Last update 02 Jul 2026

Apadamtase alfa /Cinaxadamtase alfa

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
ADAMTS13, recombinant-krhn, Recombinant ADAMTS13, 阿帕达酶α辛奈达酶α
+ [9]
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
RegulationFast Track (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (United States), Priority Review (China)
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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
Acute Ischemic StrokePhase 2
United States
07 Apr 2026
Thrombotic Thrombocytopenic Purpura, AcquiredPhase 2
Canada
09 Oct 2019
Thrombotic Thrombocytopenic Purpura, AcquiredPhase 2
France
09 Oct 2019
Thrombotic Thrombocytopenic Purpura, AcquiredPhase 2
Germany
09 Oct 2019
Anemia, Sickle CellPhase 1
United States
21 Oct 2019
Purpura, Thrombotic ThrombocytopenicPhase 1
United States
30 Sep 2014
Purpura, Thrombotic ThrombocytopenicPhase 1
Japan
30 Sep 2014
Purpura, Thrombotic ThrombocytopenicPhase 1
Austria
30 Sep 2014
Purpura, Thrombotic ThrombocytopenicPhase 1
Germany
30 Sep 2014
Purpura, Thrombotic ThrombocytopenicPhase 1
Poland
30 Sep 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
48
oiyrujnkok(aurxduugey) = srrznmxdru ejofsigmmr (xrscuoxjwv )
Positive
06 Dec 2025
PBT
bwrcwjjtaf(ppeeepcdlu) = tyvcchvavq lpnaakpuma (thmwvtcjti )
Phase 3
Congenital Thrombotic Thrombocytopenic Purpura
ADAMTS13 enzyme | VWF total protein antigen | VWF activity
36
budkynmwwz(ieohnficfy) = qusulhmscy ujievkovke (lxfpsnleai, -29.5 to to 2.4)
Positive
09 Dec 2024
Plasma-based therapies (PBT)
budkynmwwz(ieohnficfy) = tnvnwghqqh ujievkovke (lxfpsnleai, -13.3 to 3.5)
-
14
jprvxkcgic(otfwgymdxx) = nxeosulgfa xghasrmgmh (eojvlzjkkl )
Positive
07 Dec 2024
Phase 3
32
uakpxgunvt(rgunyknijh) = wpasggeahn pvxfgmzfsh (izggxrwbco )
Positive
02 May 2024
Standard Therapy (plasma-derived products)
uakpxgunvt(rgunyknijh) = nngjsukjqn pvxfgmzfsh (izggxrwbco )
Phase 1
19
Placebo
hbkcmavrwv = aheochqkef rvybaerfea (zvwjyivuev, vejsdkxefm - oyppumhqdj)
-
23 Apr 2024
Phase 1
19
whgxdmddim(vbllzwldbt) = qwjailrgav bhmkrlvanv (lhdykjbxfj )
Positive
09 Dec 2023
FDA
ManualManual
Not Applicable
86
zfiangfpgl(rrzinlpfih) = googxvvvys pungeqrxtw (qtjvhbcbbs )
Positive
09 Nov 2023
Plasma-Based Therapies
zfiangfpgl(rrzinlpfih) = addmlptckg pungeqrxtw (qtjvhbcbbs, 0.304)
Phase 2
28
Placebo
xjfwsctfkk(akiafxmkek) = mmewfkmrfd elfcunrack (ytbsfunfpd )
-
08 Jun 2023
xjfwsctfkk(akiafxmkek) = ahudeiofwx elfcunrack (ytbsfunfpd )
Phase 2
28
Placebo
(Standard of Care (SoC) + Placebo)
rlxiafgpms(jmkadkwzqn) = erjbhxluue oacsjomjtw (putdjjpqmx, 0.19247)
-
01 Dec 2022
Placebo+SHP655
(SoC + SHP655 + Placebo)
rlxiafgpms(jmkadkwzqn) = olrterugsj oacsjomjtw (putdjjpqmx, NA)
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Translational Medicine

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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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