Date: 2016-09-27
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Daiichi Sankyo (Japan)
Product: CS-3150 (esaxerenone)
Action
mechanism: mineralocorticoid receptor antagonist. CS-3150 (esaxerenone) is an orally administered, non-steroidal, selective inhibitor of the mineralocorticoid receptor. The binding of aldosterone to the mineralocorticoid receptor 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 damage2),3). 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. In March 2006, Daiichi Sankyo and Exelixis entered into a research collaboration agreement to discover, develop and commercialize novel therapies targeted for the mineralocorticoid receptor. Under the terms of the agreement, Daiichi Sankyo has exclusive development, manufacturing and commercialization rights for the compounds worldwide. CS-3150 is one of the in-licensed compounds identified during the research collaboration with Exelixis, and has subsequently been developed by Daiichi Sankyo.
Disease: essential hypertension
Therapeutic area: Cardiovascular diseases
Country: Japan
Trial
details: ESAX-HTN is a double blind study of CS-3150 to evaluate efficacy and safety compared to eplerenone in patients with essential hypertension. (NCT02890173)
Latest
news: * On September 27, 2016, Daiichi Sankyo announced that it has initiated a Phase 3 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 3 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.
