Last reviewed · How we verify
Novothirteen (CATRIDECACOG)
At a glance
| Generic name | CATRIDECACOG |
|---|---|
| Sponsor | Novo Nordisk |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2012 |
Approved indications
- Hereditary factor XIII A subunit deficiency
Common side effects
Key clinical trials
- Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study
- Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 (PHASE3)
- Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery (PHASE2)
- Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency (PHASE3)
- Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency (PHASE3)
- Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers (PHASE1)
- Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass (PHASE1)
- Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Novothirteen CI brief — competitive landscape report
- Novothirteen updates RSS · CI watch RSS
- Novo Nordisk portfolio CI