FDA News

FDA grants fast track designation for HFpEF medication

Ironwood Pharmaceuticals announced that praliciguat for the treatment of patients with HF with preserved ejection fraction has been granted fast track designation by the FDA.

Praliciguat is an investigational soluble guanylate cyclase simulator that is administered orally, according to a press release from the company. Phase 2 clinical trials are currently being performed on the drug.

“An ever-increasing number of people are suffering from HFpEF, a disease characterized by exercise intolerance, frequent hospitalizations and increased risk for death, yet there are no approved treatment options,” Christopher Wright, MD, PhD, senior vice president of global development and chief development officer at Ironwood, said in the press release. “We believe praliciguat has the potential to be a new treatment option for these patients and are researching its ability to provide multidimensional impact on this disease by increasing tissue blood flow and decreasing cardiac vascular inflammation and fibrosis.”

Ironwood is enrolling patients in the CAPACITY-HFpEF trial, a randomized, double-blind, placebo-controlled phase 2 trial that will evaluate the safety and effectiveness of praliciguat in patients with HFpEF, according to the release. The company is expecting to enroll approximately 175 patients, and topline data is expected in the second half of 2019.

Disclosure: Wright is an employee of Ironwood.

Ironwood Pharmaceuticals announced that praliciguat for the treatment of patients with HF with preserved ejection fraction has been granted fast track designation by the FDA.

Praliciguat is an investigational soluble guanylate cyclase simulator that is administered orally, according to a press release from the company. Phase 2 clinical trials are currently being performed on the drug.

“An ever-increasing number of people are suffering from HFpEF, a disease characterized by exercise intolerance, frequent hospitalizations and increased risk for death, yet there are no approved treatment options,” Christopher Wright, MD, PhD, senior vice president of global development and chief development officer at Ironwood, said in the press release. “We believe praliciguat has the potential to be a new treatment option for these patients and are researching its ability to provide multidimensional impact on this disease by increasing tissue blood flow and decreasing cardiac vascular inflammation and fibrosis.”

Ironwood is enrolling patients in the CAPACITY-HFpEF trial, a randomized, double-blind, placebo-controlled phase 2 trial that will evaluate the safety and effectiveness of praliciguat in patients with HFpEF, according to the release. The company is expecting to enroll approximately 175 patients, and topline data is expected in the second half of 2019.

Disclosure: Wright is an employee of Ironwood.