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Guard Therapeutics granted Fast Track designation

The U.S. Food and Drug Administration has granted RMC-035 the 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.

“It is gratifying that our investigational drug is granted Fast Track designation by the FDA. AKI is a serious clinical problem, and we are pleased that the FDA recognizes the large medical need in the field. It also provides the opportunity to a closer dialogue with the agency and support in the continued development of our innovative investigational drug for the treatment of AKI associated with cardiac surgery, which in turn can lead to a faster way to market,” says Tobias Agervald, CEO of Guard Therapeutics.


The investigational drug RMC-035 is being developed as an intravenous short-term treatment against acute kidney injuries (AKI) 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. In addition, a Phase 1b study is underway in patients undergoing kidney transplantation.

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