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Pathogen-Reduced Cryoprecipitate
Pathogen-Reduced Cryoprecipitate is a Blood product / Hemostatic agent Biologic drug developed by Weill Medical College of Cornell University. It is currently FDA-approved for Fibrinogen replacement in patients with congenital or acquired fibrinogen deficiency, Massive transfusion and disseminated intravascular coagulation (DIC), Perioperative bleeding management.
Pathogen-reduced cryoprecipitate is a blood product containing fibrinogen, von Willebrand factor, fibronectin, and other clotting factors that have been treated to inactivate pathogens while preserving hemostatic function.
Pathogen-Reduced Cryoprecipitate is used to treat conditions such as hypofibrinogenemia, bleeding, and hemorrhage, particularly in patients undergoing liver transplant surgery. It is a type of cryoprecipitate that has been pathogen-reduced, although the exact mechanism of action is not specified as a small molecule modality.
At a glance
| Generic name | Pathogen-Reduced Cryoprecipitate |
|---|---|
| Sponsor | Weill Medical College of Cornell University |
| Drug class | Blood product / Hemostatic agent |
| Modality | Biologic |
| Therapeutic area | Hematology / Hemostasis |
| Phase | FDA-approved |
Mechanism of action
Cryoprecipitate is the cold-insoluble fraction of plasma containing high concentrations of fibrinogen and von Willebrand factor. The pathogen-reduction process uses solvent-detergent or photochemical treatment to inactivate viruses, bacteria, and other pathogens while maintaining the functional clotting proteins. This product is used to restore fibrinogen and other hemostatic factors in patients with deficiencies or consumption coagulopathy.
Approved indications
- Fibrinogen replacement in patients with congenital or acquired fibrinogen deficiency
- Massive transfusion and disseminated intravascular coagulation (DIC)
- Perioperative bleeding management
Common side effects
- Thrombosis
- Allergic reaction
- Fever
- Transfusion-related acute lung injury (TRALI)
Key clinical trials
- Fibrinogen in Liver Transplant (PHASE4)
- Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding (PHASE4)
- Comparative Effectiveness of INTERCEPT Fibrinogen Complex (IFC) and Cryoprecipitate-AHF (Cryo-AHF) for Treatment of Trauma Associated Hemorrhage
- Fibrinogen in Liver Transplant Subjects (PHASE4)
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:
- Pathogen-Reduced Cryoprecipitate CI brief — competitive landscape report
- Pathogen-Reduced Cryoprecipitate updates RSS · CI watch RSS
- Weill Medical College of Cornell University portfolio CI
Frequently asked questions about Pathogen-Reduced Cryoprecipitate
What is Pathogen-Reduced Cryoprecipitate?
How does Pathogen-Reduced Cryoprecipitate work?
What is Pathogen-Reduced Cryoprecipitate used for?
Who makes Pathogen-Reduced Cryoprecipitate?
What drug class is Pathogen-Reduced Cryoprecipitate in?
What development phase is Pathogen-Reduced Cryoprecipitate in?
What are the side effects of Pathogen-Reduced Cryoprecipitate?
Related
- Drug class: All Blood product / Hemostatic agent drugs
- Manufacturer: Weill Medical College of Cornell University — full pipeline
- Therapeutic area: All drugs in Hematology / Hemostasis
- Indication: Drugs for Fibrinogen replacement in patients with congenital or acquired fibrinogen deficiency
- Indication: Drugs for Massive transfusion and disseminated intravascular coagulation (DIC)
- Indication: Drugs for Perioperative bleeding management
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing