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BMS-986521

Phase 1

Undisclosed | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Jul 10, 2026

BMS-986521 development status

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

BMS-986521 target and mechanism

ModalitySmall molecule

Also known as BMS-985521

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment118

FDA Designations

No designations recorded

BMS-986521 clinical trials

BMS-986521 · 2 trials · 1 indication

Phase 1 2
NCT07655518A Positron Emission Tomography Study to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult ParticipantsHealthy Volunteers
RECRUITING12 Analytics
NCT07283263A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.Healthy Volunteers
RECRUITING106 Analytics
PHASE1RECRUITING
A Positron Emission Tomography Study to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants
Healthy VolunteersUnlock trial analytics
PHASE1RECRUITING
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage occupancy of M4 receptor in the brain
Up to approximately 28 hours after last dose

Based on PET scans

Number of participants with treatment-emergent adverse events (AEs)
Up to approximately Day 40
Number of participants with treatment-emergent serious adverse events (SAEs)
Up to approximately Day 40
Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Up to approximately Day 14

Secondary Endpoints

Number of participants with treatment-emergent AEs (TEAEs)
Up to Day 38
Number of participants with treatment-emergent serious AEs (SAEs)
Up to Day 38
Number of participants with treatment-emergent suicidal ideation and behavior
Up to Day 11
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-986521: Cohort 1EXPERIMENTAL -
BMS-986521: Cohort 2EXPERIMENTAL -
BMS-986521: Cohort 3EXPERIMENTAL -
Part A Cohort 1EXPERIMENTAL -
Part A Cohort 2EXPERIMENTAL -
Part A Cohort 3EXPERIMENTAL -
Part A Cohort 4EXPERIMENTAL -
Part A Cohort 5EXPERIMENTAL -
Part A Cohort 6EXPERIMENTAL -
Part B Cohort 7EXPERIMENTAL -
Part B Cohort 8EXPERIMENTAL -
Part B Cohort 9EXPERIMENTAL -
Part B Cohort 10EXPERIMENTAL -
Part B Cohort 11EXPERIMENTAL -
Part CEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986521DRUGSpecified dose on specified days
BMS-985521DRUGSpecified dose on specified days.
PlaceboOTHERSpecified 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 be healthy male and female (as assigned at birth) who are individuals not of childbearing potential (INOCBP) without clinically significant deviation from normal in medical history, PE, 12-lead ECG, and clinical laboratory assessments. * Participants must hav...

Countries:BelgiumUnited States
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Frequently asked questions about BMS-986521

What is BMS-986521?

BMS-986521 is an investigational small molecule being developed by Bristol-Myers Squibb Company. It is in Phase 1 clinical development, with two active trials currently recruiting healthy adult participants. No patient indication has been disclosed for the program.

What does BMS-986521 target?

BMS-986521 targets the M4 muscarinic acetylcholine receptor. One Phase 1 positron emission tomography study is designed to assess occupancy of M4 muscarinic acetylcholine receptors by BMS-986521 in healthy adult participants, which indicates the receptor is the intended molecular target of the compound.

Who makes BMS-986521?

Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, is developing BMS-986521. The company is the sponsor of both Phase 1 trials of the small molecule that are currently listed as recruiting.

What phase is BMS-986521 in?

BMS-986521 is in Phase 1 clinical development. It is an investigational small molecule and is not approved for any use. Two Phase 1 trials are active and recruiting, and no trials for the program have been completed.

What clinical trials is BMS-986521 in?

BMS-986521 is being studied in two recruiting Phase 1 trials. NCT07655518 is a positron emission tomography study assessing M4 muscarinic acetylcholine receptor occupancy in healthy adults in Belgium. NCT07283263 evaluates safety, tolerability, and drug levels in healthy participants in the United States.

Is BMS-986521 the same as BMS-985521?

Yes, BMS-985521 is an alternative name for BMS-986521. Both names refer to the same investigational small molecule from Bristol-Myers Squibb Company, so searches using either designation point to the same Phase 1 development program.