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rThrombin
rThrombin is a recombinant human thrombin that directly converts fibrinogen to fibrin to promote blood clotting and hemostasis.
rThrombin is a recombinant human thrombin that directly converts fibrinogen to fibrin to promote blood clotting and hemostasis. Used for Control of bleeding in patients with Factor V deficiency, Hemostasis in surgical patients with coagulation disorders.
At a glance
| Generic name | rThrombin |
|---|---|
| Sponsor | ZymoGenetics |
| Drug class | Recombinant coagulation factor |
| Target | Fibrinogen (Factor I) |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
rThrombin is a recombinant version of the natural coagulation enzyme thrombin, which catalyzes the final step of the coagulation cascade by cleaving fibrinogen into fibrin monomers that polymerize to form stable clots. It is used topically or systemically to achieve rapid hemostasis in surgical and bleeding situations where conventional methods are insufficient or contraindicated. By bypassing upstream coagulation defects, it can be effective in patients with factor deficiencies or inhibitors.
Approved indications
- Control of bleeding in patients with Factor V deficiency
- Hemostasis in surgical patients with coagulation disorders
Common side effects
- Thrombosis
- Allergic reaction
- Fever
Key clinical trials
- Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation (PHASE4)
- Islet Transplant Alone in OMENtum (PHASE2)
- Safety and Efficacy of Topical Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis (PHASE3)
- Topical rhThrombin as an Adjunct to Hemostasis During Segmental Hepatectomy (PHASE1, PHASE2)
- Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants (PHASE4)
- Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis (PHASE3)
- Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis (PHASE4)
- Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting (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:
- rThrombin CI brief — competitive landscape report
- rThrombin updates RSS · CI watch RSS
- ZymoGenetics portfolio CI