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BMS-986435

Phase 2

Heart Failure | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Jul 13, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment208
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
RECRUITING208 Analytics
PHASE2RECRUITING
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Heart Failure
NCT06122779208
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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 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 Sites117

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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Competitive Landscape -Heart Failure 113 trials

Top 20 of 31 competitors

CompanyTickerTrialsLead PhaseDrugs
Novo Nordisk A/S Sponsored ADR Class BNVO8PHASE3Ziltivekimab
AstraZeneca PLCAZN6PHASE3Undisclosed
Cytokinetics, IncorporatedCYTK2PHASE3Omecamtiv Mecarbil
Amgen Inc.AMGN1PHASE3Maridebart cafraglutide
DexCom, Inc.DXCM1PHASE3Sotagliflozin
Pfizer Inc.PFE1PHASE2Low Dose PF-07328948
Merck & Co., Inc.MRK1PHASE2Vericiguat
Bristol-Myers Squibb CompanyBMY1PHASE2BMS-986435
Novartis AG Sponsored ADRNVS2PHASE1HJB647 low dose
Tectonic Therapeutic IncTECX1PHASE2TX000045- Dose A, TX000045- Dose B
BioCardia, Inc.BCDA2PHASE1CardiALLO Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells
ICON PlcICLR1PHASE2JTT-861
Edwards Lifesciences CorporationEW10N/AUndisclosed
Boston Scientific CorporationBSX4N/AUndisclosed
Medtronic PlcMDT5 - Undisclosed
Abbott LaboratoriesABT8N/AUndisclosed
Colorado Prevention CenterBAYRY1PHASE3Finerenone
Illumina, Inc.ILMN1PHASE218F-metaFluorobenzylguanidine, Rubidium-82
Moderna, Inc.MRNA1 - Undisclosed
CVRx, Inc.CVRX2 - Undisclosed
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Recent Changes (Last 90 Days)
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
LOWMay 26, 2026NCT07226817primaryCompletionDate: changed
LOWMay 26, 2026NCT06122779primaryCompletionDate: changed
LOWMay 26, 2026NCT07248839primaryCompletionDate: changed
LOWMay 24, 2026NCT07226817studyFirstPostDate: changed
LOWMay 24, 2026NCT06122779studyFirstPostDate: changed
LOWMay 24, 2026NCT07248839studyFirstPostDate: changed