT00398463 | May 2006 → Jul 2008 | — | Università degli Studi di Ferrara | Completed | Met primary |
| Phase 4 | NCT00300833 | Jan 2006 → Jan 2012 | acute myocardial infarction | The Baruch Padeh Medical Center, Poriya | Unknown | No outcome recorded |
| Phase 4 | NCT00611169 | Jan 2006 → Feb 2007 | acute myocardial infarction | Samsung Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00383136 | Jun 2003 → Sep 2007 | acute myocardial infarction | University of Bologna | Completed | Missed primary |
| Phase not applicable4 trials | ||||||
| — | NCT07026318 | Aug 2025 → Mar 2027 expected | ischemic stroke | Beijing Anzhen Hospital | Recruiting | No outcome recorded |
| — | NCT06966674 | May → Oct 2025 overdue | ST-elevation myocardial infarction | Kafrelsheikh University | Recruiting | No outcome recorded |
| — | NCT03406832 | Jan 2018 → Jun 2019 | ST-elevation myocardial infarction | The First Affiliated Hospital of Zhengzhou University | Unknown | No outcome recorded |
| — | NCT03406819 | Jan → Dec 2018 | ST-elevation myocardial infarction, strictly posterior acute myocardial infarction | The First Affiliated Hospital of Zhengzhou University | Unknown | No outcome recorded |
| Comparator or background therapy16 trials | ||||||
| Phase 1/2 | NCT04111289 Comparator | Nov 2019 → Sep 2021 | — | Assiut University | Unknown | No outcome recorded |
| Phase 2 | NCT01103440 Comparator | Apr 2007 → Jun 2009 | — | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 3 | NCT01660373 Comparator | Aug 2012 → Aug 2013 | acute coronary syndrome | Pusan National University Yangsan Hospital | Unknown | Missed primary |
| Phase 3 | NCT01336348 Comparator | Apr 2010 → Jun 2011 | ST-elevation myocardial infarction | Università degli Studi di Ferrara | Completed | No outcome recorded |
| Phase 3 | NCT00251576 Background | Nov 1999 → Mar 2004 | acute coronary syndrome | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT06769256 Comparator | Jan 2025 → Dec 2027 expected | ST-elevation myocardial infarction | Henan Institute of Cardiovascular Epidemiology | Recruiting | No outcome recorded |
| 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 | NCT02739711 Comparator | Jul 2016 → May 2024 | acute myocardial infarction | University of Luebeck | Unknown | No outcome recorded |
| Phase 4 | NCT02131220 Comparator | Nov 2015 → Aug 2017 | myocardial infarction | Fudan University | Completed | No outcome recorded |
| Phase 4 | NCT01696110 Comparator | Aug 2012 → Jul 2013 | acute myocardial infarction | Shenyang Northern Hospital | Completed | Met primary |
| Phase 4 | NCT02054000 Comparator | Jan 2011 → Dec 2013 | — | TC Erciyes University | Completed | No outcome recorded |
| Phase 4 | NCT00566891 Comparator | Dec 2007 → Jul 2008 | coronary artery disorder | S. Anna Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00538317 Comparator | Jul 2007 → Nov 2008 | acute myocardial infarction | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 4 | NCT00790387 Comparator | Jun 2004 → Dec 2005 | acute coronary syndrome | The Prince Charles Hospital | Completed | No outcome recorded |
| — | NCT06045156 Comparator | Apr 2024 → Jan 2026 overdue | ischemic stroke | The First Hospital of Jilin University | Recruiting | No outcome recorded |
| — | NCT05902000 Background | Jun 2023 → Jun 2025 | occlusion precerebral artery, stroke disorder | Xueli Cai | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2021-11-04 | Medicure | Results Medicure Announces that the Shortened AGGRASTAT® Versus INTEGRILIN® in Percutaneous Coronary Intervention (SAVI-PCI) Study has Met its Primary Endpoint medicure.com ↗
Medicure Announces that the Shortened AGGRASTAT® Versus INTEGRILIN® in Percutaneous Coronary Intervention (SAVI-PCI) Study has Met its Primary Endpoint |
| 2020-08-24 | Medicure | Results Medicure Announces AGGRASTAT® Shows Promise in Treating Thrombotic Complications Due to COVID-19 in Early Clinical Reports medicure.com ↗
Treated patients experienced a mean reduction in alveolar-arterial oxygen gradient and an increase in PaO 2 /FiO 2 (ratio of partial arterial pressure of oxygen to fraction of inspired oxygen) at 24h, 48h and 7 days after treatment. |
| 2020-06-29 | Medicure | Results Medicure Announces Positive Results for AGGRASTAT® in the FABOLUS-FASTER Trial and Publication in the Journal - Circulation medicure.com ↗
