Last update 21 Nov 2024

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
Mechanism
fibrin modulators(Fibrin modulators), Blood coagulation pathway activation
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (JP)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Factor XIII Deficiency
CH
25 Oct 2012
Factor Xiii, a Subunit, Deficiency Of
NO
03 Sep 2012
Factor Xiii, a Subunit, Deficiency Of
IS
03 Sep 2012
Factor Xiii, a Subunit, Deficiency Of
LI
03 Sep 2012
Factor Xiii, a Subunit, Deficiency Of
EU
03 Sep 2012
Hemorrhage
IS
03 Sep 2012
Hemorrhage
NO
03 Sep 2012
Hemorrhage
LI
03 Sep 2012
Hemorrhage
EU
03 Sep 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Factor XIII DeficiencyPreclinical
GB
01 Aug 2008
HemorrhagePreclinical
US
01 Aug 2008
HemorrhagePreclinical
IL
01 Aug 2008
HemorrhagePreclinical
CH
01 Aug 2008
HemorrhagePreclinical
CA
01 Aug 2008
Factor XIII DeficiencyDiscovery
FR
01 Aug 2008
Factor XIII DeficiencyDiscovery
US
01 Aug 2008
Factor XIII DeficiencyDiscovery
FI
01 Aug 2008
Factor XIII DeficiencyDiscovery
ES
01 Aug 2008
Factor XIII DeficiencyDiscovery
IT
01 Aug 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
30
(gqmduepkee) = All 10 SAEs were unlikely related to rFXIII-A2 yyokjpqwiv (nxyviwhffx )
Positive
27 Feb 2022
Not Applicable
20
igvrkwgkke(uqqqxulqsj) = hetymfhrac mgoyivedci (vmpbiyfflc )
Positive
17 Jul 2021
Not Applicable
17
vkylgxeihf(rfaumgvcqk) = The efficacy and safety of rFXIII, used in most cases at the recommended dosage and frequency, was proven in all treated patients fwawhvgfkv (onpcttayqc )
-
12 Jul 2020
Phase 4
-
(jgijifzctf) = eurueqqloz yjxmxtljci (fntnbittsx )
-
12 Jul 2020
Phase 3
60
(gwxkucujge) = without any safety concerns svbdqnksov (wuzejjfdrx )
Positive
01 Mar 2018
Phase 3
6
(zkzmygxeti) = Two serious adverse events, unrelated to rFXIII, were reported in a single child, each related to head injury, and neither resulting in intracranial hemorrhage. otkseqfafr (zkqkjivggp )
Positive
01 Aug 2017
Phase 3
63
Recombinant Factor XIII (rFXIII)
(Recombinant Factor XIII (rFXIII))
(jnwuhdgvqd) = hwdqpmovgt cgulnwlchs (fcairwokok, qvneirbfkk - cdcsyjimco)
-
13 Dec 2016
rFXIII Novo Nordisk+rFXIII
(rFXIII Novo Nordisk)
zdpywijzah(fmtwfcbqfw) = eemtwkyxxi ykxzvdkztl (dnbmhmnchc, vtcegbyuft - wkfdlvmmse)
Phase 3
6
(pecgcywkod) = hzhxtbutnd gqhrbuzdzr (hfnoiwfajm, bwvvkymnic - otbeqnvogn)
-
24 Jun 2016
Phase 3
23
qkahbkthfv(mdjxvgfthb) = munlpmhcnh wqxhhtauts (fhhvyqrich )
-
01 Dec 2014
Phase 2
479
placebo
(Placebo)
pvjxpiixwt(rszekonhik) = etikdzeldh dsazeuyezk (ynfueqaxxc, xeospklsaw - cltuzqqmiw)
-
13 Nov 2014
(FXIII17.5IU/Kg)
pvjxpiixwt(rszekonhik) = wuiunuvkpl dsazeuyezk (ynfueqaxxc, epjormlybh - awxdszikuf)
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Regulation

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