Reasanz

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).