Last update 22 Dec 2024

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
Mechanism
fibrin modulators(Fibrin modulators), Blood coagulation pathway activation
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (JP), Orphan Drug (US)
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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
EU
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
NO
03 Sep 2012
Hemorrhage
EU
03 Sep 2012
Hemorrhage
IS
03 Sep 2012
Hemorrhage
LI
03 Sep 2012
Hemorrhage
NO
03 Sep 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Colitis, UlcerativePhase 2
BG
01 Oct 2012
Colitis, UlcerativePhase 2
HR
01 Oct 2012
Colitis, UlcerativePhase 2
DK
01 Oct 2012
Colitis, UlcerativePhase 2
HU
01 Oct 2012
Colitis, UlcerativePhase 2
PL
01 Oct 2012
Colitis, UlcerativePhase 2
RU
01 Oct 2012
Colitis, UlcerativePhase 2
UA
01 Oct 2012
InflammationPhase 2
BG
01 Oct 2012
InflammationPhase 2
HR
01 Oct 2012
InflammationPhase 2
DK
01 Oct 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
30
urfrtgpqzr(vrjpcmpmzl) = All 10 SAEs were unlikely related to rFXIII-A2 nsnjkyyyhs (dpjlbpmcht )
Positive
27 Feb 2022
Not Applicable
20
ytoswwjhyv(bqcwbipwlc) = zpbafwjici btesguggkp (izangfwzkq )
Positive
17 Jul 2021
Not Applicable
17
nbvpwowjgu(tisylzvznf) = The efficacy and safety of rFXIII, used in most cases at the recommended dosage and frequency, was proven in all treated patients klunxusara (qlgxvtdesy )
-
12 Jul 2020
Phase 4
-
wdxyjgkgsf(bjgpnqzwdj) = nmcpcngelr dvtxgaeitf (bvftqbgxrd )
-
12 Jul 2020
Phase 3
60
lbrhrnnbqp(lbdhsduvxf) = without any safety concerns vqlvpywkrx (jatupenzvb )
Positive
01 Mar 2018
Phase 3
6
qbrztiglap(pnpayvpgnc) = Two serious adverse events, unrelated to rFXIII, were reported in a single child, each related to head injury, and neither resulting in intracranial hemorrhage. yhgcmlhcia (waafuoqdck )
Positive
01 Aug 2017
Phase 3
63
Recombinant Factor XIII (rFXIII)
(Recombinant Factor XIII (rFXIII))
xkgrzwkiny(yoasolzlqu) = iprtgxqdnc vvbuznnjsa (jnqcifflxo, bqsuucapgf - qvslpzrpck)
-
13 Dec 2016
rFXIII Novo Nordisk+rFXIII
(rFXIII Novo Nordisk)
pvcnucjktc(tefjmcqubr) = jfbdxmhkvo ndullqvixj (xjkjdwclen, lolntcxwtr - fcvewbvauq)
Phase 3
6
cnwkdqpnqp(mbmhquejog) = zwcviamxyr lcvmcseyjm (gqczsmwarn, ejgbyzqjgg - yyfopnzump)
-
24 Jun 2016
Phase 2
479
placebo
(Placebo)
xmfdebpnia(clzusgfbmv) = xjzpgrtbcv pxilfwlphf (lccfcjnpck, cioegfthmd - ztempwmbzf)
-
13 Nov 2014
(FXIII17.5IU/Kg)
xmfdebpnia(clzusgfbmv) = fzxogrqksb pxilfwlphf (lccfcjnpck, nozhjfgglb - xgcrryjmxi)
Phase 2
20
(rFXIII)
qyrkbtgjzj(wxipdveesy) = atcoibhbuu zwnqvsinxr (ppxerufqek, ezglwzrwpv - xauxjytuyt)
-
05 Aug 2014
placebo
(Placebo)
qyrkbtgjzj(wxipdveesy) = gzpiyvdjpu zwnqvsinxr (ppxerufqek, hqafnlbewi - aeqygawkqi)
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