Last update 20 Mar 2025

Reteplase

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Reteplase (USAN/INN)
+ [5]
Target
Action
stimulants
Mechanism
PLG stimulants(Plasminogen stimulants)
Therapeutic Areas
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (29 Aug 1996),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D05721Reteplase

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acute myocardial infarction
European Union
29 Aug 1996
Acute myocardial infarction
Iceland
29 Aug 1996
Acute myocardial infarction
Norway
29 Aug 1996
Acute myocardial infarction
Liechtenstein
29 Aug 1996
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Catheter related thrombosisPreclinical
Romania
12 Feb 2020
Catheter related thrombosisPreclinical
Czechia
12 Feb 2020
Catheter related thrombosisPreclinical
Argentina
12 Feb 2020
Catheter related thrombosisPreclinical
United States
12 Feb 2020
Catheter related thrombosisPreclinical
Spain
12 Feb 2020
Catheter related thrombosisPreclinical
Belgium
12 Feb 2020
Catheter related thrombosisPreclinical
Poland
12 Feb 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
462
(CUSA-081)
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-
23 Aug 2024
Placebo
(Placebo)
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Phase 4
205
(Thrombolysis)
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-
10 Dec 2008
primary PCI
(Invasive)
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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