Drugs / Argatroban
Argatroban
also known as
Argatra · Acova · Argatroban anhydrous · Argatroban hydrate · Argatroban in dextrose · Argatroban in sodium chloride · Argatroban monohydrate · Argipidine · +5 more
Small molecule targets F2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed heparin-induced thrombocytopenia 1 milestone | |||||
| Filed | UK (MHRA) | — | heparin-induced thrombocytopenia | — | “MPE filed in the UK an application for approval of argatroban as a therapeutic for heparin-induced thrombocytopenia (HIT) type II” tanabe-pharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansions (2) | US (FDA) | ARGATROBAN | — | 2002-04-03 – 2008-05-05 | fda.gov ↗ |
| Approved | US (FDA) | ARGATROBAN | — | 2000-06-30 | fda.gov ↗ |
Trials 29
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05325346 | Mar → Apr 2022 | heparin-induced thrombocytopenia | Veralox Therapeutics | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00268762 | Feb 2003 → Aug 2010 | ischemic stroke | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT07499037 | Jan 2027 → Sep 2029 expected | heart failure, pneumonia | University Hospital Ostrava | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05033964 | Dec 2021 → Dec 2022 overdue | coronary artery disorder | Elixir Medical Corporation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02448069 | May 2015 → Aug 2016 | brain ischemia, stroke disorder | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2 | NCT01911624 | Jan 2013 → Apr 2016 | staphylococcus aureus infection | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 2 | NCT01734252 | Jul 2012 → Apr 2016 | hyperheparinemia | Medical University Innsbruck | Completed | Mixed |
| Phase 2 | NCT01464788 | Oct 2011 → Jun 2015 | ischemic stroke | Andrew D. Barreto, MD | Terminated | No outcome recorded |
| Phase 2 | NCT00861692 | Apr 2009 → Feb 2011 | heparin-induced thrombocytopenia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00508924 | Aug 2005 → Oct 2006 | intermediate coronary syndrome | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05226442 | Dec 2021 → Jul 2024 | blood coagulation disease | Medical University of Vienna | Completed | No outcome recorded |
| Phase 33 trials · 1 missed | ||||||
| Phase 3 | NCT03735979 | Oct 2019 → Dec 2023 | ischemic stroke | Washington University School of Medicine | Completed | Missed primary |
| Phase 3 | NCT02935530 | Jan 2016 → Aug 2017 | female reproductive system neoplasm, venous thromboembolism | Huazhong University of Science and Technology | Completed | No outcome recorded |
| Phase 3 | NCT00198588 | Jun 2005 → Jul 2006 | heparin-induced thrombocytopenia | Ministry of Health, Labour and Welfare, Japan | Completed | No outcome recorded |
| Phase 413 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT06442267 | Jul 2024 → Jan 2027 expected | hemorrhagic disease, respiratory failure, thrombotic disease | Medical University of Vienna | Recruiting | No outcome recorded |
| Phase 4 | NCT04406389 | Oct 2020 → Apr 2021 | COVID-19 | Weill Medical College of Cornell University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04275180 | Mar 2020 → Jul 2022 | ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Completed | Met primary |
| Phase 4 | NCT03740958 | Dec 2018 → Jan 2022 | ischemic stroke | General Hospital of Shenyang Military Region | Completed | Missed primary |
| Phase 4 | NCT03506009 | Jul → Nov 2018 | — | Huisheng Chen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03552354 | Oct 2017 → Oct 2018 | ischemic stroke | General Hospital of Shenyang Military Region | Completed | No outcome recorded |
| Phase 4 | NCT05740371 | Apr 2017 → May 2021 | intermediate coronary syndrome | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 4 | NCT01246011 | Nov 2010 → Jul 2011 | — | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01163604 | Aug 2010 → Dec 2013 | cardiovascular disorder | Jinling Hospital, China | Completed | No outcome recorded |
| Phase 4 | NCT01980316 | Apr 2010 → Aug 2011 | cardiovascular disorder | Xinfeng Liu | Completed | No outcome recorded |
