Recent Updates
Recently added Catalysts

BMS-985521

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jan 7, 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 Enrollment106
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07283263A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.PHASE1 RECRUITING 106Dec 23, 2025Nov 17, 2026Jan 7, 20261 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
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
Maximum Concentration (Cmax) of BMS-986521 in Plasma
Up to approximately Day 14
Time to Cmax (Tmax) of BMS-986521 in Plasma
Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero to the Last Measured Time Point (AUC(0-T)) of BMS-986521 in Plasma
Up to approximately Day 14
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
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-985521DRUGSpecified dose on specified days.
PlaceboOTHERSpecified dose on specified days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests. * Participants must have a body mass index (BMI) between 18 and 32 kg/m²...

Countries:United States
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07283263primaryCompletionDate: changed
LOWMay 24, 2026NCT07283263studyFirstPostDate: changed