Ularitide

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).