To date approximately 7,000 patients have been treated with ularitide in Europe. Of these, approximately 5,550 patients have received ularitide on a compassionate use basis and 1,370 subjects have received ularitide in clinical trials. These trials included Phase I studies in healthy subjects, two studies in patients with acute heart failure (AHF), one study in patients with renal failure and one study in patients with chronic bronchial asthma.
Ularitide has been studied for the treatment of acute heart failure (AHF) in two double-blind, placebo-controlled Phase I and Phase II studies (Safety and efficacy of an Intravenous placebo controlled Randomised Infusion of Ularitide in a prospective double – blind Study in patients with symptomatic, decompensated chronic heart failure – SIRIUS I and SIRIUS II). To find out more about SIRIUS I and SIRIUS II trials, click here. Cardiorentis AG is now recruiting patients in a Phase III trial – TRUE-AHF (TRial of Ularitide’s Efficacy and safety in patients with Acute Heart Failure). To find out more about TRUE-AHF, click here.