Last reviewed · How we verify
recombinant factor XIII
At a glance
| Generic name | recombinant factor XIII |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- A Study of Safety and Effectiveness of NovoThirteen® (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan
- 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)
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 |
|---|---|
| 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:
- recombinant factor XIII CI brief — competitive landscape report
- recombinant factor XIII updates RSS · CI watch RSS
- Novo Nordisk A/S portfolio CI