Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | NovoThirteen | — | 2012-09-03 | europa.eu ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT01153997 | Jun → Aug 2010 | hemorrhagic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01082406 | Mar → Jul 2010 | congenital factor XIII deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT02239146 | Oct 2005 → Jan 2008 | acquired coagulation factor deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01848002 | May → Aug 2003 | congenital factor XIII deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT00056589 | Mar → Oct 2003 | congenital factor XIII deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01847989 | Jan → May 2003 | congenital factor XIII deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 22 trials · 2 missed | ||||||
| Phase 2 | NCT01706159 | Oct 2012 → Jul 2013 | ulcerative colitis | Novo Nordisk A/S | Terminated | Missed primary |
| Phase 2 | NCT00914589 | Jul 2009 → Feb 2011 | hemorrhagic disease | Novo Nordisk A/S | Completed | Missed primary |
| Phase 34 trials | ||||||
| Phase 3 | NCT01253811 | Jan 2011 → Mar 2015 | congenital factor XIII deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT01230021 | Nov 2010 → Jan 2012 | congenital factor XIII deficiency, inherited blood coagulation disorder | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00978380 | Sep 2009 → Oct 2015 | congenital factor XIII deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00713648 | Aug 2008 → Apr 2010 | congenital factor XIII deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | catridecacog | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02239146 ↗ |
| Known as | Novothirteen | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108282 ↗ |
| Known as | recombinant factor XIII | “The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of...” NCT01230021 ↗4“The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.” NCT01847989 ↗ “The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency.” NCT00713648 ↗ “Single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv (into the vein)” NCT01082406 ↗ “multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.” NCT01848002 ↗ |
| Known as | rFXIII | “The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of...” NCT01230021 ↗6“The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial...” NCT02239146 ↗ “The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in patients with congenital...” NCT00056589 ↗ “Catridecacog (recombinant factor XIII, rFXIII) will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week at a dose of 35 IU/kg” NCT01706159 ↗ “The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.” NCT01847989 ↗ “The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency.” NCT00713648 ↗ “multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.” NCT01848002 ↗ |
| Known as | Tretten | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108282 ↗ |
| Action | Restore | “Recombinant FXIII appears to be a safe and potentially effective alternative for FXIII replacement in patients with FXIII deficiency.” PMID 16556896 ↗ Mar 2006 |
| Modality | Protein / enzyme biologic | “human recombinant FXIII-A2 (rFXIII-A2) homodimer” PMID 16556896 ↗ Mar 2006 |
| Route | Intravenous | “rFXIII administered intravenously (IV)” NCT00056589 ↗ |
| Target | F13A1 | “Coagulation factor XIII exogenous protein” CHEMBL2108282 ↗ |