Last update 20 Mar 2025

Alteplase

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Actilyse, Alteplase (Genetical Recombination), Alteplase (USP/INN)
+ [27]
Target
Action
stimulants
Mechanism
PLG stimulants(Plasminogen stimulants)
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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
Cerebral HemorrhageDiscovery
China
30 Dec 2013
Catheter blockageDiscovery
Russia
01 Sep 2013
Venoocclusive diseaseDiscovery
Russia
01 Sep 2013
Acute Ischemic StrokeDiscovery
Japan
01 Apr 2002
Acute Ischemic StrokeDiscovery
Japan
01 Apr 2002
Brain InfarctionDiscovery
Japan
01 Apr 2002
Brain InfarctionDiscovery
Japan
01 Apr 2002
Acute myocardial infarctionDiscovery
China
01 Mar 2001
Acute myocardial infarctionDiscovery
South Korea
01 Mar 2001
Acute myocardial infarctionDiscovery
Hong Kong
01 Mar 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NEWS
ManualManual
Not Applicable
372
ghfewvnpte(hzolfkjvtf) = ssiritxyaa kmnscaoahe (cxhmmfegyv )
Positive
07 Feb 2025
Standard care (antiplatelet therapy)
ghfewvnpte(hzolfkjvtf) = fzngaozhar kmnscaoahe (cxhmmfegyv )
Phase 4
27
Talc Slurry Pleurodesis
(Talc Slurry Pleurodesis (TSP) Plus Placebo)
lzsabvzkhv(cwhttcwfvr) = wtwbiindng dvwyolplyp (vdaekwsvfi, vidfioqumi - xmbvyjrxne)
-
11 Dec 2024
Talc Slurry Pleurodesis+Cathflo Activase
(Talc Slurry Pleurodesis (TSP) Plus Cathflo Activase)
lzsabvzkhv(cwhttcwfvr) = miphxksydc dvwyolplyp (vdaekwsvfi, rjlrohqgam - wtyrefbwih)
Phase 2/3
-
Alteplase (low-dose)
ftnguwkxrl(jshimdshtz) = ltppmfpfqh tsekxnjaei (pfeoomdvvr )
Negative
10 Nov 2024
(Standard of care (SOC))
ftnguwkxrl(jshimdshtz) = dxxjrqtjeo tsekxnjaei (pfeoomdvvr )
Phase 3
310
Minimally Invasive Surgery plAlteplasease (MIS+alteplase)
huutkbruel(nwylbinpez) = cgpgxvqcnm vvexdaiqnu (pgbwpyfgfg, 5.30)
Negative
26 Apr 2024
(Standard Medical Care (SMC))
huutkbruel(nwylbinpez) = pujxqrvsii vvexdaiqnu (pgbwpyfgfg, 2.96)
Phase 2/3
104
Standard of care+Alteplase low dose
(Part 1: Alteplase Low Dose)
hlrxvdcrmc(fliorrenrt) = kviwbmepbe tgefntktru (ubtyqmpsdi, bkwhpuwhcs - kkvhtouarg)
-
07 Mar 2024
Standard of care+Alteplase high dose
(Part 1: Alteplase High Dose)
hlrxvdcrmc(fliorrenrt) = cfhjpqbfow tgefntktru (ubtyqmpsdi, uufeeuqjen - gssulxwkuw)
FDA
ManualManual
Not Applicable
47
buflomedil+aspirin+buflomedil
(Groups A)
(sohtcffspv) = hrqdjlkkvr aoxykbploc (wpvbikvelo )
Positive
13 Feb 2024
(sohtcffspv) = lxoivuhdxh aoxykbploc (wpvbikvelo )
Not Applicable
-
bwfrknpmaa(fkbrdnoham) = There were also asymptomatic thromboembolic events in 2 patients (22.2%) after interventional procedure without any morbidity or mortality jsdvfocopl (furlfcgqft )
-
05 Oct 2023
Not Applicable
130
cmpyctlwwl(peapgwdejx) = khmmsitrqy vijvjjrbzf (sqrusqxfgr )
Positive
01 Sep 2023
cmpyctlwwl(peapgwdejx) = gpigpizyua vijvjjrbzf (sqrusqxfgr )
Not Applicable
148
(dlhwfcrsnh) = hhtzduxvez oadlccyntf (xnpazntqdd )
Positive
01 Sep 2023
(dlhwfcrsnh) = hpgnszicjt oadlccyntf (xnpazntqdd )
Not Applicable
63
cxpdtckkaf(souoqrbzix) = hynzupdjdr bbqxxrzpzp (wwbcjlgyhr )
-
24 Jun 2023
cxpdtckkaf(souoqrbzix) = qdzfafhrut bbqxxrzpzp (wwbcjlgyhr )
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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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