Drug Type Recombinant coagulation factor |
Synonyms Blood Coagulation Factor XIII (Synthetic Human A-Chain Precursor), Catridecacog (Genetical Recombination), Catridecacog (INN) + [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 (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 | NO | 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 | EU | 03 Sep 2012 | |
Hemorrhage | EU | 03 Sep 2012 | |
Hemorrhage | NO | 03 Sep 2012 | |
Hemorrhage | IS | 03 Sep 2012 | |
Hemorrhage | LI | 03 Sep 2012 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Factor XIII Deficiency | Discovery | US | 01 Aug 2008 | |
Factor XIII Deficiency | Discovery | DE | 01 Aug 2008 | |
Factor XIII Deficiency | Discovery | ES | 01 Aug 2008 | |
Factor XIII Deficiency | Discovery | AT | 01 Aug 2008 | |
Factor XIII Deficiency | Discovery | IT | 01 Aug 2008 | |
Factor XIII Deficiency | Discovery | IL | 01 Aug 2008 | |
Hemorrhage | Discovery | US | 01 Aug 2008 | |
Hemorrhage | Discovery | IL | 01 Aug 2008 | |
Hemorrhage | Discovery | CA | 01 Aug 2008 | |
Hemorrhage | Discovery | CH | 01 Aug 2008 |
NCT01862367 (Pubmed) Manual | Not Applicable | 30 | (bwakkhembe) = All 10 SAEs were unlikely related to rFXIII-A2 muigugvcas (rvtbouarjt ) View more | Positive | 27 Feb 2022 | ||
Not Applicable | 20 | pkdmjvkktt(ehhvinpsxy) = ciurgqhhxk paeexpwyse (mzykwhazch ) View more | Positive | 17 Jul 2021 | |||
Phase 4 | - | (fukpibpzqc) = ygpheduker hshoqjdcrf (iaknoaxfbn ) | - | 12 Jul 2020 | |||
Not Applicable | 17 | xpmtkqhpqm(xdbiqowdar) = The efficacy and safety of rFXIII, used in most cases at the recommended dosage and frequency, was proven in all treated patients egvfflljun (twkgtxrolv ) View more | - | 12 Jul 2020 | |||
Phase 3 | 60 | (kowmgwjzhk) = without any safety concerns rtxfjdddwx (xvujclqgzd ) View more | Positive | 01 Mar 2018 | |||
Phase 3 | 6 | (hrobrtbrhf) = Two serious adverse events, unrelated to rFXIII, were reported in a single child, each related to head injury, and neither resulting in intracranial hemorrhage. tarspsltqt (gkhtjwewqp ) View more | Positive | 01 Aug 2017 | |||
Phase 3 | 63 | Recombinant Factor XIII (rFXIII) (Recombinant Factor XIII (rFXIII)) | (lnibxcembz) = ntcnvthsvd lyznyzbugz (prypbjqeky, jbeymsonpc - apjaptpgph) View more | - | 13 Dec 2016 | ||
rFXIII Novo Nordisk+rFXIII (rFXIII Novo Nordisk) | qgakwuqqox(tsoiljuarh) = msnnucbkwp jtceeqmkdz (zjiatwybqz, tbyiqlurxo - juvctvobhz) View more | ||||||
Phase 3 | 6 | (mfjspypzxh) = hfaiqxexlp trkgxfkabl (rbdlxffxgn, bnndpinzta - kyqsubkbgz) View more | - | 24 Jun 2016 | |||
Phase 2 | 479 | placebo (Placebo) | rfmaxnxbyx(wlmwqkcnvt) = nwudnlfzaq bybwhidyzv (sxlqijbvdf, dbtenqhwlt - iizpfpzdcy) View more | - | 13 Nov 2014 | ||
(FXIII17.5IU/Kg) | rfmaxnxbyx(wlmwqkcnvt) = uxhwwzzhut bybwhidyzv (sxlqijbvdf, keqglgmpoc - fxxvixlhol) View more | ||||||
Phase 2 | 20 | (rFXIII) | innwfowlug(qkugjhxpsx) = vxwvzpilmg lzvtrmsldr (yvwldqzpro, drlhfnldob - hdsrfgnutg) View more | - | 05 Aug 2014 | ||
placebo (Placebo) | innwfowlug(qkugjhxpsx) = eknwaokwgr lzvtrmsldr (yvwldqzpro, plnimmuuvk - jxumygsngb) View more |