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Finerenone: intervention A

Phase 1

Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent | Small molecule | Cardiovascular |Bayer AG|Last Updated: Aug 11, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Finerenone: intervention A · 1 trial · 2 indications

Phase 1 1
NCT07116512A Study to Compare How Much of the Study Treatment Finerenone Gets Into the Blood When the Same Amount is Taken in One and in Two Tablets of Different Strengths in Healthy Male ParticipantsHeart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent
COMPLETED60 Analytics
PHASE1COMPLETED
A Study to Compare How Much of the Study Treatment Finerenone Gets Into the Blood When the Same Amount is Taken in One and in Two Tablets of Different Strengths in Healthy Male Participants
Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per CentUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax for plasma finerenone concentration
0-24 h post dose

Cmax: maximum concentration.

AUC(0-tlast) for plasma finerenone concentration
0-24 h post dose

AUC = area under the curve, which was the total amount of finerenone in plasma

Secondary Endpoints

Number of participants with treatment emergent adverse events (TEAEs)
After first administration of study intervention up to 3 days after end of treatment with study intervention
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
finerenone sequences: intervention A_intervention BEXPERIMENTALParticipants received intervention A first, with a washout period of at least 72 hours, participants then received intervention B
finerenone sequences: intervention B_intervention AEXPERIMENTALParticipants received intervention B first, with a washout period of at least 72 hours, participants then received intervention A

Interventions

NameTypeDescription
Finerenone (BAY94-8862): intervention ADRUGStudy intervention A: one tablet of dose strength 1 one tablet of dose strength 1 = two tablets of dose strength 2
Finerenone (BAY94-8862): intervention BDRUGStudy intervention B: two tablets of dose strength 2 two tablets of dose strength 2 = one tablet of dose strength 1
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Participants who were overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, body temperature, vital signs, and E...

Countries:Germany
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Frequently asked questions about Finerenone: intervention A

What is Finerenone used for in Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent?

Finerenone is a small molecule being studied for heart failure with left ventricular ejection fraction greater than or equal to 40 per cent. It is developed by Bayer AG (ticker: BAYRY) and is currently in Phase 1 clinical development as an investigational therapy.

What does Finerenone target?

Finerenone is a small molecule being developed by Bayer AG for cardiovascular conditions. The specific molecular target has not been disclosed in the available clinical trial information, so its mechanism of action is not detailed here.

Who makes Finerenone?

Finerenone is developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is currently in Phase 1 clinical development for heart failure with left ventricular ejection fraction greater than or equal to 40 per cent.

What phase is Finerenone in?

Finerenone is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 60 participants.

What clinical trials is Finerenone in?

Finerenone has one completed clinical trial, NCT07116512, a Phase 1 study in healthy male participants in Germany. The trial compared how much finerenone gets into the blood when the same amount is taken in one versus two tablets of different strengths.

Is Finerenone the same as intervention A?

Finerenone is also referred to as intervention A in clinical trial documentation. The drug is being studied under the name Finerenone, with intervention A serving as an alternative label in the study context.