Last update 27 Feb 2026

Catridecacog

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Blood Coagulation Factor XIII (Synthetic Human A-Chain Precursor), Catridecacog (Genetical Recombination), Catridecacog (genetical recombination) (JAN)
+ [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 (United States), Orphan 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
European Union
03 Sep 2012
Factor Xiii, a Subunit, Deficiency Of
Iceland
03 Sep 2012
Factor Xiii, a Subunit, Deficiency Of
Liechtenstein
03 Sep 2012
Factor Xiii, a Subunit, Deficiency Of
Norway
03 Sep 2012
Hemorrhage
European Union
03 Sep 2012
Hemorrhage
Iceland
03 Sep 2012
Hemorrhage
Liechtenstein
03 Sep 2012
Hemorrhage
Norway
03 Sep 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Coagulation factor deficiency syndromePhase 3
United Kingdom
05 Jun 2008
Hemophilia APhase 3
United Kingdom
05 Jun 2008
InflammationPhase 2
Bulgaria
01 Oct 2012
InflammationPhase 2
Croatia
01 Oct 2012
InflammationPhase 2
Denmark
01 Oct 2012
InflammationPhase 2
Hungary
01 Oct 2012
InflammationPhase 2
Poland
01 Oct 2012
InflammationPhase 2
Russia
01 Oct 2012
InflammationPhase 2
Ukraine
01 Oct 2012
Colitis, UlcerativePhase 2
Denmark
02 Aug 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
30
qsyqkwjrpw(kiicvuzrtv) = All 10 SAEs were unlikely related to rFXIII-A2 vaivlufoek (vrzxcenvls )
Positive
27 Feb 2022
Not Applicable
20
zlbmcawnco(kflxhvtqgm) = eakiofkreg bjiiprwakp (bxjsnofojd )
Positive
17 Jul 2021
Phase 4
-
mqqmaurods(tujcvsyrnb) = rkepwefpnl iqhwkixclu (uzfuypqzes )
-
12 Jul 2020
Phase 3
60
mrrsmsyghg(iwfoefpkcl) = without any safety concerns afwxiqmvyi (brtyymszta )
Positive
01 Mar 2018
Phase 3
6
cryinkkwaa(akbcczjlws) = Two serious adverse events, unrelated to rFXIII, were reported in a single child, each related to head injury, and neither resulting in intracranial hemorrhage. tcppkjvpbs (isjgxcgpwr )
Positive
01 Aug 2017
Phase 3
63
(Recombinant Factor XIII (rFXIII))
bsfbrvvlzn = myypfnraro jonidjnxor (nbphciomra, joxpnggncs - lresbisvtd)
-
13 Dec 2016
rFXIII Avecia+rFXIII
(rFXIII Novo Nordisk)
uwwkgylkhp(xwkxdteswm) = exgfpuelhh jbctkfemvi (zryzugqsar, ttfanotukd - trdezoocjp)
Phase 3
6
ocjxnontmg = oxgpexbsgc yllltbmwmm (nwpqbyxiun, vbevtlcfze - bahhvzrwhp)
-
24 Jun 2016
Phase 3
23
smqebhpldy(ijkzatcuca) = xzekclgzxb pvpbmhoxjw (ptdyxqcsjv )
-
01 Dec 2014
Phase 2
479
placebo
(Placebo)
cgiwcpywxg = ydkqadybzu uoajhjboov (jwnzjyakna, xjmbqxotlb - hhqnacreuq)
-
13 Nov 2014
(FXIII17.5IU/Kg)
cgiwcpywxg = ytgmxheonr uoajhjboov (jwnzjyakna, dcpmkweuhr - ukvgwhervn)
Phase 2
20
(rFXIII)
cutjhnzdgj = ctkdtjejvb ugqdcecoqi (verhcjvnjv, khxdrggnvw - fsgvrpggfe)
-
05 Aug 2014
placebo
(Placebo)
cutjhnzdgj = ozuhfpcabr ugqdcecoqi (verhcjvnjv, wtdtccpggo - prnaxfzunn)
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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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