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 |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (03 Sep 2012), |
RegulationOrphan Drug (United States), Orphan Drug (Japan) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10532 | Catridecacog |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Colitis, Ulcerative | Phase 2 | Bulgaria | 01 Oct 2012 | |
Colitis, Ulcerative | Phase 2 | Croatia | 01 Oct 2012 | |
Colitis, Ulcerative | Phase 2 | Denmark | 01 Oct 2012 | |
Colitis, Ulcerative | Phase 2 | Hungary | 01 Oct 2012 | |
Colitis, Ulcerative | Phase 2 | Poland | 01 Oct 2012 | |
Colitis, Ulcerative | Phase 2 | Russia | 01 Oct 2012 | |
Colitis, Ulcerative | Phase 2 | Ukraine | 01 Oct 2012 | |
Inflammation | Phase 2 | Bulgaria | 01 Oct 2012 | |
Inflammation | Phase 2 | Croatia | 01 Oct 2012 | |
Inflammation | Phase 2 | Denmark | 01 Oct 2012 |
NCT01862367 (Pubmed) Manual | Not Applicable | 30 | wtknzrlpkd(mbsumorwmj) = All 10 SAEs were unlikely related to rFXIII-A2 dapolooxxw (zgaekjbddf ) View more | Positive | 27 Feb 2022 | ||
Not Applicable | 20 | ipvstztqxf(kzobocvmzj) = fvdimlafxt deiortuhph (hfxrukkcbp ) View more | Positive | 17 Jul 2021 | |||
Phase 4 | - | uinkfuzwji(puthlqrgrh) = wlwhxhaykc tsllddpomr (iiqvkvpebk ) | - | 12 Jul 2020 | |||
Not Applicable | 17 | lshizrjzcf(mlqunkkcqh) = The efficacy and safety of rFXIII, used in most cases at the recommended dosage and frequency, was proven in all treated patients asuooympgc (qodzghtxnf ) View more | - | 12 Jul 2020 | |||
Phase 3 | 60 | cspkdyuouq(tdktrrbome) = without any safety concerns tehswitodq (jzdpneujlq ) View more | Positive | 01 Mar 2018 | |||
Phase 3 | 6 | fbrqucezfr(wygdazbtvo) = Two serious adverse events, unrelated to rFXIII, were reported in a single child, each related to head injury, and neither resulting in intracranial hemorrhage. mpfxcppcse (yezieeweqq ) View more | Positive | 01 Aug 2017 | |||
Phase 3 | 63 | (Recombinant Factor XIII (rFXIII)) | xatokwjskd = ezonmgvaaw bksuoiwdxw (vomznqytqk, jzfxddjltn - qxbulivetx) View more | - | 13 Dec 2016 | ||
rFXIII Avecia+rFXIII (rFXIII Novo Nordisk) | bgvabixrcr(rarotaahzk) = njguqbqqrw oossofpbts (iizjkncxjr, ijihvpxbee - femzozxjdv) View more | ||||||
Phase 3 | 6 | kcxuzejnse = wgeullsrrt rrqazlztwm (hqyhvxuwva, dsifoyhwif - jrowvkadeb) View more | - | 24 Jun 2016 | |||
Phase 2 | 479 | placebo (Placebo) | wmdtbzbvrg = ahpjwqnboi nynkqkswko (wzkukcxfas, mplaqnetys - xcqboegbwz) View more | - | 13 Nov 2014 | ||
(FXIII17.5IU/Kg) | wmdtbzbvrg = wgvmxiotzl nynkqkswko (wzkukcxfas, kgjzabtfsm - bscwngbjqc) View more | ||||||
Phase 2 | 20 | (rFXIII) | mweiyknjox = thomyfwkpr qfkwqufpxs (jzkgnnipac, rhzyboncfg - zqesqcgixy) View more | - | 05 Aug 2014 | ||
placebo (Placebo) | mweiyknjox = vsyhitoqsz qfkwqufpxs (jzkgnnipac, omfqjizojn - hxulwchcwg) View more |