Drug Overview
Finerenone (Bayer) is a third-generation potent and selective oral, non-steroidal mineralocorticoid receptor antagonist (MRA).
It blocks the detrimental effects due to over-activation of the receptor by aldosterone and cortisol, which increases blood pressure and has been implicated in a number of other deleterious effects in the kidney, vasculature, and heart. While aldosterone secretion is inhibited by angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which are standard therapies for diabetic nephropathy (DN), aldosterone breakthrough, with increased levels, occurs in many patients.
Currently approved, generically available MRAs have shown reductions in proteinuria in chronic kidney disease (CKD) patients on ACE inhibitors or ARBs, but large-scale, long-term renal outcomes studies have been lacking due to concerns about side effects, such as hyperkalemia. The ongoing European PRIORITY study is evaluating the use of biomarkers to guide treatment with spironolactone for the prevention of albuminuria (30mg/g) in the first place, but the study is more of a proof of concept for further use of the assay in other clinical studies, because the assay's cost and complexity likely prohibit its use as a clinical diagnostic. The current MRAs have also demonstrated benefits on mortality/heart failure hospitalization in large heart failure outcomes studies, and the benefits were likewise seen in subgroups with renal dysfunction.
Finerenone was designed to have advantages over these current MRAs, with an improved benefit/risk profile, although patients with heart failure are being excluded from its placebo-controlled trials because MRAs are already recommended for that indication.
Finerenone is currently in Phase III development in the US, Japan, and EU as an add-on therapy to renin-angiotensin system inhibitors in DN (ClinicalTrials.gov identifiers: NCT02545049 and NCT02540993). Both Phase III trials include renal and cardiovascular (CV) outcomes, but one has renal outcomes as the primary endpoint and the other has CV outcomes.
Finerenone (Bayer) is a third-generation potent and selective oral, non-steroidal mineralocorticoid receptor antagonist (MRA).
It blocks the detrimental effects due to over-activation of the receptor by aldosterone and cortisol, which increases blood pressure and has been implicated in a number of other deleterious effects in the kidney, vasculature, and heart. While aldosterone secretion is inhibited by angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which are standard therapies for diabetic nephropathy (DN), aldosterone breakthrough, with increased levels, occurs in many patients.
Currently approved, generically available MRAs have shown reductions in proteinuria in chronic kidney disease (CKD) patients on ACE inhibitors or ARBs, but large-scale, long-term renal outcomes studies have been lacking due to concerns about side effects, such as hyperkalemia. The ongoing European PRIORITY study is evaluating the use of biomarkers to guide treatment with spironolactone for the prevention of albuminuria (30mg/g) in the first place, but the study is more of a proof of concept for further use of the assay in other clinical studies, because the assay's cost and complexity likely prohibit its use as a clinical diagnostic. The current MRAs have also demonstrated benefits on mortality/heart failure hospitalization in large heart failure outcomes studies, and the benefits were likewise seen in subgroups with renal dysfunction.
Finerenone was designed to have advantages over these current MRAs, with an improved benefit/risk profile, although patients with heart failure are being excluded from its placebo-controlled trials because MRAs are already recommended for that indication.
Finerenone is currently in Phase III development in the US, Japan, and EU as an add-on therapy to renin-angiotensin system inhibitors in DN (ClinicalTrials.gov identifiers: NCT02545049 and NCT02540993). Both Phase III trials include renal and cardiovascular (CV) outcomes, but one has renal outcomes as the primary endpoint and the other has CV outcomes.
Table of Contents
OVERVIEWDrug Overview
Product Profiles
finerenone: Diabetic nephropathy
LIST OF FIGURES
Figure 1: The authors drug assessment summary of finerenone for diabetic nephropathy
Figure 2: The authors drug assessment summary of finerenone for diabetic nephropathy
Figure 3: Finerenone sales for diabetic nephropathy across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
Table 1: Finerenone drug profile
Table 2: Finerenone Phase III trials in diabetic nephropathy
Table 3: Finerenone Phase IIb (ARTS-DN) results in diabetic nephropathy
Table 4: Finerenone for diabetic nephropathy – SWOT analysis
