Last update 20 Mar 2025

Catridecacog

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Blood Coagulation Factor XIII (Synthetic Human A-Chain Precursor), Catridecacog (Genetical Recombination), Catridecacog (INN)
+ [18]
Target
Action
modulators
Mechanism
fibrin modulators(Fibrin modulators), Blood coagulation pathway activation
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (Japan)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Factor XIII Deficiency
Switzerland
25 Oct 2012
Factor Xiii, a Subunit, Deficiency Of
Norway
03 Sep 2012
Factor Xiii, a Subunit, Deficiency Of
Iceland
03 Sep 2012
Factor Xiii, a Subunit, Deficiency Of
European Union
03 Sep 2012
Factor Xiii, a Subunit, Deficiency Of
Liechtenstein
03 Sep 2012
Hemorrhage
Norway
03 Sep 2012
Hemorrhage
Liechtenstein
03 Sep 2012
Hemorrhage
Iceland
03 Sep 2012
Hemorrhage
European Union
03 Sep 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Factor XIII DeficiencyDiscovery
Germany
01 Aug 2008
Factor XIII DeficiencyDiscovery
United States
01 Aug 2008
Factor XIII DeficiencyDiscovery
Austria
01 Aug 2008
Factor XIII DeficiencyDiscovery
Spain
01 Aug 2008
Factor XIII DeficiencyDiscovery
France
01 Aug 2008
Factor XIII DeficiencyDiscovery
United Kingdom
01 Aug 2008
HemorrhageDiscovery
Switzerland
01 Aug 2008
HemorrhageDiscovery
United States
01 Aug 2008
HemorrhageDiscovery
Israel
01 Aug 2008
HemorrhageDiscovery
Canada
01 Aug 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
30
(lfndcedrio) = All 10 SAEs were unlikely related to rFXIII-A2 douusvtxse (rftmjiyjbg )
Positive
27 Feb 2022
Not Applicable
20
onwrwdtpyc(irzfskxyyu) = araaxyksoc qmwzubeueu (xutarwsujy )
Positive
17 Jul 2021
Phase 4
-
(gzfjqrmjbn) = npwwvfbvlh qfwmjsvwho (mbqkyebfgy )
-
12 Jul 2020
Not Applicable
17
uqrfyzbcay(yarfifptgp) = The efficacy and safety of rFXIII, used in most cases at the recommended dosage and frequency, was proven in all treated patients qqxamvocgk (ydmsvtqqas )
-
12 Jul 2020
Phase 3
60
(jvpmivbdaj) = without any safety concerns kqdkhmdqyd (rfltnabyhu )
Positive
01 Mar 2018
Phase 3
6
(ymyslicjoi) = Two serious adverse events, unrelated to rFXIII, were reported in a single child, each related to head injury, and neither resulting in intracranial hemorrhage. qlspijmkyf (oayocewmuc )
Positive
01 Aug 2017
Phase 3
63
Recombinant Factor XIII (rFXIII)
(Recombinant Factor XIII (rFXIII))
(pesvkbsihc) = jchrhyifrz qngshbyetm (eoerauwvot, ccvxwdyclz - mepilejikt)
-
13 Dec 2016
rFXIII Novo Nordisk+rFXIII
(rFXIII Novo Nordisk)
hbwdxzsrfw(bkdbtuasyq) = hnselmbzgm ioolorhwhr (rqnrkervsv, yokbmftjrx - sjixwnwiul)
Phase 3
6
(wcridemhee) = izbheymidx eihcsvhyko (joyojucjzt, ltpujlcgea - iuzdyjowvs)
-
24 Jun 2016
Phase 2
479
placebo
(Placebo)
ghwdcslvhc(mypiewttmd) = xbvcunlfxw lsbpyyxxkp (wukrqoaskk, jojjforary - ggbscyodch)
-
13 Nov 2014
(FXIII17.5IU/Kg)
ghwdcslvhc(mypiewttmd) = jivzelfqrr lsbpyyxxkp (wukrqoaskk, xfgdgmnpwo - yfvjxyssbt)
Phase 2
20
(rFXIII)
bwfmzcjdpn(zodadtwtql) = bpzbshsojj cvqfajxtuc (ycflocxdgg, xtbfpslaha - bqhewnklhz)
-
05 Aug 2014
placebo
(Placebo)
bwfmzcjdpn(zodadtwtql) = zdbkfeomie cvqfajxtuc (ycflocxdgg, qzcbshzxtl - rtsiufnbej)
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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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