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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

Target and mechanism

ModalitySmall molecule

Also known as Finerenone (BAY94-8862): intervention A

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: intervention A?

Finerenone: intervention A is an investigational small molecule developed by Bayer AG for heart failure with left ventricular ejection fraction greater than or equal to 40 per cent. It has been studied in a Phase 1 clinical trial in healthy male volunteers in Germany. It is not described as approved and remains in clinical development.

What is Finerenone: intervention A used for in heart failure with left ventricular ejection fraction greater than or equal to 40 per cent?

Finerenone: intervention A is being studied for heart failure with left ventricular ejection fraction greater than or equal to 40 per cent, a cardiovascular condition. The completed Phase 1 trial enrolled healthy male volunteers rather than patients with this condition, so the study examined drug exposure rather than clinical benefit in heart failure.

Who makes Finerenone: intervention A?

Finerenone: intervention A is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the Phase 1 trial of the asset. The drug is a small molecule in the cardiovascular therapeutic area.

What phase is Finerenone: intervention A in?

Finerenone: intervention A is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials of the asset are currently active. It is investigational and has not been described as approved for any indication.

What clinical trials is Finerenone: intervention A in?

Finerenone: intervention A has been studied in one completed Phase 1 trial, NCT07116512, titled a study comparing how much of the study treatment gets into the blood when the same amount is taken in one and in two tablets of different strengths. It enrolled 60 healthy male participants aged 18 years and older in Germany.

Is Finerenone: intervention A the same as Finerenone (BAY94-8862): intervention A?

Yes, Finerenone: intervention A is also known as Finerenone (BAY94-8862): intervention A. Both names refer to the same Bayer small molecule studied in the Phase 1 trial NCT07116512 for heart failure with left ventricular ejection fraction greater than or equal to 40 per cent.