After positive Phase III trial, Daiichi Sankyo plans filing for new hypertension drug

San Francisco’s Exelixis and Tokyo’s Daiichi Sankyo have reported positive Phase III results from a Japanese trial of esaxerenone.

The trial met its primary endpoint of change from baseline in sitting systolic blood pressure (SBP) / diastolic blood pressure (DBP) after 12 weeks, in patients with essential hypertension.

The candidate is the result of a 2006 research and commercialization agreement between the firms, targeting the mineralocorticoid receptor.

Under the terms of the deal, Daiichi has exclusive global rights to develop and commercialize the compounds. The company says it will file for regulatory approval in Japan in this indication early next year.

Separately, Daiichi Sankyo also announced the initiation of a pivotal trial of esaxerenone in patients with diabetic nephropathy.