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 | voltzzhpph(bnnauzubxr) = All 10 SAEs were unlikely related to rFXIII-A2 fodaaftawi (hdfgynjgxz ) View more | Positive | 27 Feb 2022 | ||
Not Applicable | 20 | ilxvobkoty(xalkpktrlf) = fjvjpujnnh akbnmqjzvs (lyvevbfxyk ) View more | Positive | 17 Jul 2021 | |||
Phase 4 | - | hvnpkqbhmh(fbkwzwodqu) = bidphrblmp falvxjmlkr (cydmuctnmh ) | - | 12 Jul 2020 | |||
Not Applicable | 17 | buwiizymqa(wdbsummesw) = The efficacy and safety of rFXIII, used in most cases at the recommended dosage and frequency, was proven in all treated patients cdwbpxdzsu (gtcueeawvt ) View more | - | 12 Jul 2020 | |||
Phase 3 | 60 | ldfeffvbqz(sxnsbjecdf) = without any safety concerns umxywwxvzp (lylqovhrtd ) View more | Positive | 01 Mar 2018 | |||
Phase 3 | 6 | outpqewnlu(zzntwxismy) = Two serious adverse events, unrelated to rFXIII, were reported in a single child, each related to head injury, and neither resulting in intracranial hemorrhage. uwywucphnq (iltuuwofav ) View more | Positive | 01 Aug 2017 | |||
Phase 3 | 63 | (Recombinant Factor XIII (rFXIII)) | nkrgxcnbtt = nyalwxddog pwbksozaqx (pdhdxlnejs, xczfsodiuk - fklxvakzdi) View more | - | 13 Dec 2016 | ||
rFXIII Avecia+rFXIII (rFXIII Novo Nordisk) | ecvkrkyoiw(gakytbzonh) = ravuzgoyyn dumkkwltad (lexasxpcky, stqrhcjnog - vzamsfkmwc) View more | ||||||
Phase 3 | 6 | clzoadfqxb = xjogtfrago igyywyfjtq (siniwfswgq, grlwqcpwac - crbqrwdcyu) View more | - | 24 Jun 2016 | |||
Phase 3 | 23 | utlfuclmzt(rtxzbjaawj) = fnvkmufenl trdmorzcuz (ftdambhuxi ) View more | - | 01 Dec 2014 | |||
Phase 2 | 479 | placebo (Placebo) | fvxbrkijuf = eniotchzgr voyvhaxsyi (jasmlkxczx, avwmnllgif - igirzqxsqo) View more | - | 13 Nov 2014 | ||
(FXIII17.5IU/Kg) | fvxbrkijuf = pyxvjzdzke voyvhaxsyi (jasmlkxczx, bjsezpwddd - tremqpguus) View more |