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Fibrin Sealant (FS) Grifols
Fibrin sealant is a topical hemostatic agent that forms a fibrin clot by combining fibrinogen and thrombin to achieve rapid hemostasis at surgical sites.
Fibrin sealant is a topical hemostatic agent that forms a fibrin clot by combining fibrinogen and thrombin to achieve rapid hemostasis at surgical sites. Used for Hemostasis and tissue adhesion during surgical procedures, Control of bleeding in general surgery, cardiovascular surgery, and other surgical applications.
At a glance
| Generic name | Fibrin Sealant (FS) Grifols |
|---|---|
| Sponsor | Grifols Biologicals, LLC |
| Drug class | Hemostatic agent / Fibrin sealant |
| Target | Fibrinogen (substrate for thrombin-mediated polymerization) |
| Modality | Biologic |
| Therapeutic area | Surgery / Hemostasis |
| Phase | Phase 3 |
Mechanism of action
Fibrin sealant works by mimicking the final steps of the coagulation cascade. When fibrinogen and thrombin components are mixed at the surgical site, thrombin converts fibrinogen into fibrin monomers, which polymerize to form a stable clot. This provides mechanical hemostasis and tissue adhesion without systemic absorption, making it useful for controlling bleeding during surgery.
Approved indications
- Hemostasis and tissue adhesion during surgical procedures
- Control of bleeding in general surgery, cardiovascular surgery, and other surgical applications
Common side effects
- Allergic reaction
- Infection at surgical site
- Thromboembolism (rare)
Key clinical trials
- A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants (PHASE3)
- Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery (PHASE3)
- Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries (PHASE3)
- Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries (PHASE3)
- Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis (PHASE2, 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:
- Fibrin Sealant (FS) Grifols CI brief — competitive landscape report
- Fibrin Sealant (FS) Grifols updates RSS · CI watch RSS
- Grifols Biologicals, LLC portfolio CI