BMS-986460

Recently added Catalysts

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jan 20, 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

RandomizedCONTROLLEDDMCBiomarker

Total Trials1

Total Enrollment85

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT06877702	A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants	PHASE1	COMPLETED	85	—	—	Mar 19, 2025	Dec 17, 2025	Jan 20, 2026	1	United States

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Study Endpoints

Primary Endpoints

Part 1: Number of Participants With Adverse Events (AEs)

Up to approximately Day 43

Part 1: Number of Participants With Serious AEs (SAEs)

Up to approximately Day 43

Part 1: Number of Participants With Clinically Significant Physical Evaluation (PE) Findings

Up to approximately Day 21

Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities

Up to approximately Day 21

Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

Up to approximately Day 21

Part 1: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings

Up to approximately Day 21

Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986460

Up to approximately Day 21

Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986460

Up to approximately Day 21

Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986460

Up to approximately Day 21

Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986460

Up to approximately Day 21

Part 1: Relative Bioavailability (rBA) of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on Geometric Mean Ratio (GMR) of Cmax

Up to approximately Day 21

Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(0-T)

Up to approximately Day 21

Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(INF)

Up to approximately Day 21

Part 2: Number of Participants With AEs

Up to approximately Day 29

Part 2: Number of Participants With SAEs

Up to approximately Day 29

Part 2: Number of Participants With Clinically Significant PE Findings

Up to approximately Day 7

Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities

Up to approximately Day 7

Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

Up to approximately Day 7

Part 2: Number of Participants With Clinically Significant 12-lead ECG Findings

Up to approximately Day 7

Part 2: Cmax of BMS-986460

Up to approximately Day 7

Part 2: Tmax of BMS-986460

Up to approximately Day 7

Part 2: AUC [0-T] of BMS-986460

Up to approximately Day 7

Part 2: AUC(INF) of BMS-986460

Up to approximately Day 7

Secondary Endpoints

Part 2: Pharmacokinetic (PK) Linearity of BMS-986460 Based on Cmax

Up to approximately Day 7

Part 2: PK Linearity of BMS-986460 Based on AUC(0-T)

Up to approximately Day 7

Part 2: PK Linearity of BMS-986460 Based on AUC(INF)

Up to approximately Day 7

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Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelCROSSOVER

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Part 1: Sequence 1	EXPERIMENTAL	-
Part 1: Sequence 2	EXPERIMENTAL	-
Part 1: Sequence 3	EXPERIMENTAL	-
Part 2: Treatment A	EXPERIMENTAL	-
Part 2: Treatment B	EXPERIMENTAL	-
Part 2: Optional Treatment C	EXPERIMENTAL	-
Part 2: Optional Treatment D	EXPERIMENTAL	-
Part 2: Optional Treatment E	EXPERIMENTAL	-

Interventions

Name	Type	Description
BMS-986460	DRUG	Specified dose on specified days.

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Eligibility Criteria

Age Range18 Years — 60 Years

SexMALE

Healthy VolunteersYes

Study Sites1

Inclusion Criteria * Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, echocardiogram or clinical laboratory assessments, as determined by the investigator. * Participants must have a Bo...

Countries:United States

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Recently added Catalysts

BMS-986460

Success Probability

Market & Valuation

Trial Design

FDA Designations

Clinical Trials (1)

Study Endpoints

Primary Endpoints

Secondary Endpoints

Study Design & Arms

Treatment Arms

Interventions

Eligibility Criteria