Talphera is a pre-commercial specialty pharmaceutical company with one core asset: Niyad (nafamostat mesylate), a drug candidate being developed as a regional anticoagulant for use during continuous renal replacement therapy (CRRT) in hospital ICUs. CRRT is a slow, continuous form of dialysis used for critically ill patients with acute kidney injury. The central problem Niyad targets is circuit clotting — when blood flows through the dialysis machine, it tends to clot, interrupting therapy and causing blood loss. Current options are heparin, which anticoagulates the whole patient and raises bleeding risk, and citrate, which is used off-label, is complex to administer, and is contraindicated in roughly 43% of AKI patients. About 29% of CRRT cases use no anticoagulant at all. Nafamostat has a very short half-life of around 8 minutes, meaning it stays in the external circuit rather than entering the patient systemically — making it, if approved, the first FDA-approved anticoagulant designed specifically for regional circuit anticoagulation. Nafamostat has been approved in Japan and South Korea for over 30 years. Talphera is running a Phase 3 trial across up to 14 U.S. ICUs, with study completion expected in the first half of 2026 and a potential FDA approval targeted for late 2026. If approved, Talphera would sell Niyad directly to U.S. hospitals, targeting nephrologists and critical care physicians. Talphera has 12 employees, no revenue, and funds operations through equity financings.