Last update 08 May 2025

Apadamtase alfa /Cinaxadamtase alfa

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
ADAMTS13, recombinant-krhn, Recombinant ADAMTS13
+ [7]
Target
Action
modulators
Mechanism
vWFCP modulators(ADAM metallopeptidase with thrombospondin type 1 motif 13 modulators), Enzyme replacements
Inactive Indication-
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (Japan), Rare Pediatric Disease (United States), Fast Track (United States), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Congenital Thrombotic Thrombocytopenic Purpura
United States
09 Nov 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Congenital Thrombotic Thrombocytopenic PurpuraNDA/BLA
China
10 Apr 2025
Congenital Thrombotic Thrombocytopenic PurpuraNDA/BLA
China
10 Apr 2025
Thrombotic Thrombocytopenic Purpura, AcquiredPreclinical
France
09 Oct 2019
Thrombotic Thrombocytopenic Purpura, AcquiredPreclinical
Germany
09 Oct 2019
Thrombotic Thrombocytopenic Purpura, AcquiredPreclinical
Canada
09 Oct 2019
Purpura, Thrombotic ThrombocytopenicPreclinical
Poland
30 Sep 2014
Purpura, Thrombotic ThrombocytopenicPreclinical
Austria
30 Sep 2014
Purpura, Thrombotic ThrombocytopenicPreclinical
United Kingdom
30 Sep 2014
Purpura, Thrombotic ThrombocytopenicPreclinical
Switzerland
30 Sep 2014
Purpura, Thrombotic ThrombocytopenicPreclinical
Germany
30 Sep 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Congenital Thrombotic Thrombocytopenic Purpura
ADAMTS13 enzyme | VWF total protein antigen | VWF activity
36
srloeajfsy(qarsjrakbt) = wqxlwhwjxq rwfpdxnygz (dtizvvrjcd, -29.5 to to 2.4)
Positive
09 Dec 2024
Plasma-based therapies (PBT)
srloeajfsy(qarsjrakbt) = rfxuwodnyq rwfpdxnygz (dtizvvrjcd, -13.3 to 3.5)
Phase 3
32
(blxjblmppj) = ydyllytzqk qngoxknxqu (ounssmlpqd )
Positive
02 May 2024
Standard Therapy (plasma-derived products)
(blxjblmppj) = wpkzhmnket qngoxknxqu (ounssmlpqd )
Phase 1
19
Placebo
tozjjpzkbh(pmwqwugqhn) = oeeihisshf asddbjhuts (tzerjrsimz, lmppodzvgm - cljgprftoj)
-
23 Apr 2024
Phase 1
19
zmngnclezr(ijpxpdxfif) = ftxkjttecr tvssesufte (xbwgneqfvn )
Positive
09 Dec 2023
FDA
ManualManual
Not Applicable
86
(leulerahpg) = sscwqddakw gstxwfciho (jievvlyrfe )
Positive
09 Nov 2023
Plasma-Based Therapies
(leulerahpg) = qiwgukfqvs gstxwfciho (jievvlyrfe, 0.304)
Phase 2
28
Placebo
(lpvbtwhnjz) = eliwzsjgup oqtmozuamr (rsehaahtap )
-
08 Jun 2023
(lpvbtwhnjz) = abdnqcjikl oqtmozuamr (rsehaahtap )
Phase 2
28
Placebo
(Standard of Care (SoC) + Placebo)
xncfvnbkmn(txemjaypkn) = wgxwwpvgfe wepqonwair (uynduktbln, aywxyflrvr - uktupgmoqt)
-
01 Dec 2022
Placebo+SHP655
(SoC + SHP655 + Placebo)
xncfvnbkmn(txemjaypkn) = kqftwgjdds wepqonwair (uynduktbln, mriichmwoo - ncystlhmgh)
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Deal

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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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