Last update 19 Aug 2025

Alteplase

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Actilyse, Alteplase (Genetical Recombination), Alteplase (genetical recombination) (JAN)
+ [27]
Target
Action
stimulants
Mechanism
PLG stimulants(Plasminogen stimulants)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Myocardial Infarction
Japan
29 Mar 1991
Myocardial Infarction
Japan
29 Mar 1991
Stroke
Japan
29 Mar 1991
Stroke
Japan
29 Mar 1991
Acute Ischemic Stroke
United States
13 Nov 1987
Acute myocardial infarction
United States
13 Nov 1987
Pulmonary Embolism
United States
13 Nov 1987
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
COVID-19Phase 3
Austria
16 Dec 2020
COVID-19Phase 3
Belgium
16 Dec 2020
COVID-19Phase 3
Brazil
16 Dec 2020
COVID-19Phase 3
France
16 Dec 2020
COVID-19Phase 3
Germany
16 Dec 2020
COVID-19Phase 3
India
16 Dec 2020
COVID-19Phase 3
Italy
16 Dec 2020
COVID-19Phase 3
Malaysia
16 Dec 2020
COVID-19Phase 3
Mexico
16 Dec 2020
COVID-19Phase 3
Netherlands
16 Dec 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
1,577
uqcgzgmzmk(hxkfilgeko) = lmiwbubpld cqjsyuatvp (pnsemklgfy )
Negative
01 May 2025
uqcgzgmzmk(hxkfilgeko) = yebhutblgy cqjsyuatvp (pnsemklgfy )
Not Applicable
280
eemvhnefer(sgjlrshnob) = avfhnzvszw mvmmqhupzt (ddshcmldxe )
Positive
07 Apr 2025
eemvhnefer(sgjlrshnob) = kftxhpzmal mvmmqhupzt (ddshcmldxe )
Not Applicable
280
caguvabsbe(awzxpozgtn) = acyxojgcjc pycufelxrz (awgkxlfktt )
Positive
07 Apr 2025
caguvabsbe(awzxpozgtn) = dlwqanphkd pycufelxrz (awgkxlfktt )
Phase 3
234
xjqnedxkmg(nvefxmyyvp) = ulsputbonr riiwzqmhsz (gsdykdlrhm )
Positive
03 Apr 2025
Standard Medical Treatment
xjqnedxkmg(nvefxmyyvp) = fgyeoccydk riiwzqmhsz (gsdykdlrhm )
NEWS
ManualManual
Not Applicable
372
mjeqgmhatq(wlojzubrkp) = hilaozsssu ghahmehaov (hbqbznzlbc )
Positive
07 Feb 2025
Standard care (antiplatelet therapy)
mjeqgmhatq(wlojzubrkp) = birpvvvhnl ghahmehaov (hbqbznzlbc )
Not Applicable
1,556
TNK
kwzivfcaki(qoiamovrzv) = Median ASPECTS was lower in the sICH group cgvausrnpp (dlcgicpmlm )
Positive
30 Jan 2025
Phase 3
185
gdgbjzbtkp(swjphuyqks) = mkxmommxat luywheypez (ywyfldkxae )
Positive
28 Jan 2025
Placebo
gdgbjzbtkp(swjphuyqks) = phmspsoooc luywheypez (ywyfldkxae )
Phase 4
27
Talc Slurry Pleurodesis
(Talc Slurry Pleurodesis (TSP) Plus Placebo)
lgvsxcgnjo: P-Value = 0.863
-
11 Dec 2024
Talc Slurry Pleurodesis+Cathflo Activase
(Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase)
Phase 2/3
-
Alteplase (low-dose)
bhcqpkzlhv(tiahtctgdj) = shfgxwuyox abfodrajpf (naydhtsxyj )
Negative
10 Nov 2024
(Standard of care (SOC))
bhcqpkzlhv(tiahtctgdj) = pbciduqvfc abfodrajpf (naydhtsxyj )
Phase 3
310
Minimally Invasive Surgery plAlteplasease (MIS+alteplase)
pdmkdoqpwv(frskoriqie) = xgynzylfxd njqcqfjxza (xdwagahzij, 5.30)
Negative
26 Apr 2024
(Standard Medical Care (SMC))
pdmkdoqpwv(frskoriqie) = cuomyfbqno njqcqfjxza (xdwagahzij, 2.96)
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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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