Esaxerenone: First Global Approval
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ADISINSIGHT REPORT
Esaxerenone: First Global Approval Sean Duggan1
© Springer Nature Switzerland AG 2019
Abstract Esaxerenone (MINNEBRO™)—a novel oral, non-steroidal, selective mineralocorticoid receptor blocker—is being developed by Daiichi Sankyo for the treatment of hypertension and diabetic nephropathies. In January 2019, based on positive results from a phase III trial conducted in Japan in patients with essential hypertension, esaxerenone received marketing approval in Japan for the treatment of hypertension. This article summarizes the milestones in the development of esaxerenone leading to this first global approval for the treatment of hypertension.
1 Introduction
1.1 Company Agreements
Daiichi Sankyo are developing esaxerenone (MINNEBRO™), a novel oral, non-steroidal, selective mineralocorticoid receptor blocker, for the treatment of hypertension and diabetic nephropathies. Excessive mineralocorticoid receptor activation by endogenous ligands such as aldosterone has been shown to play an important role in the development of hypertension, as well as progression of nephropathy and cardiovascular disease [1–4]. Esaxerenone is thought to exert an antihypertensive effect by blocking mineralocorticoid receptor activation. Esaxerenone was approved in Japan for the treatment of hypertension on the 8th January 2019 [4, 5] on the basis of positive results from a phase III trial in Japanese patients with essential hypertension (NCT02890173; ESAX-HTN) [6]. The drug is available as 1.25, 2.5 and 5 mg tablets, with the recommended dosage of esaxerenone being 2.5 mg once daily administered orally; if the effect is insufficient, the dosage can be increased to 5 mg [4]. Clinical development of esaxerenone for the treatment of diabetic nephropathies is underway in Japan.
In March 2006, Sankyo Co., Ltd, a subsidiary of Daiichi Sankyo, entered into a research collaboration agreement with Exelixis Inc. to develop and commercialise novel therapies targeting the mineralocorticoid receptor [7]. Daiichi Sankyo obtained an exclusive, worldwide licence to certain intellectual property primarily relating to compounds that modulate the mineralocorticoid receptor, including esaxerenone [7, 8]. After completion of the research term, Sankyo Co., Ltd has assumed responsibility for all further clinical and regulatory development of the drug. In return, Exelixis received a $US20 million upfront payment and will receive research and development funding.
This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through preclinical and clinical studies to market launch and beyond. * Sean Duggan [email protected] 1
Springer, Private Bag 65901, Mairangi Bay, 0754 Auckland, New Zealand
2 Scientific Summary 2.1 Pharmacodynamics Esaxerenone, a selective nonsteroidal mineralocorticoid receptor antagonist, has been shown to bind to mineralocorticoid receptors, thereby inhibiting aldosterone binding and activation of the
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