AcelRx Pharmaceuticals, Inc. announced that it is advancing Niyad?? (a lyophilized formulation of nafamostat) into a registrational study following the recent approval of an Investigational Device Exemption (IDE) submission to the United States Food and Drug Administration (FDA). This clinical trial will evaluate the safety and efficacy of Niyad to support a premarket approval application (PMA) expected to be submitted in the second half of 2024.

The single study will consist of 166 adult patients undergoing renal replacement therapy (RRT) who cannot tolerate heparin or are at risk for bleeding. If approved, Niyad would be the first-ever FDA-approved regional anticoagulant for the extracorporeal circuit in the U.S. Key secondary endpoints include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.