coagulation factor xiii a-subunit (recombinant)
Trade name: Tretten
Approved
Dec 23, 2013
Catridecacog, sold under the brand name Tretten in the US and NovoThirteen in the EU) is a class of recombinant factor XIII A-subunit based biopharmaceutical medicine, indicated in patients with a rare clotting disorder, congenital factor XIII A-subunit deficiency, which is a kind of Factor XIII deficiency. The medication prevents bleeding in patients with this condition, and has been approved by the U.S. Food and Drug Administration (FDA) for this use in the US in 2014. It was brought to market by Novo Nordisk. — Wikipedia
Clinical trial activity
1 trials · 1 clinical orgs · 1 marketing orgs
Earliest trial started Mar 1, 2010 (NCT01082406)
Timeline
2000s
- Nov 6, 2003
Orphan Drug Designation
2010s
- Jan 1, 2010
Novo Nordisk — Earliest Phase 1 Sponsor(trial)
- Dec 23, 2013
Novo Nordisk — Earliest FDA Approval
- Dec 23, 2013
Novo Nordisk — NDA Organization
Indications
Approved for
Mechanism of action
- Coagulation factor XIIIEXOGENOUS PROTEIN
Coagulation factor XIII exogenous protein
- Coagulation factor XIIISupplementation
F13A1 supplementation
Approval history
- approvedDec 23, 2013
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaCatridecacog ↗
- ChEMBLCHEMBL2108282 ↗
Also known as
- blood coagulation factor xiii (synthetic human a-chain precursor)
- catridecacog
- catridecacog
- catridecacog
- catridecacog
- catridecacog
- catridecacog (genetical recombination)
- coagulation factor xiii
- coagulation factor xiii
- coagulation factor xiii a subunit (recombinant)
- coagulation factor xiii a-subunit (recombinant)
- coagulation factor xiii a-subunit (recombinant)
- factor xiii
- factor xiii
- factor xiii a-subunit (recombinant)
- human factor xiii (a2) homodimer (allele f13a*1b), recombinant dna origin
- novothirteen
- recombinant coagulation factor xiii
- recombinant coagulation factor xiii
- tretten
- tretten
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01082406 | Phase 1 | Mar 1, 2010 | Novo Nordisk |
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novo Nordisk | For profit | 1 | 1 | 1 | 2010 |
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Novo Nordisk | For profit | NDA | Dec 23, 2013 |