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BMS-986231

Phase 2

Cardiac Failure | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Feb 26, 2021

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03730961An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop DiureticPHASE2 COMPLETED 23Jan 17, 2019Jan 9, 2020Feb 26, 20212 United Kingdom
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Study Endpoints
Primary Endpoints
4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo
4 hours

The total volume of urinary output 4 hours after 40 mg furosemide bolus given to participants with HFrEF while on BMS-986231 compared to placebo: absolute difference in total volume and % change from placebo. Sequence 1: Placebo in period 1, drug in period 2 Sequence 2: Drug in period 1, placebo in period 2

Secondary Endpoints
FeNa in Participants With HFrEF While on BMS-986231 Compared to Placebo
Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours
FeK in Participants With HFrEF While on BMS-986231 Compared to Placebo
Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours
Furosemide Urinary Concentrations
Day 1, predose, 0-2 hours, 2-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours, 8-10 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo+Diuretic to BMS-986231+DiureticEXPERIMENTALAdministered in a cross over design with 8-hour continuous infusions and 7-28 day wash-out periods
BMS-986231+Diuretic to Placebo+DiureticEXPERIMENTALAdministered in a cross over design with 8-hour continuous infusions and 7-28 day wash-out periods
Interventions
NameTypeDescription
BMS-986231DRUGIntravenous administration
FurosemideDRUGIntravenous administration
PlaceboDRUGIntravenous administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Left ventricular ejection fraction \<45%, as assessed by echocardiography, a multigated acquisition (MUGA) scan or magnetic resonance imaging (MRI) scan with...

Countries:United Kingdom
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