Medicure Inc. (" Medicure " or the " Company ") (TSXV: MPH) (OTC: MCUJF), a pharmaceutical company, today announced that results from the investigator sponsored FABOLUS-FASTER Phase 4 clinical trial, using AGGRASTAT ® , have been published in Circulation, a peer-reviewed journal of the American Heart Association. |
| 2016-09-01 | Medicure | Regulatory FDA Approves New AGGRASTAT® Product Format medicure.com ↗
Medicure Inc. (" Medicure " or the " Company ") (TSXV:MPH, OTC:MCUJF), a specialty pharmaceutical company, announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its new "bolus vial" product format for AGGRASTAT ® (tirofiban HCl). |
| 2016-07-07 | Medicure | Regulatory Medicure Receives Response Letter from FDA on AGGRASTAT® sNDA for New Indication medicure.com ↗
The FDA issued a Complete Response Letter to communicate that its initial review of the application is complete; however, it cannot approve the application in its present form and requested additional information. |
| 2016-05-11 | Medicure | Regulatory Medicure Files Application for New AGGRASTAT® Product Format medicure.com ↗
it has submitted an application to the U.S. Food and Drug Administration (FDA) for the introduction of a new "bolus vial" product format for AGGRASTAT (tirofiban HCl). |
| 2016-02-23 | Medicure | Results Meta-Analysis of AGGRASTAT® (Tirofiban HCl) Presented at CRT 2016 Conference medicure.com ↗
Results of the analysis found that HDB tirofiban had a significant reduction in all-cause mortality when compared with both heparin and eptifibatide (Integrilin ® , Merck & Co., Inc.) (p<0.05). |
| 2015-12-02 | Medicure | Regulatory Medicure Announces PDUFA Action Date for New Aggrastat Indication medicure.com ↗
the U.S. Food and Drug Administration ("FDA") has assigned a Prescription Drug User Fee Act ("PDUFA") action date of July 10, 2016 |
| 2015-09-10 | Medicure | Regulatory Medicure Announces Filing of sNDA for New AGGRASTAT® Indication medicure.com ↗
Medicure Announces Filing of sNDA for New AGGRASTAT® Indication |
| 2015-04-23 | Medicure | Regulatory Medicure Announces Approval of Expanded Dosing Time For AGGRASTAT® medicure.com ↗
The newly approved labeling supplement now allows the delivery duration of the AGGRASTAT high-dose bolus (25 mcg/kg) to occur anytime within 5 minutes, instead of the previously specified duration of 3 minutes. |
| 2013-10-11 | Medicure | Regulatory Medicure Announces Approval of Recommended Dosing Regimen for AGGRASTAT® medicure.com ↗ |
| 2013-01-08 | Medicure | Regulatory Medicure Announces Filing of sNDA for AGGRASTAT Label Change medicure.com ↗ |
All press releases naming this drug 18 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 68 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tirofiban | “Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration” NCT02592694 ↗65“Patients in the treatment group (n = 62) received eptifibatide (n = 41) or tirofiban (n = 21).” PMID 39217605 ↗ Dec 2024 “Tirofiban is a platelet glycoprotein IIb/IIIa receptor antagonist” NCT06373042 ↗ “Tirofiban is used as an adjunct to endovascular therapy.” NCT05902000 ↗ “cocktail (tirofiban, bivalirudin, tenecteplase)” NCT02592720 ↗ “Tirofiban” NCT01103440 ↗ |
| Known as | Aggrastat | “Tirofiban (Aggrastat) will be dosed as a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a percutaneous coronary intervention plus two hours after the procedure.” NCT01245725 ↗1“tirofiban hydrochloride (AGGRASTAT®)” NCT03691727 ↗ |
| Known as | Agrastat | “tirofiban (Agrastat®)” NCT00445263 ↗ |
| Known as | brand name of tirofiban: Xinweining | “brand name of tirofiban: Xinweining” NCT01696110 ↗ |
| Known as | L-700,462 | ChEMBL registry synonym — accepted as the source's own label CHEMBL916 ↗ |
| Known as | MK-383 | ChEMBL registry synonym — accepted as the source's own label CHEMBL916 ↗ |
| Known as | Tirofiban hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL916 ↗ |
| Known as | Tirofiban Hydrochloride | “tirofiban hydrochloride (AGGRASTAT®)” NCT03691727 ↗ |
| Known as | Tirofiban hydrochloride anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL916 ↗ |
| Known as | Tirofiban hydrochloride monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL916 ↗ |
| Action | Inhibit | “Tirofiban is another potent inhibitor of GP IIb/IIIa platelet receptor” NCT00383136 ↗ |
| Modality | Other / unclassified | “glycoprotein inhibitor, Tirofiban” NCT00407771 ↗ |
| Route | Intravenous | “intravenous infusion” NCT00445263 ↗ |