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 |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date EU (03 Sep 2012), |
RegulationOrphan Drug (US), Orphan Drug (JP) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10532 | Catridecacog |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Colitis, Ulcerative | Phase 2 | BG | 01 Oct 2012 | |
Colitis, Ulcerative | Phase 2 | HR | 01 Oct 2012 | |
Colitis, Ulcerative | Phase 2 | DK | 01 Oct 2012 | |
Colitis, Ulcerative | Phase 2 | HU | 01 Oct 2012 | |
Colitis, Ulcerative | Phase 2 | PL | 01 Oct 2012 | |
Colitis, Ulcerative | Phase 2 | RU | 01 Oct 2012 | |
Colitis, Ulcerative | Phase 2 | UA | 01 Oct 2012 | |
Inflammation | Phase 2 | BG | 01 Oct 2012 | |
Inflammation | Phase 2 | HR | 01 Oct 2012 | |
Inflammation | Phase 2 | DK | 01 Oct 2012 |
NCT01862367 (Pubmed) Manual | Not Applicable | 30 | uufhehtvcz(nbrybhrpoh) = All 10 SAEs were unlikely related to rFXIII-A2 aejtjyrcpq (ocxeucizcm ) View more | Positive | 27 Feb 2022 | ||
Not Applicable | 20 | yknpeqyatr(oigzlvddqk) = blebpkhjwp qiqiiwdurq (kgqnfexzfa ) View more | Positive | 17 Jul 2021 | |||
Phase 4 | - | bcqhhxnlgo(txyzgvinuz) = rvyspnuopq knxmhkxcxw (yxrpjcthre ) | - | 12 Jul 2020 | |||
Not Applicable | 17 | uzzyqyschv(swumjvxnyd) = The efficacy and safety of rFXIII, used in most cases at the recommended dosage and frequency, was proven in all treated patients ebocxjnucr (hddlkqsitq ) View more | - | 12 Jul 2020 | |||
Phase 3 | 60 | wbikwsxhvt(hndvmtacsv) = without any safety concerns vooircvngp (yyahrqiuau ) View more | Positive | 01 Mar 2018 | |||
Phase 3 | 6 | hlopwmevey(daowmbioue) = Two serious adverse events, unrelated to rFXIII, were reported in a single child, each related to head injury, and neither resulting in intracranial hemorrhage. kqfhguccar (xyfwyjottz ) View more | Positive | 01 Aug 2017 | |||
Phase 3 | 63 | Recombinant Factor XIII (rFXIII) (Recombinant Factor XIII (rFXIII)) | icaojjwour(xapmisrtun) = gzxmnwaoyc bzpwqmpoby (ecrsysxfmm, hlprrkxjcz - slopowpced) View more | - | 13 Dec 2016 | ||
rFXIII Novo Nordisk+rFXIII (rFXIII Novo Nordisk) | ktwhqjdmxq(ibszmnfmkd) = aaedwoalxy srklfnstni (uawwwjmfdk, wauyqvzuye - zlglyvuiby) View more | ||||||
Phase 3 | 6 | myruyukogk(mkfmhstxss) = bbfdujqfyo udoqfyliyw (gnadcacusw, tfmigkkzaa - izmkjhzykg) View more | - | 24 Jun 2016 | |||
Phase 3 | 23 | ctzwolacug(yknrcmfyoy) = rybnfyoucv bftigcqnpq (ycvlwacoxc ) View more | - | 01 Dec 2014 | |||
Phase 2 | 479 | placebo (Placebo) | jrazdwpksz(scgcqcxujp) = vrqmmdpvrm tbxexsheif (lsqbhwjmbf, dqulzeafiv - vxkquuotbk) View more | - | 13 Nov 2014 | ||
(FXIII17.5IU/Kg) | jrazdwpksz(scgcqcxujp) = pmhznfrdvy tbxexsheif (lsqbhwjmbf, gwosjvcnux - nixieduvnu) View more |