Analyst Outlook
Ularitide’s (Cardiorentis) favorable results in its pivotal Phase III trial could be a key driver of uptake,
especially as Natrecor (nesiritide; Johnson & Johnson), its major marketed competitor, failed to show
added clinical value and benefit on survival. Ularitide has so far demonstrated beneficial effects in
acute decompensated heart failure (ADHF) patients such as symptom relief and vasodilation, while
still preserving renal function. It is likely that reconfirmation of ularitide’s clinical relevance in the
Phase III TRUE-AHF trial could boost the drug’s commercial potential and increase uptake in the
foreseeable future. Ularitide’s marketing company, Cardiorentis, has raised $60m to support the drug’s
development and has an experienced team to build a robust market strategy.
Drug Overview
Ularitide is a recombinant form of urodilatin, a natriuretic peptide synthesized in the distal tubular
cells of the kidney. It regulates renal sodium and water excretion through binding to natriuretic
peptide type A receptors and increasing intracellular cyclic guanosine monophosphate levels. Upon
stimulation of the particulate guanylate cyclase, ularitide regulates vascular perfusion, neurohormonal
activation, and renal function, providing effects of vasodilation, diuresis, and natriuresis. Urodilatin
has a terminal extension that brings resistance to biological inactivation by neutral endopeptidase,
whose activity is increased in ADHF. Ularitide also acts as a natural antagonist to the renin-
angiotensin-aldosterone system (Anker et al., 2015; Biomedtracker, 2016).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 ularitide : Acute decompensated heart failure
LIST OF FIGURES
8 Figure 1: Ularitide for acute decompensated heart failure – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of ularitide for acute
decompensated heart failure
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of ularitide for acute
decompensated heart failure
LIST OF TABLES
4 Table 1: Ularitide drug profile
7 Table 2: Ularitide Phase III trial in acute decompensated heart failure