Drugs / reteplase

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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Withdrawn EU (EMA) Rapilysin 2024-01-26 europa.eu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 16 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 25 trials
Phase 2 NCT05900674 Jul 2023 → Jul 2024 ischemic stroke Zeenat Qureshi Stroke Institute Withdrawn No outcome recorded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 No outcome recorded
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 39 trials
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 No outcome recorded
Phase 3 NCT03992443 Feb → Mar 2022 Chiesi Farmaceutici S.p.A. Withdrawn No outcome recorded
Phase 3 NCT04571580 Jul 2021 → Jan 2023 ST-elevation myocardial infarction Ge Junbo Terminated No outcome recorded
Phase 3 NCT03594175 Feb 2020 → Jun 2023 thrombotic disease, vascular occlusion disorder Chiesi Farmaceutici S.p.A. Terminated No outcome recorded
Phase 3 NCT00046228 Aug 2002 → Jan 2008 myocardial infarction Centocor, Inc. Completed No outcome recorded
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
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 4 NCT00806403 Comparator Nov 2001 → Jun 2003 acute myocardial infarction Sahlgrenska University Hospital Completed No outcome recorded

Evidence & citations 13 cited values

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

FieldValueCited 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 2007
15

“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

ReteplaseNCT03594175

NCT00806403

NCT00046228

NCT00178620

NCT05900674

NCT00039832

NCT04571580

Known as BM 06.022 ChEMBL registry synonym — accepted as the source's own label CHEMBL2107885
Known as CUSA-081 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03992443
1

NCT03594175

Known as Ecokinase ChEMBL registry synonym — accepted as the source's own label CHEMBL2107885
Known as Rapilysin ChEMBL registry synonym — accepted as the source's own label CHEMBL2107885
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 Reteplasa ChEMBL registry synonym — accepted as the source's own label CHEMBL2107885
Known as Reteplase, recombinant ChEMBL registry synonym — accepted as the source's own label CHEMBL2107885
Known as Retevase ChEMBL registry synonym — accepted as the source's own label CHEMBL2107885
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 “CUSA-081 (reteplase) is a recombinant tissue plasminogen activator (tPA)” NCT03594175
Route Intravenous “Retavase is administered in a single dose through a needle in the vein over 2 minutes.” NCT00039832
Target PLAT “Tissue-type plasminogen activator exogenous protein” CHEMBL2107885