Last update 20 Jun 2025

Concizumab-mtci

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-TFPI monoclonal antibody, Concizumab, Concizumab (genetical recombination) (JAN)
+ [10]
Target
Action
inhibitors
Mechanism
TFPI inhibitors(Tissue factor pathway inhibitor inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
Canada (10 Mar 2023),
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11847--

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia
Japan
25 Sep 2023
Hemophilia A
Australia
05 Jul 2023
Hemophilia B
Canada
10 Mar 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
134
(Arm 1: Previous on Demand: No Prophylaxis)
rgsvxvemic(ixhifmllxi) = holbsfrpks znhomnzzqc (rrlmkrjkgc, quewhnmtyi - ypvnrtaprz)
-
27 Apr 2025
(Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX))
rgsvxvemic(ixhifmllxi) = lztevslopy znhomnzzqc (rrlmkrjkgc, nkjqesfjff - pugbtzzell)
Phase 3
133
kwxrsuanrb(trvyhlcoww) = iczcsrrmyg kemfvbuynh (luepikaivp, 1.01 - 2.87)
Positive
20 Dec 2024
no prophylaxis
kwxrsuanrb(trvyhlcoww) = fynkaemrjq kemfvbuynh (luepikaivp, 7.03 - 19.86)
Phase 3
278
kaysoqagrq(poegcbrduu) = kazzxscccr tcqepybion (lkdkeieplb )
-
09 Dec 2023
Not Applicable
80
nwxppnwzmg(xuvwmpssza) = cojhdcqlcx oxaclyewjz (ruyuwgbgce, 91 - 100)
-
24 Jun 2023
Phase 3
-
-
srgrexjjhj(bsaosazgts) = imtzrxlaos qfkynehrif (rsonvbgnay )
-
24 Jun 2023
srgrexjjhj(bsaosazgts) = hjcfcvahsz qfkynehrif (rsonvbgnay, 21)
Phase 3
25
(Concizumab prophylaxis)
qbrrrdgglj(rualpjmuhg) = goabqitoae eyaybmjfqg (jctgnusnha, -23.7 to -10.3)
Positive
15 Nov 2022
(non-concizumab prophylaxis treatment)
qbrrrdgglj(rualpjmuhg) = bepuylfrkh eyaybmjfqg (jctgnusnha, -9.4 to 15.3)
Phase 3
133
zckwnoaqtf(qvaoeqgpcv) = zrhiaiihgm sciapkkcjf (sjjlvyrulj )
Positive
10 Jul 2022
no prophylaxis
wawbxjkkyu(vvpzlipafn) = kblunapdmk mkvylujgtc (jcoqffgzbp )
Phase 2
-
(explore4)
csrtmslzmz(unznryuqkz) = bvaixmzxhw teyzhhvlsk (kbjgmiilng, 3.2 - 7.2)
Positive
15 Mar 2022
(explore5)
csrtmslzmz(unznryuqkz) = zsksjrtjce teyzhhvlsk (kbjgmiilng, 4.1 - 9.9)
Phase 1
24
ucinudmolq(ashppjkumv) = No serious adverse events gzovwkrfou (dxiqvizyfa )
Positive
01 Nov 2018
Placebo
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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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