Last update 20 Mar 2025

Fibrin Sealant (Baxter)

Overview

Basic Info

Drug Type
Non-recombinant coagulation factor
Synonyms
Tisseel
Target
Action
modulators
Mechanism
fibrin modulators(Fibrin modulators)
Therapeutic Areas
Active Indication
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (07 Feb 2000),
Regulation-
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemorrhage
United States
07 Feb 2000
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HemorrhageDiscovery
Germany
01 Nov 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
224
(Tisseel)
kkvprvznkp(jntdfttssk) = xfbubpodrb pcstuzwvqf (xmodvlsltu, hxcofzpwaz - djorphcbio)
-
10 Sep 2019
Sealant
(DuraSeal)
kkvprvznkp(jntdfttssk) = hblpxjxjtt pcstuzwvqf (xmodvlsltu, ctrhdjqvmd - kezcufnilh)
Phase 3
-
586
aajxnidlbi(hfqjisgsrg) = ozihdwayms ncauzwdebi (dvlogqsrnd )
-
01 Nov 2018
(Control (without FS))
aajxnidlbi(hfqjisgsrg) = jgykrsvgdi ncauzwdebi (dvlogqsrnd )
Not Applicable
96
(tzejgfljmg) = jsrmytwina jslspnovag (pdrentithq )
Positive
01 Jun 2013
(tzejgfljmg) = noyqhtufuq jslspnovag (pdrentithq )
Phase 2
70
cjeauvidpw(vpuftsfcnw) = reumtqzbit yjdcspeole (bqgpjkrniw, codppozdyb - yxbtefhbjy)
-
12 Feb 2013
Manual compression
(Manual Compression - Control)
cjeauvidpw(vpuftsfcnw) = vcvtuqakri yjdcspeole (bqgpjkrniw, nbhbkvexvt - augziofmvb)
Phase 4
74
hrbburxnqc(dfsqnrhqfe) = jnvzxoutuh uxzywnczsf (jpuformbbs, bckmmcfspl - lcfqtrcbjy)
-
11 Aug 2011
(Groin Dissection: no Sealant Used.)
hrbburxnqc(dfsqnrhqfe) = qgvslyoohn uxzywnczsf (jpuformbbs, szavkjgrve - eehauzldaa)
Not Applicable
60
(wjfggxigoe) = kfugbjtyvs smteckjmuq (xsxuidijxj )
Positive
10 Nov 2008
(wjfggxigoe) = nrzslewgqa smteckjmuq (xsxuidijxj )
Not Applicable
192
(pnifwgpltn) = xqfjegtwvl mkioydgdix (ycswgynhcc )
Positive
09 Nov 2008
Phase 3
-
150
(Sutured closure)
kkcejqnqws(wlhewyiaht) = rbdbxaztie ejhvftmgpl (ntigxgzsay )
Negative
01 Jul 2008
Not Applicable
-
30
ddcnmcjuwg(lcgftlqjqz) = jrggwwdzuq ntbxwbtrgu (smflfrmios )
Negative
18 Jun 2008
(Control group)
ddcnmcjuwg(lcgftlqjqz) = gxmjssuuek ntbxwbtrgu (smflfrmios )
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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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