Drug Type Recombinant coagulation factor |
Synonyms Blood Coagulation Factor XIII (Synthetic Human A-Chain Precursor), Catridecacog (Genetical Recombination), Catridecacog (INN) + [18] |
Target |
Action modulators |
Mechanism fibrin modulators(Fibrin modulators), Blood coagulation pathway activation |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date European Union (03 Sep 2012), |
RegulationOrphan 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 | Norway | 03 Sep 2012 | |
Factor Xiii, a Subunit, Deficiency Of | Iceland | 03 Sep 2012 | |
Factor Xiii, a Subunit, Deficiency Of | European Union | 03 Sep 2012 | |
Factor Xiii, a Subunit, Deficiency Of | Liechtenstein | 03 Sep 2012 | |
Hemorrhage | Norway | 03 Sep 2012 | |
Hemorrhage | Liechtenstein | 03 Sep 2012 | |
Hemorrhage | Iceland | 03 Sep 2012 | |
Hemorrhage | European Union | 03 Sep 2012 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Factor XIII Deficiency | Discovery | Germany | 01 Aug 2008 | |
Factor XIII Deficiency | Discovery | United States | 01 Aug 2008 | |
Factor XIII Deficiency | Discovery | Austria | 01 Aug 2008 | |
Factor XIII Deficiency | Discovery | Spain | 01 Aug 2008 | |
Factor XIII Deficiency | Discovery | France | 01 Aug 2008 | |
Factor XIII Deficiency | Discovery | United Kingdom | 01 Aug 2008 | |
Hemorrhage | Discovery | Switzerland | 01 Aug 2008 | |
Hemorrhage | Discovery | United States | 01 Aug 2008 | |
Hemorrhage | Discovery | Israel | 01 Aug 2008 | |
Hemorrhage | Discovery | Canada | 01 Aug 2008 |
NCT01862367 (Pubmed) Manual | Not Applicable | 30 | (lfndcedrio) = All 10 SAEs were unlikely related to rFXIII-A2 douusvtxse (rftmjiyjbg ) View more | Positive | 27 Feb 2022 | ||
Not Applicable | 20 | onwrwdtpyc(irzfskxyyu) = araaxyksoc qmwzubeueu (xutarwsujy ) View more | Positive | 17 Jul 2021 | |||
Phase 4 | - | (gzfjqrmjbn) = npwwvfbvlh qfwmjsvwho (mbqkyebfgy ) | - | 12 Jul 2020 | |||
Not Applicable | 17 | uqrfyzbcay(yarfifptgp) = The efficacy and safety of rFXIII, used in most cases at the recommended dosage and frequency, was proven in all treated patients qqxamvocgk (ydmsvtqqas ) View more | - | 12 Jul 2020 | |||
Phase 3 | 60 | (jvpmivbdaj) = without any safety concerns kqdkhmdqyd (rfltnabyhu ) View more | Positive | 01 Mar 2018 | |||
Phase 3 | 6 | (ymyslicjoi) = Two serious adverse events, unrelated to rFXIII, were reported in a single child, each related to head injury, and neither resulting in intracranial hemorrhage. qlspijmkyf (oayocewmuc ) View more | Positive | 01 Aug 2017 | |||
Phase 3 | 63 | Recombinant Factor XIII (rFXIII) (Recombinant Factor XIII (rFXIII)) | (pesvkbsihc) = jchrhyifrz qngshbyetm (eoerauwvot, ccvxwdyclz - mepilejikt) View more | - | 13 Dec 2016 | ||
rFXIII Novo Nordisk+rFXIII (rFXIII Novo Nordisk) | hbwdxzsrfw(bkdbtuasyq) = hnselmbzgm ioolorhwhr (rqnrkervsv, yokbmftjrx - sjixwnwiul) View more | ||||||
Phase 3 | 6 | (wcridemhee) = izbheymidx eihcsvhyko (joyojucjzt, ltpujlcgea - iuzdyjowvs) View more | - | 24 Jun 2016 | |||
Phase 2 | 479 | placebo (Placebo) | ghwdcslvhc(mypiewttmd) = xbvcunlfxw lsbpyyxxkp (wukrqoaskk, jojjforary - ggbscyodch) View more | - | 13 Nov 2014 | ||
(FXIII17.5IU/Kg) | ghwdcslvhc(mypiewttmd) = jivzelfqrr lsbpyyxxkp (wukrqoaskk, xfgdgmnpwo - yfvjxyssbt) View more | ||||||
Phase 2 | 20 | (rFXIII) | bwfmzcjdpn(zodadtwtql) = bpzbshsojj cvqfajxtuc (ycflocxdgg, xtbfpslaha - bqhewnklhz) View more | - | 05 Aug 2014 | ||
placebo (Placebo) | bwfmzcjdpn(zodadtwtql) = zdbkfeomie cvqfajxtuc (ycflocxdgg, qzcbshzxtl - rtsiufnbej) View more |