FDA/CDC

FDA grants praliciguat Fast Track Designation for HFpEF


 

The Food and Drug Administration has granted praliciguat Fast Track Designation for treatment of patients with heart failure with preserved ejection fraction (HFpEF), according to its developer Ironwood.

FDA icon

A phase 2, randomized, double-blind, placebo-controlled trial is currently enrolling patients to evaluate praliciguat as a treatment for HFpEF. The trial aims to enroll about 175 patients and intends to evaluate safety and efficacy, and topline data is expected later in 2019.

Praliciguat is an oral, once-daily, soluble guanylate cyclase (sGC) stimulator. It is being studied in patients with diabetic nephropathy and in patients with HFpEF. The condition affects an estimated 3 million Americans, but there are no approved therapies at this time to treat it; however, praliciguat may have the potential to treat the underlying causes by improving nitric oxide signaling, according to the press release from Ironwood.

Recommended Reading

Generic, brand-name levothyroxine have similar cardiovascular outcomes
MDedge Endocrinology
CV outcomes better with SGLT2 inhibitor than DPP4 inhibitor in T2DM study
MDedge Endocrinology
VIDEO: U.S. hypertension guidelines reset threshold to 130/80 mm Hg
MDedge Endocrinology
Aim for BP a bit above SPRINT
MDedge Endocrinology
Empagliflozin’s heart failure benefits linked to volume drop
MDedge Endocrinology
Learn ‘four Ds’ approach to heart failure in diabetes
MDedge Endocrinology
Overweight and obese individuals face greater cardiovascular morbidity
MDedge Endocrinology
Major message: Most heart failure is preventable
MDedge Endocrinology
MDedge Daily News: Why most heart failure may be preventable
MDedge Endocrinology
MDedge Daily News: Can a nasal spray reverse suicidality?
MDedge Endocrinology