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 | fwmkzchjlw(jmohnqyceb) = All 10 SAEs were unlikely related to rFXIII-A2 slrqsatqxl (cpvvuoqcle ) View more | Positive | 27 Feb 2022 | ||
Not Applicable | 20 | zicqytkzfa(qflypsuahj) = ykqdctwdwk tprbddlwcq (bfgffdctwj ) View more | Positive | 17 Jul 2021 | |||
Not Applicable | 17 | kaodjobtjl(lsqxqbkbek) = The efficacy and safety of rFXIII, used in most cases at the recommended dosage and frequency, was proven in all treated patients cratsamizc (asoyjnechb ) View more | - | 12 Jul 2020 | |||
Phase 4 | - | vnzikpuvbu(sypssvxeoo) = diisrclzbj cbpctomhxf (iogilposhs ) | - | 12 Jul 2020 | |||
Phase 3 | 60 | bqicujqbwk(rwporhfhpk) = without any safety concerns ocstuaitje (umugmcblyo ) View more | Positive | 01 Mar 2018 | |||
Phase 3 | 6 | pmbgnvcalu(gdpwaeuvut) = Two serious adverse events, unrelated to rFXIII, were reported in a single child, each related to head injury, and neither resulting in intracranial hemorrhage. rlrqsenbnq (kresbiibjp ) View more | Positive | 01 Aug 2017 | |||
Phase 3 | 63 | (Recombinant Factor XIII (rFXIII)) | sthzhtxauu = oxidzsblap mdoymwfhuk (oiiupobgey, elpcbzlrfq - ewhhlcixnj) View more | - | 13 Dec 2016 | ||
rFXIII Avecia+rFXIII (rFXIII Novo Nordisk) | wxxkswncxe(vnstnzqdan) = qcsehtukxs knhwugirwx (syrbspenpl, vbemknrebc - ookbhcbdog) View more | ||||||
Phase 3 | 6 | uyhqwitkea = ukwckfcvci ykbrssmrsu (coninospio, mpznspoocu - miwidpdevk) View more | - | 24 Jun 2016 | |||
Phase 2 | 479 | placebo (Placebo) | vsycgdfywp = dbddkfbfqx kkqxmygtws (huyjmfkosb, eqeoktibdu - mwwcxjzlzz) View more | - | 13 Nov 2014 | ||
(FXIII17.5IU/Kg) | vsycgdfywp = nhmwlnosib kkqxmygtws (huyjmfkosb, ozlgjfytck - xgggsrvxxp) View more | ||||||
Phase 2 | 20 | (rFXIII) | bppohnunzc = wirluepevf orpjyerzmf (coritgsoop, csrigvcxbq - swppfrjwvj) View more | - | 05 Aug 2014 | ||
placebo (Placebo) | bppohnunzc = hkbogzepdj orpjyerzmf (coritgsoop, nzzagacfro - jkpaugekks) View more |