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BMS-986533

Phase 1

Undisclosed | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Jul 24, 2026

BMS-986533 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment136

FDA Designations

No designations recorded

BMS-986533 clinical trials

BMS-986533 · 1 trial · 1 indication

Phase 1 1
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 ParticipantsHealthy Volunteers
RECRUITING136 Analytics
PHASE1RECRUITING
Single 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 Participants
Healthy Volunteers
NCT07629999136
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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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Recent Changes (Last 90 Days)

LOWJul 24, 2026NCT07629999Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 24, 2026NCT07629999Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about BMS-986533

What is BMS-986533?

BMS-986533 is an investigational small molecule drug being developed by Bristol-Myers Squibb Company (ticker: BMY). It is currently in Phase 1 clinical development, with one active trial evaluating its safety and pharmacokinetics in healthy participants. The specific therapeutic indication for BMS-986533 has not been disclosed.

Who is developing BMS-986533?

BMS-986533 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is the sponsor of the ongoing Phase 1 clinical trial for this investigational small molecule.

What phase is BMS-986533 in?

BMS-986533 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial is currently recruiting participants.

What clinical trials is BMS-986533 in?

BMS-986533 is being studied in one active Phase 1 trial, NCT07629999. This is a single and multiple dose study evaluating safety and pharmacokinetics in healthy participants, along with assessments of food and pH effects on relative bioavailability and drug-drug interaction potential. The trial is recruiting in the United States and has an enrollment of 136 participants.

What does BMS-986533 target?

The molecular target of BMS-986533 has not been disclosed. It is a small molecule drug, but no specific target or mechanism of action information is available.

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