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FXIII Concentrate (Human)
FXIII Concentrate replaces deficient coagulation Factor XIII to restore normal blood clot cross-linking and stabilization.
FXIII Concentrate replaces deficient coagulation Factor XIII to restore normal blood clot cross-linking and stabilization. Used for Congenital Factor XIII deficiency (FXIII deficiency), Perioperative prophylaxis in Factor XIII-deficient patients.
At a glance
| Generic name | FXIII Concentrate (Human) |
|---|---|
| Also known as | Fibrogammin®-P, Fibrogammin-P |
| Sponsor | CSL Behring |
| Drug class | Coagulation factor concentrate |
| Target | Coagulation Factor XIII (F13A1) |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Factor XIII (fibrin-stabilizing factor) is a transglutaminase that cross-links fibrin polymers to strengthen and stabilize blood clots. Patients with FXIII deficiency have impaired clot formation and increased bleeding risk. This concentrate provides exogenous FXIII to restore normal hemostatic function and prevent spontaneous or excessive bleeding.
Approved indications
- Congenital Factor XIII deficiency (FXIII deficiency)
- Perioperative prophylaxis in Factor XIII-deficient patients
Common side effects
- Thrombosis/thromboembolic events
- Hypersensitivity reactions
- Fever
- Headache
Key clinical trials
- Clinical Trial of Factor XIII (FXIII) Concentrate (NA)
- An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency (PHASE3)
- A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency (PHASE3)
- A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency (PHASE2)
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:
- FXIII Concentrate (Human) CI brief — competitive landscape report
- FXIII Concentrate (Human) updates RSS · CI watch RSS
- CSL Behring portfolio CI