Analyst Outlook
Reasanz (serelaxin; Novartis) has not yet obtained approval in the US, Japan, or EU for the treatment
of acute decompensated heart failure (ADHF), despite its fast track and breakthrough therapy
designations from the US Food and Drug Administration (FDA). Although Reasanz was found to
improve symptoms and demonstrate a decrease in mortality in its pivotal Phase III study, the
methodology of the trial was questioned by regulators. Novartis is now focusing on the new RELAX-
AHF-2 study, which is expected to provide further clinical evidence of Reasanz’s clinical benefit and
support the drug’s approval. Positive results on Reasanz’s clinical value will reinforce the drug’s
competitive strengths and increase its commercial interest in the future.
Drug Overview
Reasanz is a recombinant version of human hormone relaxin-2 intended for the treatment of ADHF. It
exerts its effects by binding to one of two receptors, relaxin family peptide receptor 1 (RXFP1/LGR7) or
RXFP2 (LGR8), to activate a G protein-coupled receptor pathway on endothelial cells of the
vasculature. Receptor binding activates and upregulates the vascular endothelin B receptor, vascular
endothelial growth factor, and nitric oxide production. This process results in decreased systemic
vascular resistance, increased cardiac output, increased renal blood flow, and an increased glomerular
filtration rate. Reasanz is also thought to inhibit angiotensin II and endothelin, thereby causing
further systemic and renal vasodilation (Biomedtracker, 2016; Miyares and Davis, 2013).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Reasanz : Acute decompensated heart failure
LIST OF FIGURES
11 Figure 1: Reasanz for acute decompensated heart failure – SWOT analysis
12 Figure 2: Datamonitor Healthcare’s drug assessment summary of Reasanz for acute
decompensated heart failure
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of Reasanz for acute
decompensated heart failure
LIST OF TABLES
4 Table 1: Reasanz drug profile
6 Table 2: Reasanz Phase III trial in acute decompensated heart failure
7 Table 3: Reasanz efficacy and safety in subjects with acute decompensated heart failure
10 Table 4: Reasanz ongoing Phase III trial in acute decompensated heart failure