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Alfimeprase · 5 trials · 6 indications
| Name | Type | Description |
|---|---|---|
| Alfimeprase | DRUG | single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD |
Inclusion Criteria: * Must give written informed consent * Ages 18 or older * Unable to withdraw at least 3 mL of blood from a central venous access device * Hemodynamically stable * Available for follow-up assessments Exclusion Criteria: * Inability to infuse at least 2 mL of saline through the ...
Alfimeprase is being developed to treat thrombosis, including occluded central and indwelling catheters and arterial occlusive diseases. It is intended to dissolve blood clots in these settings. The clinical program has studied it in adults with catheter occlusion and with acute peripheral arterial occlusion, where clot removal may help avoid surgery on leg arteries.
Alfimeprase targets fibrinogen alpha, beta, and gamma chains, known as FGA, FGB, and FGG. It is a hydrolytic enzyme, meaning it acts by cleaving these fibrinogen chain substrates. This fibrinogen-directed activity underlies its use in breaking down clot material in occluded catheters and occluded peripheral arteries.
Alfimeprase is being developed by Oruka Therapeutics, Inc., which trades under the ticker ORKA. The company is the sponsor associated with the drug's clinical development program in cardiovascular and thrombosis indications, including occluded catheters and arterial occlusive diseases.
Alfimeprase has reached Phase 3 clinical development. Its Phase 3 program includes completed studies in occluded central catheters and in arterial occlusive disease, along with an earlier Phase 2 study in acute peripheral arterial occlusion. It is an investigational agent and is not described as approved.
Alfimeprase has been studied in completed trials including NCT00346424 and NCT00322270, both Phase 3 studies in subjects with occluded catheters, and NCT00115999, a Phase 3 study in arterial occlusive disease of the leg. A Phase 2 trial, NCT00073554, evaluated thrombolysis in acute peripheral arterial occlusion. All are completed.
Across the Alfimeprase clinical program, total enrollment is approximately 400 participants. The Phase 3 catheter occlusion study NCT00346424 enrolled 300 subjects, and the Phase 3 arterial occlusive disease study NCT00115999 also enrolled 300, while the Phase 2 trial NCT00073554 enrolled 100. Trials enrolled adults aged 18 years and older.