Daiichi Sankyo initiates Phase III trial for CS-3150 (esaxerenone) as a treatment for hypertension.

Daiichi Sankyo Company, Limited announced that it has initiated a Phase III pivotal study of CS-3150 (esaxerenone (r-INN)), its non-steroidal, selective novel mineralocorticoid receptor (MR) antagonist, for patients in Japan with essential hypertension. ESAX-HTN is a phase III randomized, double-blind, 3-arm, parallel group comparison study with eplerenone as active control in patients with essential hypertension in Japan. The primary endpoint is sitting SBP/DBP change from baseline after 12-week treatment, and the secondary endpoint is mean 24hr SBP/DBP change from baseline after 12-week treatment. Nine hundred and thirty (930) patients are planned to be enrolled at approximately 40 clinical sites in Japan.

Esaxerenone (r-INN)) is an orally administered, non-steroidal, selective inhibitor of the mineralocorticoid receptor. The binding of aldosterone to the MR plays a central role in the regulation of plasma sodium (Na+), extracellular potassium (K+) and arterial blood pressure by acting on the collecting ducts in nephrons. As recently reported, aldosterone is regarded as a potent mediator of organ damage. CS-3150 may have a role in preventing these organ damaging effects. CS-3150?is currently in development in hypertension and diabetic nephropathy in Japan.