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BMS-986435

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Mar 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials3
Total Enrollment184
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07248839A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Different Degrees of Hepatic ImpairmentPHASE1 NOT YET_RECRUITING 24 — — Dec 15, 2025Apr 6, 2026Nov 25, 2025 - —
NCT07226817A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult ParticipantsPHASE1 RECRUITING 140 — — Nov 12, 2025Jul 1, 2026Mar 4, 20261 United States
NCT06476821A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese ParticipantsPHASE1 COMPLETED 20 — — Jun 27, 2024Oct 11, 2024Nov 19, 20241 China
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Study Endpoints
Primary Endpoints
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
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
Number of participants with adverse events (AEs)
Up to Day 45
Number of participants with serious adverse events (SAEs)
Up to Day 45
Time of maximum observed concentration (Tmax)
Up to Day 45
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
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 -
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986435DRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Participant must have documented LVEF ≥ 60% (2D biplane Simpson's Method) and absence of cardiac abnormality. * Participant must have body weight of \> 50 kg and BMI of 18.0 kg/m2 through 40 kg/m2, inclusive, at screening. * Participants must have adequate renal function at sc...

Countries:United StatesChina
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07226817primaryCompletionDate: changed
LOWMay 26, 2026NCT07248839primaryCompletionDate: changed
LOWMay 24, 2026NCT07226817studyFirstPostDate: changed
LOWMay 24, 2026NCT07248839studyFirstPostDate: changed