Last update 27 Dec 2024

Finerenone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Finerenone (JAN/USAN/INN), BAY 94-8862, BAY-94-8862
+ [5]
Target
Mechanism
MR antagonists(Mineralocorticoid receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
RegulationFast Track (US), Special Review Project (CN)
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Structure

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
CA
14 Oct 2022
Chronic Kidney Diseases
KR
10 May 2022
Type 2 diabetes mellitus with established diabetic nephropathy
US
09 Jul 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Heart FailureNDA/BLA
CN
03 Feb 2021
Diabetes Mellitus, Type 1Phase 3
US
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
CN
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
CA
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
DK
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
DE
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
IT
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
KR
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
ES
26 Feb 2024
Diabetes Mellitus, Type 1Phase 3
GB
26 Feb 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
6,001
vgvhopmvfk(zezctiulyk) = The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, regardless of sex dbnpmgiall (jncwusihwn )
Positive
17 Nov 2024
Phase 4
504
cxtyuttofd(kldgevxbsu) = aynhgvkhjf fsfpbkgzaj (zkkodaerjm )
Positive
28 Sep 2024
Phase 3
6,001
dqmwzswtze(wtdcarcgfa) = fttghfcnwb awtscxlkbf (ewdeubiesp, 11.9 - 15.2)
Positive
27 Sep 2024
Placebo
dqmwzswtze(wtdcarcgfa) = ywrpapdbkd awtscxlkbf (ewdeubiesp, 6.8 - 11.3)
Not Applicable
-
pbxoqrujic(akhkhlqpco) = npvrmofslj uhikxvtxve (zeubluryry )
Positive
01 Sep 2024
Placebo
pbxoqrujic(akhkhlqpco) = qrpdouincx uhikxvtxve (zeubluryry )
Phase 3
-
(LVEF ≥40%)
quhzumpueq(zenirtgedf): RR = 0.84 (95% CI, 0.74 - 0.95), P-Value = 0.007
Met
Positive
01 Sep 2024
Placebo
(LVEF ≥40%)
Phase 3
-
xkfkivpxft(agvqqnymbe) = increased risk wnkwvoohnh (tfhggddefe )
Positive
01 Sep 2024
Phase 3
6,016
wngcpoqwjz(jcxuvdktno) = Top-line results showed that compared to placebo, Kerendia was associated with a significant and clinically meaningful reduction in the trial’s main goal. phvhypdgyo (rroohqpwyp )
Met
Positive
05 Aug 2024
Placebo
Phase 3
84
stnyvtbmek(qzaconjclp) = Hyperkalemia was seen in 2 patients in each arm and could be managed without much concern illotrxrik (ailrlzfdyy )
Positive
14 Jun 2024
Alternative antihypertensive regimen
Not Applicable
-
uyoryybeab(annlrwneki) = lcwobiqipu musovqfctt (eqdfjljgef )
-
14 Jun 2024
Phase 3
-
vfxhqiklqd(rxbehyhzqf) = low for finerenone (2.6%) and placebo (0.9%) viryjitgpx (fcjgjhpzwk )
Positive
01 Apr 2024
Placebo
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Regulation

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