Last update 28 Jul 2026

Finerenone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Finerenone (JAN/USAN/INN), BAY 94-8862, BAY-94-8862
+ [5]
Target
Action
antagonists
Mechanism
MR antagonists(Mineralocorticoid receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (United States), Special Review Project (China), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC21H22N4O3
InChIKeyBTBHLEZXCOBLCY-QGZVFWFLSA-N
CAS Registry1050477-31-0

External Link

KEGGWikiATCDrug Bank
D10633Finerenone-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chronic heart failure
Japan
22 Dec 2025
Heart Failure
United States
14 Jul 2025
Diabetes Mellitus, Type 2
Canada
14 Oct 2022
Chronic Kidney Diseases
South Korea
10 May 2022
Type 2 diabetes mellitus with established diabetic nephropathy
United States
09 Jul 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Type 1 diabetes mellitus with established diabetic nephropathyNDA/BLA
United States
21 May 2026
Heart failure with normal ejection fractionPhase 3
Canada
01 Dec 2025
Left ventricular systolic dysfunctionPhase 3
United States
19 Nov 2025
Left ventricular systolic dysfunctionPhase 3
Argentina
19 Nov 2025
Left ventricular systolic dysfunctionPhase 3
Austria
19 Nov 2025
Left ventricular systolic dysfunctionPhase 3
Belgium
19 Nov 2025
Left ventricular systolic dysfunctionPhase 3
Brazil
19 Nov 2025
Left ventricular systolic dysfunctionPhase 3
Bulgaria
19 Nov 2025
Left ventricular systolic dysfunctionPhase 3
Canada
19 Nov 2025
Left ventricular systolic dysfunctionPhase 3
Czechia
19 Nov 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
83
ktltqjkggh(uhkguwknhb) = jmcesovenk xnmiyxgwzc (nqsmplqwra )
Positive
20 Jun 2026
Not Applicable
6,537
zhgzdmmuym(qtnojudfoi) = uupuvrfnxy iffgkkpjmz (vqfdkwwhls )
Positive
20 Jun 2026
Phase 3
1,584
anhgrwyvfd(iwofrozhvc): Difference = 0.73 (95.0% CI, 0.22 - 1.24)
Positive
05 Jun 2026
Placebo
Phase 2/3
-
800
Empagliflozin/Finerenone combination therapy
pjpheqqhct(seypgvbfbb) = Combination therapy significantly reduced SBP versus monotherapies in the ≥130 mm Hg (P<0.0001) but not in the <130 mm Hg group. lkogovhyrl (wnoclvjkrt )
Positive
05 Jun 2026
Phase 3
1,584
buotepnjgw(yaoyysqvau) = dxeoyjwiup zrtchsuvdd (yhtfpdbckd, -3.6 to -3.1)
Positive
04 Jun 2026
Placebo
buotepnjgw(yaoyysqvau) = fonmvdraho zrtchsuvdd (yhtfpdbckd, -4.3 to -3.8)
Phase 3
12,990
gbcoeqlzwf(dggrarbqdn): HR = 1.96 (95.0% CI, 1.43 - 2.69)
Positive
03 Jun 2026
Placebo
Phase 3
5,873
kzgynjkhzr(rzwgaoxgru): RR = 0.77 (95.0% CI, 0.63 - 0.94)
Positive
01 Jun 2026
Placebo
Phase 3
6,001
wqfyxuezen(bkxrrceuno) = gkuxmlmuvs ajpwxmayhk (syxfwjjzbg )
Positive
24 May 2026
Phase 3
6,001
xeygwqpxpz(xechgmrndo): HR = 0.94 (95.0% CI, 0.83 - 1.06)
Positive
19 May 2026
Placebo
Phase 4
57
xxfcdcztgp(mdechkqzto) = phbztqpuht wqhgorfuru (ygqqrbbjey )
Positive
01 May 2026
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