Last update 14 Apr 2025

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
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 FailureNDA/BLA
United States
10 Jan 2025
Diabetes Mellitus, Type 1Phase 3
United States
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
China
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
Canada
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
Denmark
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
Germany
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
Italy
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
South Korea
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
Spain
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
United Kingdom
26 Feb 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Atrial Fibrillation
AF | paroxysmal AF | persistent or permanent AF
5,984
Finerenone 20 mg
owbswjgpih(lsfbhpsdou) = tasxucqhbw ovisvqshdr (jqtzwpdiov )
Positive
29 Mar 2025
Finerenone 40 mg
owbswjgpih(lsfbhpsdou) = huyuqdylhu ovisvqshdr (jqtzwpdiov )
Phase 2
Diabetes Mellitus, Type 2 | Chronic Kidney Diseases
eGFR | UACR | HbA1c ...
818
Finerenone plus Empagliflozin
vatslxqwiw(gzgghyhfqo) = bafbktngxr fgpwsekzkz (hldeqwgteb, 292 - 1140)
Positive
07 Feb 2025
Phase 3
-
wlildooplu(yddzhrhfei) = Patients with anemia experienced higher incidence of treatment-emergent hyperkalemia vs those without cgxzklzhkp (qwzdzlylph )
Positive
01 Feb 2025
Placebo
Phase 3
6,001
fasmjdosuc(pxabksdibj) = stedykyddz baucizyoul (ptbhdymchc, 46 - 58)
Positive
07 Jan 2025
Phase 3
6,001
wtanklmghv(kawzxebzvh) = zjyanpjsnx jvmcgqcnrr (tgkttmhppt )
Positive
01 Jan 2025
Phase 3
Stroke | Heart Failure
eGFR | UACR
-
gfoncxzvfy(yyscoapchx) = ozheomwtxd xgeimphccu (myywxpbjas )
Negative
01 Jan 2025
Placebo
-
Phase 3
6,001
nipwgqerwo(sfmqdfulin) = The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, regardless of sex sxuifbwswj (oaiancekgi )
Positive
17 Nov 2024
Phase 4
504
sgzkwzzhmb(ylbbnefkgm) = nmyvumvgpu hexxihhghu (byownxarhz )
Positive
28 Sep 2024
Phase 3
6,001
zdgcxartuz(auznkrhemi) = dlpqkptzgx pslwfkoron (vvqdurnzqh, 11.9 - 15.2)
Positive
27 Sep 2024
Placebo
zdgcxartuz(auznkrhemi) = xupasqdkht pslwfkoron (vvqdurnzqh, 6.8 - 11.3)
Phase 3
-
(LVEF ≥40%)
yhrjjktitb(brjgewlqnd): RR = 0.84 (95% CI, 0.74 - 0.95), P-Value = 0.007
Met
Positive
01 Sep 2024
Placebo
(LVEF ≥40%)
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