ESAX-HTN study Phase III pivotal study of non-steroidal, selective novel mineralocorticoid receptor blocker, esaxerenone has success for patients with essential hypertension in Japan. - Daiichi Sankyo.

Daiichi Sankyo Company, Limited announced that the primary endpoint has been achieved from ESAX-HTN study (Phase III pivotal study of non-steroidal, selective novel mineralocorticoid receptor (MR) blocker, esaxerenone (INN; code name: CS-3150) , for patients with essential hypertension in Japan. ESAX-HTN study is a double blind study of esaxerenone to evaluate efficacy and safety compared to eplerenone in patients with essential hypertension in Japan. Preliminary and ongoing analyses indicated no significant safety concerns in the ESAX-HTN study. The detailed study results will be disclosed at a future scientific meeting.

Esaxerenone (INN) (developmental code names CS-3150, XL-550) is a nonsteroidal antimineralocorticoid which was discovered by Exelixis and is now under development by Daiichi Sankyo Company for the treatment of hypertension, essential hypertension, hyperaldosteronism, and diabetic nephropathies. It acts as a highly selective silent antagonist of the mineralocorticoid receptor (MR), the receptor for aldosterone, with greater than 1,000-fold selectivity for this receptor over other steroid hormone receptors, and 4-fold and 76-fold higher affinity for the MR relative to the existing antimineralocorticoids spironolactone and eplerenone. As of 2017, esaxerenone is in phase III clinical trials for hypertension, essential hypertension, and hyperaldosteronism and is in phase II clinical trials for diabetic nephropathies.