The Food and Drug Administration (FDA) has granted Fast Track Designation to praliciguat for the treatment of heart failure with preserved ejection fraction (HFpEF) patients.

Praliciguat (Ironwood Pharmaceuticals) is an orally administered, soluable guanylate cyclase (sGC) stimulator. The Company is currently enrolling patients in a randomized, double-blind, placebo-controlled Phase 2 trial; they expect to enroll 175 in total. To be eligible, patients will need to have heart failure with ejection fraction ≥40%, as well as meet other criteria. Topline data from the trial are expected in the second half of 2019.

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“The Fast Track Designation underscores the seriousness of this disease and that praliciguat has potential to address unmet needs in HFpEF,” said Christopher Wright, MD, PhD, CDO of Ironwood. “We look forward to working closely with the FDA to rapidly progress the development of praliciguat for the treatment of HFpEF.”

In addition to the HFpEF indication, praliciguat is being investigated in patients with diabetic nephropathy in a Phase 2 trial.

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