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BMS-986435

Phase 2

Heart Failure | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Aug 12, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment227

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986435 · 5 trials · 4 indications

Phase 2 1Phase 1 4
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 Day 45
Area under the concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
Up to Day 45
Area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)
Up to Day 45
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Up to Day 28
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to Day 28
Maximum observed plasma concentration (Cmax)
Up to 105 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Up to 105 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Up to 105 days
Time of maximum observed concentration (Tmax)
Up to Day 30
Area under the concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Up to Day 30

Secondary Endpoints

Summary of plasma concentrations of MYK-224
Up to approximately 20 weeks
Number of participants with adverse events (AEs)
Up to Day 45
Number of participants with serious adverse events (SAEs)
Up to Day 45
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-986435EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Arm AEXPERIMENTALMild Hepatic Impairment
Arm BEXPERIMENTALModerate Hepatic Impairment
Arm CEXPERIMENTALMatched participants with normal hepatic function
Treatment AEXPERIMENTAL -
Treatment BEXPERIMENTAL -
Treatment CEXPERIMENTAL -
Treatment DEXPERIMENTAL -
Treatment EEXPERIMENTAL -
Treatment FEXPERIMENTAL -
Treatment GEXPERIMENTAL -
Treatment HEXPERIMENTAL -
Treatment IEXPERIMENTAL -
Treatment JEXPERIMENTAL -
Treatment KEXPERIMENTAL -
Treatment LEXPERIMENTAL -
Treatment A: BMS-986435 Reference Dose 1ACTIVE_COMPARATOR -
Treatment B: BMS-986435 Test Dose 1EXPERIMENTAL -
Treatment C: BMS-986435 Test Dose 2EXPERIMENTAL -
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986435DRUGSpecified dose on specified days
PlaceboOTHERSpecified 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)

LOWAug 12, 2026NCT07226817Enrollment: 140 → 240
LOWAug 12, 2026NCT07226817Enrollment: 140 → 240
MEDIUMJul 30, 2026NCT06122779Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 30, 2026NCT06122779Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 13, 2026NCT06122779primaryCompletionDate: changed
MEDIUMJul 13, 2026NCT06122779primaryCompletionDate: changed
MEDIUMJul 2, 2026NCT07226817primaryCompletionDate: changed
MEDIUMJul 2, 2026NCT07226817primaryCompletionDate: changed
MEDIUMJul 2, 2026NCT07226817primaryCompletionDate: changed
MEDIUMJul 2, 2026NCT07226817primaryCompletionDate: changed
MEDIUMJun 12, 2026NCT07248839Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMJun 12, 2026NCT07248839Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about BMS-986435

What is BMS-986435 used for?

BMS-986435 is an investigational small molecule being developed by Bristol-Myers Squibb for heart failure, specifically heart failure with preserved ejection fraction (HFpEF). It is also studied in healthy volunteers to assess safety, tolerability, drug levels, and effects. The drug is currently in clinical development and is not approved by the FDA.

What does BMS-986435 target?

BMS-986435 is a small molecule, but its specific molecular target has not been disclosed in available information. The drug is being evaluated for its effects in heart failure with preserved ejection fraction (HFpEF), but the exact mechanism of action is not publicly detailed.

Who makes BMS-986435?

BMS-986435 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and efficacy in heart failure and healthy volunteer populations.

What phase is BMS-986435 in?

BMS-986435 is in Phase 1 clinical development, with one completed Phase 1 study and two active Phase 1 trials. A Phase 2 study in heart failure with preserved ejection fraction (HFpEF) is also active but not recruiting. The drug remains investigational and has not received FDA approval.

What clinical trials is BMS-986435 in?

BMS-986435 is being studied in several trials, including NCT06122779 (Phase 2 in HFpEF, active not recruiting), NCT06476821 (Phase 1 in healthy Chinese participants, completed), NCT07226817 (Phase 1 bioavailability and food effect study, recruiting), and NCT07248839 (Phase 1 hepatic impairment study, recruiting).

Is BMS-986435 the same as MYK-224?

Yes, BMS-986435 is also known as MYK-224. Clinical trial titles refer to the drug as BMS-986435/MYK-224, indicating that both names refer to the same investigational compound being developed by Bristol-Myers Squibb.