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RiaSTAP
RiaSTAP is a fibrinogen concentrate that replaces or supplements fibrinogen to restore clotting ability in patients with fibrinogen deficiency.
RiaSTAP is a fibrinogen concentrate that replaces or supplements fibrinogen to restore clotting ability in patients with fibrinogen deficiency. Used for Congenital fibrinogen deficiency (afibrinogenemia or hypofibrinogenemia), Acquired fibrinogen deficiency.
At a glance
| Generic name | RiaSTAP |
|---|---|
| Also known as | Concentrated Fibrinogen, Fibrinogen Concentrate Human, Human Fibrinogen concentrate |
| Sponsor | Weill Medical College of Cornell University |
| Drug class | Fibrinogen concentrate |
| Target | Fibrinogen (Factor I) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
RiaSTAP provides exogenous fibrinogen (Factor I), a critical blood clotting protein, to patients with congenital or acquired fibrinogen deficiency or dysfunction. Fibrinogen is essential for thrombin-mediated clot formation and platelet aggregation. By restoring fibrinogen levels, the drug enables normal hemostasis and reduces bleeding risk in deficient patients.
Approved indications
- Congenital fibrinogen deficiency (afibrinogenemia or hypofibrinogenemia)
- Acquired fibrinogen deficiency
Common side effects
- Thromboembolism
- Fever
- Headache
- Allergic reactions
Key clinical trials
- Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery (PHASE3)
- Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients (PHASE4)
- GATT-Patch Versus TachoSil in Liver Surgery (NA)
- Fibrinogen Early In Severe Trauma StudY II (PHASE3)
- Administration of Fibrinogen Concentrate for Refractory Bleeding (PHASE2)
- NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery (NA)
- Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency (PHASE3)
- Adjusted Fibrinogen Replacement Strategy (PHASE3)
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:
- RiaSTAP CI brief — competitive landscape report
- RiaSTAP updates RSS · CI watch RSS
- Weill Medical College of Cornell University portfolio CI