reteplase
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Rapilysin | — | 2024-01-26 | europa.eu ↗ |
| Approved | US (FDA) | RETAVASE | — | 1998-05-06 | fda.gov ↗ |
| Approved | EU (EMA) | Rapilysin | — | 1996-08-29 | europa.eu ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 25 trials · 1 missed | ||||||
| Phase 2 | NCT05900674 | Jul 2023 → Jul 2024 | ischemic stroke | Zeenat Qureshi Stroke Institute | Withdrawn | No outcome recorded |
| Phase 2 | NCT04110275 | Oct 2019 → May 2021 | pulmonary embolism | Angde Biotech Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04028518 | Jul 2019 → Oct 2020 | ischemic stroke | Angde Biotech Pharmaceutical Co., Ltd. | Unknown | Missed primary |
| Phase 2 | NCT00046293 | Sep 2002 → Jul 2007 | cerebral infarction | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00039832 | Mar 2002 → Apr 2007 | stroke disorder | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 37 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT06841965 | Mar 2025 → Jun 2027 expected | ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06841978 | Mar 2025 → Jun 2027 expected | ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06749834 | Jan 2025 → Dec 2026 expected | ischemic stroke | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 3 | NCT05295173 | Mar 2022 → Jun 2023 | ischemic stroke | Angde Biotech Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT04571580 | Jul 2021 → Jan 2023 | ST-elevation myocardial infarction | Ge Junbo | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00046228 | Aug 2002 → Jan 2008 | myocardial infarction | Centocor, Inc. | Completed | Missed primary |
| Phase 3 | NCT00245648 | Jun 2001 → Oct 2007 | myocardial infarction | NYU Langone Health | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06115070 | Mar 2025 → Dec 2027 expected | ischemic stroke, thrombotic disease | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT00178620 | Sep 2003 → Dec 2009 | acute myocardial infarction | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT00806403 Comparator | Nov 2001 → Jun 2003 | acute myocardial infarction | Sahlgrenska University Hospital | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | reteplase | “The GUSTO (Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes) V Investigators studied standard-dose reteplase vs standard-dose abciximab plus...” PMID 17954798 ↗ Oct 200714“Recombinant human tissue-type plasminogen activator derivative(rPA,chemical name: Reteplase,brand name:Ruitongli) 18mg/10ml/stick, provided by AngDe Biotech Pharmaceutical...” NCT04110275 ↗ “This clinical trial will determine an acceptable dose of reteplase in combination with a fixed dose of abciximab for ischemic stroke” NCT00046293 ↗ “intravenous reteplase (a bolus of 18 mg followed by a second bolus of 18 mg after 30 minutes)” NCT06841965 ↗ “intravenous reteplase (a bolus of 18 mg followed by a second bolus of 18 mg after 30 minutes)” NCT06115070 ↗ “intravenous reteplase (a bolus of 18 mg followed by a second bolus of 18 mg after 30 minutes)” NCT06749834 ↗ “Reteplase is a more affordable new-generation thrombolytic with a prolonged half-life.” PMID 38152962 ↗ Dec 2023 “Reteplase versus Alteplase for Acute Ischemic Stroke.” PMID 42089199 ↗ May 2026 “intravenous reteplase (a bolus of 18 mg” NCT06841978 ↗ |
| Known as | RETAVASE | “This study will evaluate the safety and effectiveness of two types of blood thinners, abciximab (ReoPro) and reteplase (Retavase) for restoring normal brain blood flow after...” NCT00039832 ↗1“The study aims to evaluate third-generation thrombolytic - RETAVASE® (reteplase) and compare it to IV alteplase, in acute ischemic stroke patients.” NCT05900674 ↗ |
| Known as | rPA | “Recombinant human tissue-type plasminogen activator derivative(rPA,chemical name: Reteplase,brand name:Ruitongli) 18mg/10ml/stick, provided by AngDe Biotech Pharmaceutical...” NCT04110275 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant Human Tissue Plasminogen Kinase Derivative for Injection” NCT04028518 ↗ |
| Route | Intravenous | “Retavase is administered in a single dose through a needle in the vein over 2 minutes.” NCT00039832 ↗ |