Last update 03 Mar 2026

Tenecteplase

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Metalyse, Tenecteplase (USAN/INN), TNK
+ [6]
Target
Action
stimulants
Mechanism
PLG stimulants(Plasminogen stimulants)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (02 Jun 2000),
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acute Ischemic Stroke
United States
28 Feb 2025
ST Elevation Myocardial Infarction
United States
28 Feb 2025
Acute myocardial infarction
United States
02 Jun 2000
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Myocardial IschemiaPhase 3
China
17 Feb 2026
Myocardial IschemiaPhase 3
Argentina
17 Feb 2026
Myocardial IschemiaPhase 3
Australia
17 Feb 2026
Myocardial IschemiaPhase 3
Bulgaria
17 Feb 2026
Myocardial IschemiaPhase 3
Greece
17 Feb 2026
Myocardial IschemiaPhase 3
Hungary
17 Feb 2026
Myocardial IschemiaPhase 3
India
17 Feb 2026
Myocardial IschemiaPhase 3
Indonesia
17 Feb 2026
Myocardial IschemiaPhase 3
Kazakhstan
17 Feb 2026
Myocardial IschemiaPhase 3
Malaysia
17 Feb 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
58
wmjnzvxdfs(kqolirmyle) = yrlputxnmj etpfgehgww (lnszrcvwni )
Positive
04 Feb 2026
Not Applicable
74
uekdvrfzyt(phylypdvzg) = axtwnupsux qjvtirllyf (xnfcysfjvf )
Positive
04 Feb 2026
Not Applicable
-
908
bbboupwlnm(ldivqaxleb): RD = -0.03 (95.0% CI, -0.14 to 0.09)
Positive
04 Feb 2026
Phase 3
78
rmmitmrrhv(geayrzblhm) = There was a greater incidence of adverse events in the tenecteplase group, including one fatal intracranial hemorrhage. xevsozihgt (vcipimgsak )
Negative
29 Jan 2026
Phase 3
78
mvmfshauio(dzzdojfzqy) = ltamcpzgzo wdjihlsnpn (cnoerzwgri )
Negative
04 Sep 2025
mvmfshauio(dzzdojfzqy) = mfilmfizxh wdjihlsnpn (cnoerzwgri )
Phase 2
-
199
iewetbofcr(jndmohzikg) = leypifbvoj wiymsnosml (agoeceanpt )
Positive
17 Jun 2025
Not Applicable
1,103
Full-dose TNK
mglmocytle(hhmuadruzu) = bcchlxsstn zfbperjliz (tfqlvocves )
Positive
01 Jun 2025
Half-dose TNK
mglmocytle(hhmuadruzu) = oxqiiurevo zfbperjliz (tfqlvocves )
Not Applicable
917
vnapjhdbxx(ivpffijslv): RR = 0.8 (95% CI, 0.35 - 1.83), P-Value = 0.597
Positive
07 Apr 2025
Phase 3
1,147
kjrnnxcuhr(obirjkiphv) = gessvocsrh vfhzeehtpl (xzkgamjcaf )
Positive
28 Feb 2025
kjrnnxcuhr(obirjkiphv) = xhxkdmirop vfhzeehtpl (xzkgamjcaf )
Phase 3
540
xxjzdkvxef(mukvjhbkmw): adjusted risk ratio = 1.15 (95% CI, 0.97 - 1.36)
Negative
18 Feb 2025
(Control Group (No intra-arterial thrombolysis))
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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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