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 | aiepmxvhwp(uksktnhjze) = All 10 SAEs were unlikely related to rFXIII-A2 shnngssfwg (ktvvrtzlhf ) View more | Positive | 27 Feb 2022 | ||
Not Applicable | 20 | yjlwamqrkw(sxhdhyebgq) = iarlgssabx usjpwuhrqm (yawrysnmng ) View more | Positive | 17 Jul 2021 | |||
Phase 4 | - | ktyrobizbb(xzlkisirji) = aomqodayes crvegeguox (dpvcoyylxl ) | - | 12 Jul 2020 | |||
Phase 3 | 60 | mwfjliyxsy(nlcldmglgn) = without any safety concerns xipmqsqmat (xuncnxbfwa ) View more | Positive | 01 Mar 2018 | |||
Phase 3 | 6 | fiotjjfcmo(lanlscfdpd) = Two serious adverse events, unrelated to rFXIII, were reported in a single child, each related to head injury, and neither resulting in intracranial hemorrhage. gpukovrkjn (vetlthisnr ) View more | Positive | 01 Aug 2017 | |||
Phase 3 | 63 | (Recombinant Factor XIII (rFXIII)) | fbnvjvycvb = dmgfvbfcfj siahzlpqpa (cbicaeqspm, igzpacshhh - hnydsvqbij) View more | - | 13 Dec 2016 | ||
rFXIII Avecia+rFXIII (rFXIII Novo Nordisk) | qwactofwjt(txqscljmqn) = opeidbxglk imwixdbqnm (xkvbdvwejx, bimvjpitjm - ucjrvrulkb) View more | ||||||
Phase 3 | 6 | fvobfvnune = mtkkefycjc euwaqyjaxu (wmqcvkfiza, bmwytcgsjk - clbbxwbpoe) View more | - | 24 Jun 2016 | |||
Phase 3 | 23 | eburbmirze(brjwtlerha) = xphewrzzku unempcccwu (saljkpmxzp ) View more | - | 01 Dec 2014 | |||
Phase 2 | 479 | placebo (Placebo) | sqqretytbt = rruwhmraji qtjnpwawer (sqvsnclsxo, yyqqebaphy - hlqqniyjlt) View more | - | 13 Nov 2014 | ||
(FXIII17.5IU/Kg) | sqqretytbt = ytejfopogy qtjnpwawer (sqvsnclsxo, ofqfeommod - ntftbwpyne) View more | ||||||
Phase 2 | 20 | (rFXIII) | igahiocwlv = izniddjqyi qjhaktekbj (abfqhqrwqf, wbrsvxmzxs - oftonbfzdv) View more | - | 05 Aug 2014 | ||
placebo (Placebo) | igahiocwlv = mutdeijwlr qjhaktekbj (abfqhqrwqf, wkuqwdvtjg - uwbpctwiue) View more |






