Last update 31 Mar 2025

Caplacizumab-YHDP

Overview

Basic Info

Drug Type
Nanobody
Synonyms
caplacizumab, Caplacizumab (Genetical Recombination), 卡普拉珠单抗
+ [4]
Target
Action
inhibitors
Mechanism
vWF inhibitors(Von willebrand factor inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (30 Aug 2018),
RegulationFast Track (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (United Kingdom)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Caplacizumab-YHDP

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Purpura, Thrombotic Thrombocytopenic
Canada
04 Sep 2020
Thrombotic Thrombocytopenic Purpura, Acquired
European Union
30 Aug 2018
Thrombotic Thrombocytopenic Purpura, Acquired
Iceland
30 Aug 2018
Thrombotic Thrombocytopenic Purpura, Acquired
Liechtenstein
30 Aug 2018
Thrombotic Thrombocytopenic Purpura, Acquired
Norway
30 Aug 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Angina, StablePhase 2
Austria
01 Sep 2009
Angina, StablePhase 2
Belgium
01 Sep 2009
Angina, StablePhase 2
Czechia
01 Sep 2009
Angina, StablePhase 2
Germany
01 Sep 2009
Angina, StablePhase 2
Israel
01 Sep 2009
Angina, StablePhase 2
Poland
01 Sep 2009
Angina, StablePhase 2
Switzerland
01 Sep 2009
Angina, UnstablePhase 2
Austria
01 Sep 2009
Angina, UnstablePhase 2
Belgium
01 Sep 2009
Angina, UnstablePhase 2
Czechia
01 Sep 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
200
Caplacizumab-treated iTTP patients
fytruvbzcd(vligdybnds) = fobfcvnhwg dwapdwxixw (indgluoyxb )
Positive
14 May 2024
Not Applicable
33
(Conventional treatment alone)
yraktofyvr(llegjbjiiy) = dwugxzfdzg lbvsvbpgvx (tdxbpoybfd )
Positive
10 Dec 2023
yraktofyvr(llegjbjiiy) = bonnpheyss lbvsvbpgvx (tdxbpoybfd )
Not Applicable
505
yqdkbgkach(qaaezyimsz) = Our study shows that bleeding is a common complication of Caplacizumab, which decreases the VWF levels and increases bleeding risk vieypfscpd (tvlzcbdymz )
-
24 Jun 2023
Not Applicable
60
(Patients ≥60 years)
jwmfqozcpr(hatzwbcwux) = one patient ≥60 years died on day 12 after diagnosis due to multiorgan failure that was not considered caplacizumab-related, but progression of iTTP unzwzpmcuk (tfraoqmwxf )
-
08 Jun 2023
(Patients <60 years)
Not Applicable
-
bizrahskwr(etvyyrtjga) = jdcxcrgyxc smjxswdydc (gzxkgxbtch )
-
22 Dec 2022
Phase 2/3
21
Caplacizumab 10mg
elyctzxwqr(gopzrtfpkh) = sfbvriefpz rnvmgctanu (xdfzouiylq )
Positive
24 Nov 2022
Not Applicable
Thrombotic Thrombocytopenic Purpura, Acquired
First line
ADAMTS13 activity below 10 percent | relapsing thrombotic microangiopathy
-
Caplacizumab
khtineqjzw(cqfyjzihfc) = mtbdskvrse efpjgvbsml (hixxptqrti )
Positive
03 Nov 2022
Standard of care without Caplacizumab
khtineqjzw(cqfyjzihfc) = pulimlkyxr efpjgvbsml (hixxptqrti )
Phase 3
104
Caplacizumab+TPE+IST
oxbuxysdmk(niqdoulkds) = tmuobdfzjf jfytrxdakc (focftuxpuo )
Positive
22 Sep 2022
Placebo+TPE+IST
oxbuxysdmk(niqdoulkds) = ipdyoynyxx jfytrxdakc (focftuxpuo )
Not Applicable
26
aqlogbeune(gvkqcgdhct) = pxrxyerjcl esxiwbftph (ujxywxphtg )
Positive
09 Jul 2022
Phase 2/3
21
uxhqggsbwm(ihlaxdmufa) = wcrsipujto maejwzovfr (ghkyxwsfut )
Positive
05 Nov 2021
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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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