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BMS-986259

Phase 2

Acute Decompensated Heart Failure | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Aug 4, 2022

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04318093Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart FailurePHASE2 COMPLETED 25Nov 6, 2020Jul 19, 2021Aug 4, 202218 Argentina, Czechia +4
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Study Endpoints
Primary Endpoints
Percentage of Participants Experiencing Clinically Relevant Hypotension
From first dose to 30 days following first dose

Clinically Relevant Hypotension is defined as occurrence of any of the following: * Supine Systolic Blood Pressure (SBP) \<85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension * Supine SBP \<90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension (eg, dizziness, lightheadedness, etc).

Secondary Endpoints
Maximum Observed Serum Concentration (Cmax)
Day 1 and Day 5 of study treatment
Time of Maximum Observed Serum Concentration (Tmax)
Day 1 and Day 5 of study treatment
Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU))
Day 1 and Day 5 of study treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-986259EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BMS-986259DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Participants currently hospitalized for acute decompensated heart failure (ADHF) * Participants must be hemodynamically stable, as assessed by the investigat...

Countries:ArgentinaCzechiaGreeceIsraelPolandUnited Kingdom
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