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BMS-986435

Phase 2

Heart Failure | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Trials Updated: Jul 30, 2026

BMS-986435 development status

Highest phase Phase 2
Registered trials 9 across 1 sponsor since Mar 2022

BMS-986435 target and mechanism

ModalitySmall molecule

Also known as MYK-224

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment315

FDA Designations

No designations recorded

BMS-986435 clinical trials

BMS-986435 · 4 trials · 3 indications

Phase 2 1Phase 1 3
NCT06122779Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)Heart Failure
ACTIVE NOT_RECRUITING227 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment emergent adverse events (TEAEs)
Up to approximately 24 weeks
Incidence of serious adverse events (SAEs)
Up to approximately 24 weeks
Incidence of AEs leading to treatment discontinuation
Up to approximately 20 weeks
Maximum observed concentration (Cmax)
Up to 45 days
Time to maximum observed concentration (Tmax)
Up to 45 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Up to 45 days
Maximum observed plasma concentration (Cmax)
Up to 72 days
Time of maximum observed concentration (Tmax)
Up to 72 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Up to 72 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 36 days

Secondary Endpoints

Summary of plasma concentrations of MYK-224
Up to approximately 20 weeks
Metabolite profiling of BMS-986435 in plasma, urine, and feces
Up to 45 days
Number of participants with adverse events (AEs)
Up to 45 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-986435EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
MYK-224EXPERIMENTAL -
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3EXPERIMENTAL -
Arm 4EXPERIMENTAL -
Arm 1: MYK-224EXPERIMENTAL -
Arm 2: MYK-224 + ItraconazoleEXPERIMENTAL -
Arm 3: MYK-224 + VerapamilEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986435DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
MYK-224DRUGSpecified dose on specified days
ItraconazoleDRUGSpecified dose on specified days
VerapamilDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range40 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites86

Inclusion Criteria \- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability. Exclusion Criteria * Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any...

Countries:United StatesArgentinaCanadaChinaIsraelItalyJapanPolandSouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)

MEDIUMJul 30, 2026NCT06122779Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 30, 2026NCT06122779Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about BMS-986435

What is BMS-986435 used for?

BMS-986435 is an investigational small molecule being developed for the treatment of heart failure, specifically heart failure with preserved ejection fraction (HFpEF). It is currently in Phase 2 clinical development and has not been approved for any indication.

Who is developing BMS-986435?

BMS-986435 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the ongoing Phase 2 clinical trial evaluating the drug in patients with heart failure with preserved ejection fraction.

What phase is BMS-986435 in?

BMS-986435 is in Phase 2 clinical development. One Phase 2 trial is currently active and recruiting has closed, with no completed trials reported. The drug remains investigational and has not received regulatory approval for any indication.

What clinical trials is BMS-986435 in?

BMS-986435 is being evaluated in a single Phase 2 trial, NCT06122779, titled a study to evaluate safety, tolerability and drug levels of BMS-986435/MYK-224 in participants with heart failure with preserved ejection fraction. The trial is active but not recruiting, with an enrollment of 227 participants across multiple countries.

Is BMS-986435 the same as MYK-224?

Yes, BMS-986435 is also known as MYK-224. The ongoing Phase 2 trial refers to the drug as BMS-986435/MYK-224, indicating they are the same investigational compound being developed by Bristol-Myers Squibb for heart failure with preserved ejection fraction.

What does BMS-986435 target?

The molecular target of BMS-986435 has not been disclosed. It is a small molecule in Phase 2 development for heart failure with preserved ejection fraction, but no target or mechanism of action information is available.