www.fdanews.com/articles/174569-fda-awards-fast-track-designation-for-cardiorentis-heart-failure-drug
![heart-on-yellow.gif](https://www.fdanews.com/ext/resources/test/Device_Images/heart-on-yellow.gif?t=1577068037&width=430)
FDA Awards Fast Track Designation for Cardiorentis’ Heart Failure Drug
December 17, 2015
The FDA has granted Cardiorentis AG fast track designation for Ularitide for acute decompensated heart failure.
A natriuretic peptide, Ularitide currently is in Phase 3 development with primary endpoints of assessing a patient's symptoms and persistent or worsening heart failure within the first 48 hours following treatment.
The company says it is expecting top-line results from its Phase 3 trial next spring, and plans to file an NDA with the FDA and a European Marketing Authorization Application in the second half of 2016.