8 November 2022 - Guard Therapeutics today announces that the US FDA has granted RMC-035 (ROSgard) fast track designation for reducing the risk of an irreversible loss of kidney function, initiation of kidney replacement therapy or death following open-chest cardiac surgery in patients who are at increased risk for acute kidney injury.
The investigational drug RMC-035 is being developed as an intravenous short-term treatment against acute kidney injuries and is currently being evaluated in a comprehensive global Phase 2 study (AKITA) to document its renal protective effect in patients undergoing open cardiac surgery.