Last update 04 Mar 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), Priority Review (United States), Special Review Project (China)
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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
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
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
Left ventricular systolic dysfunctionPhase 3
Finland
19 Nov 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
8,370
kkdwmwcxzj(punnmfpfth): HR = 0.82 (95.0% CI, 0.68 - 0.99), P-Value = 0.043
Positive
01 Apr 2026
Placebo
Phase 3
6,001
agyjxqjiwn(tyenvecehw): HR = 0.94 (95.0% CI, 0.83 - 1.06)
Positive
16 Feb 2026
Placebo
Phase 2
Heart Failure
total bilirubin | alkaline phosphatase | alanine aminotransferase ...
6,001
ubygqurezr(thhimwtjno) = ozzxxfdrww hxtsvbcjhw (krssmxghqz )
Positive
01 Feb 2026
Phase 3
5,873
qsqvuahkty(sqapmttuka): RR = 0.77 (95.0% CI, 0.63 - 0.94)
Positive
01 Feb 2026
Placebo
Phase 4
57
vkuvygtodj(nyxuweseyk) = bvfwsmmdns duytrfehaj (hivaqnavtj )
Positive
22 Jan 2026
Phase 3
-
ngbusgdciy(oorueewzvq) = yrfpnqnjzt sngeeocjtc (baawrqsbyu )
Positive
14 Jan 2026
Placebo
ngbusgdciy(oorueewzvq) = cxzhcjxgdd sngeeocjtc (baawrqsbyu )
Phase 3
242
daphwcbhqe(fnkfsbmxir) = xnunrygzsh msjuovcorg (ipqbnzwqdl )
Met
Positive
06 Nov 2025
Placebo + SOC
zopivnrkcl(rmivfejloh) = ascyhxxrbn wwlczclecy (kfmiqyucmg )
Not Applicable
22
(Diabetic Nephropathy)
xszocytilm(xbvbbqdmyx) = aykrmzqzcd hgdlcvyokt (hsfmknuevs )
Positive
06 Nov 2025
(Non-Diabetic Renal Disease)
wydgkfnbls(slsypinzin) = wkzqnerkap eftorngsoh (omcidrytdf )
Phase 3
242
xundfputen(lgatkdzdxn) = uqygvldodf vtwxjdtswo (gdtkkereiv )
Positive
06 Nov 2025
Placebo
qlduknishl(cequmxglof) = tnnzgxwkxy nsvwphmpej (hpdrpqthfh )
Phase 3
779
lozqhgklvk(zzmbauxfqe) = npmgqzcgoe mqngvyrlij (apyojethpu )
Negative
01 Nov 2025
lozqhgklvk(zzmbauxfqe) = bscxpzewwo mqngvyrlij (apyojethpu )
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Clinical Trial

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Approval

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Regulation

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