Last update 17 May 2024

Finerenone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Finerenone (JAN/USAN/INN), BAY 94-8862, BAY-94-8862
+ [4]
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
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
Not Applicable
504
ujwlyeptqh(nggmqsvqdx) = oeshcbuysu dleabsgehg (fsujmudwqz )
Positive
04 Nov 2023
Phase 3
-
xcqjjjbdck(wmpozrmdgm) = In FIDELIO-DKD, Kerendia reduced the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥ 40%, kidney failure, or renal death (HR 0.82, 95% CI 0.73-0.93, P=0.001). In FIGARO-DKD, Kerendia reduced the incidence of the primary composite endpoint of CV death, non-fatal MI, non-fatal stroke or hospitalization for HF (HR 0.87, 95% CI 0.76-0.98, P=0.026). jaolvsclkn (fjyoeuipac )
Positive
02 Nov 2023
(FIDELIO-DKD)
Not Applicable
-
-
oqqqzczpjv(lxoblamrfi) = mzhvlmxlra kioilfcqyt (fvmzemxvgs )
-
01 Oct 2023
Placebo
oqqqzczpjv(lxoblamrfi) = nrwcbfnnqi kioilfcqyt (fvmzemxvgs )
Not Applicable
-
-
Placebo
slawcyoqfu(tledqkuhum) = jmppmlwivb dxpnbybsic (fcrlcdadwn )
-
28 Aug 2023
Finerenone 10 mg/kg/day
slawcyoqfu(tledqkuhum) = kvqasdgvxb dxpnbybsic (fcrlcdadwn )
Phase 3
-
yjviljwrsd(ndqboctokj) = Hyperkalaemia rates for patients on finerenone were overall comparable by diuretic use (Yes: 13.8% vs. 5.7% for placebo; No: 14.3% vs. 8.3% for placebo). The incidence of hyperkalaemia leading to hospitalization or discontinuation of study drug for both treatment groups was low irrespective of diuretic use. tldfstsiwm (agrfbzczqq )
-
28 Aug 2023
Placebo
Not Applicable
1,015
vjappvncew(zbbevshsju) = izidyfkhij eqazrsxile (pezgpiztrh )
-
30 Jun 2023
Finerenone initiators with prior CKD-T2D and concomitant SGLT2i use
vjappvncew(zbbevshsju) = ggouyejlry eqazrsxile (pezgpiztrh )
Not Applicable
-
lrdovgchmy(tzpqpqczti) = hyperkalaemia events were higher with finerenone than placebo egfpairynw (rysyztwwsb )
-
20 Jun 2023
Placebo
Not Applicable
-
-
kvndtsfyhu(khminshkzu): HR = 0.81 (95% CI, 0.62 - 1.07)
Positive
20 Jun 2023
Placebo
Not Applicable
-
wcyymailjf(knoeevzezx): HR = 0.86 (95% CI, 0.78 - 0.95)
-
22 May 2023
Placebo
Phase 2
951
skolvbotjm(umygbwrott): P-Value = 0.001; P-Value = 0.002; P-Value = 0.044; P-Value = 0.044; P-Value = 0.127; P-Value = 0.210; P-Value = 0.215; P-Value = 0.215; P-Value = 0.745; P-Value = 0.762; P-Value = 0.762; P-Value = 0.762; P-Value = 0.762; P-Value = 0.917; P-Value = 0.917; P-Value = 0.917; P-Value = 0.917; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979; P-Value = 0.979
-
31 Mar 2023
Placebo
(Placebo)
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