Recent Updates
Recently added Catalysts

BMS-986533

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment118
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07629999Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy ParticipantsPHASE1 NOT YET_RECRUITING 118 — — Jun 30, 2026Jun 1, 2027Jun 5, 20261 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of participants with Adverse Events (AE)
Up to Day 47
Number of participants with Serious Adverse Events (SAE)
Up to Day 47
Number of participants with Vital Sign Abnormalities
Up to Day 27
Number of participants with Physical Examination Abnormalities
Up to Day 27

Including neurological examination

Number of participants with Electrocardiogram (ECG) Abnormalities
Up to Day 27
Number of participants with Clinical Laboratory Assessments Abnormalities
Up to Day 27
Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Up to Day 27
Secondary Endpoints
Maximum observed concentration (Cmax)
Up to Day 26 from last dose
Time of maximum observed concentration (Tmax)
Up to Day 26 from last dose
Area under the concentration-time curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
Up to Day 26 from last dose
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -
Arm CEXPERIMENTAL -
Arm DEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986533DRUGSpecified dose on specified days
FamotidineDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
Dabigatran EtexilateDRUGSpecified dose on specified days
RosuvastatinDRUGSpecified dose on specified days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants must have a body mass index (BMI) of 18 to 32.44 kg/m2, inclusive, and total body weight ≥ 50 kg. * Female (as assigned at birth) participants who are not of childbearing potential must have documented proof of reproductive status. * A male (as assigned at birth) ...

Countries:United States
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT07629999NEW_TRIAL: changed
LOWJun 5, 2026NCT07629999NEW_TRIAL: changed
LOWJun 5, 2026NCT07629999NEW_TRIAL: changed
LOWJun 5, 2026NCT07629999NEW_TRIAL: changed