Nafamostat - Niyad™
What is nafamostat?
An investigational broad-spectrum serine protease inhibitor with anticoagulant, anti-inflammatory, mucus clearing and potential anti-viral activities
Half-life of 8 minutes
Multiple potential indications given its proposed mechanism of action
Approved and used in Japan and South Korea for over 30 years
- Anticoagulation of the extracorporeal circuit
- Disseminated intravascular coagulation (DIC)
- Acute pancreatitis
Various studies performed outside the U.S. for COVID, Acute Respiratory Distress Syndrome (ARDS), Dengue fever and numerous other diseases
Niyad™ is our lead nafamostat product candidate
AcelRx is evaluating nafamostat as an anticoagulant for the extracorporeal circuit (blood path outside patient)
Niyad has numerous potential benefits compared to the standard of care
There are no FDA-approved regional anti-coagulants for the extracorporeal circuit
Niyad is being regulated as a device (as it works in the circuit and not the body)
- Granted FDA Breakthrough Device Designation status for use as a regional anticoagulant in patients receiving CRRT that cannot tolerate heparin or are at a higher risk of bleeding, providing regulatory and developmental benefits
Approval for a single registrational study planned in H2 2023 with endpoints agreed with the FDA
- EUA submission planned for H1 2023
ICD-10 CMS procedural code already received for reimbursement
Niyad peak sales estimated at more than $200 million