| Phase 4 | NCT00787332 | Sep 2008 → Dec 2009 | heparin-induced thrombocytopenia | Canyon Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00039858 | Sep 2003 → Mar 2006 | thrombocytopenia, thrombotic disease | Encysive Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00035178 | May → Nov 2002 | chronic renal failure syndrome, end stage renal failure | Texas Biotechnology Corporation | Completed | No outcome recorded |
| Phase not applicable2 trials · 1 missed | ||||||
| — | NCT04925167 | Jul 2021 → Dec 2023 | respiratory failure | Beijing Chao Yang Hospital | Completed | No outcome recorded |
| — | NCT04202549 | Dec 2019 → Sep 2022 | ischemic stroke | Huisheng Chen | Completed | Missed primary |
| Comparator or background therapy3 trials | ||||||
| Phase 3 | NCT03809481 Comparator | May 2019 → Jun 2022 | heparin-induced thrombocytopenia | Aspen Global Incorporated | Terminated | No outcome recorded |
| Phase 4 | NCT00798525 Comparator | Jan 2009 → Mar 2012 | heparin-induced thrombocytopenia | Heinrich-Heine University, Duesseldorf | Terminated | No outcome recorded |
| Phase 4 | NCT00603824 Comparator | Jan 2008 → Jul 2009 | heparin-induced thrombocytopenia | Methodist Healthcare - Memphis | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2011-05-20 | Tanabe Pharma Corporation | Regulatory Approval for Additional Indications for the Selective Antithrombin Agents, Novastan® HI Injection 10 mg/2mL and Slonnon® HI Injection 10 mg/2mL tanabe-pharma.com ↗
Approval for Additional Indications for the Selective Antithrombin Agents, Novastan® HI Injection 10 mg/2mL and Slonnon® HI Injection 10 mg/2mL |
All press releases naming this drug 9 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | argatroban | “The PK sub-study is being conducted to assess the blood pharmacokinetics of the three drugs (Sirolimus, Rivaroxaban, Argatroban) eluted from the DESyne BDS Plus after implantation.” NCT05033964 ↗31“Intra-arterial administration of argatroban (0.2-0.3 mg/min), dexamethasone (0.1 mg/min) and edaravone (0.3 mg/min) for 30 to 60 minutes after thrombectomy” NCT04202549 ↗ “dabigatran 110 mg BID, po argatroban (0.5 - 1 µg/kg/min) if peroral therapy is not possible” NCT01911624 ↗ |
| Known as | Acova | ChEMBL registry synonym — accepted as the source's own label CHEMBL1166 ↗ |
| Known as | Argatra | “A Pilot Trial to Assess the Efficacy of Argatroban (Argatra®) in Critically Ill Patients With Heparin Resistance” NCT01734252 ↗1“Patients treated with Argatroban (Argatra®), a direct thrombin inhibitor” NCT00798525 ↗ |
| Known as | Argatroban anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL1166 ↗ |
| Known as | Argatroban hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1166 ↗ |
| Known as | Argatroban in dextrose | ChEMBL registry synonym — accepted as the source's own label CHEMBL1166 ↗ |
| Known as | Argatroban in sodium chloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL1166 ↗ |
| Known as | Argatroban monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1166 ↗ |
| Known as | Argipidine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1166 ↗ |
| Known as | DK-7419 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1166 ↗ |
| Known as | GN-1600 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1166 ↗ |
| Known as | MCI-9038 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1166 ↗ |
| Known as | MD-805 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1166 ↗ |
| Known as | Novastan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1166 ↗ |
| Action | Inhibit | “Argatroban is a direct thrombin inhibitor that safely augments recanalization achieved by tissue-type plasminogen activator (tPA) in animal stroke models.” PMID 22223235 ↗ Jan 20121“Thrombin inhibitor” CHEMBL1166 ↗ |
| Modality | Small molecule | “The synthetic arginine-derived direct thrombin inhibitor argatroban is an attractive anticoagulant for percutaneous coronary intervention (PCI), because of its rapid onset and...” PMID 20226548 ↗ Mar 2010 |
| Route | Intravenous | “Argatroban IV Infusion at 1mcg/kg/min for 48 hours.” NCT00268762 ↗ |
| Target | F2 | “Thrombin inhibitor” CHEMBL1166 ↗ |