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HJB647 low dose

Phase 1

Heart Failure With Reduced Ejection Fraction | Small molecule | Cardiovascular |Novartis AG|Last Updated: Apr 15, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07465653A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection FractionPHASE1 RECRUITING 12Mar 18, 2026Sep 24, 2026Apr 15, 20263 United States
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Study Endpoints
Primary Endpoints
Number of participants with Adverse Events (AEs)
Up to 33 days

Number of participants with AEs as a measure of safety and tolerability

Number of participants with clinically significant changes in vital signs
Up to 33 days

Number of participants with clinically significant changes in Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Electrocardiogram and hyposensitive events as a measure of adverse events

Secondary Endpoints
Pharmacokinetics: Maximum concentration (Cmax)
Up to 7 days
Pharmacokinetics: Time to reach maximum plasma concentration (Tmax)
Up to 7 days
Pharmacokinetics: Area Under the Concentration-Time Curve from dosing form to the last measurable concentration (AUClast)
Up to 7 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORTaken by mouth as capsules
HJB647 low doseEXPERIMENTALTaken by mouth as capsule
HJB647 high doseEXPERIMENTALTaken by mouth as capsule
Interventions
NameTypeDescription
HJB647 low doseDRUGStudy drug low dose in capsule form
HJB647 high doseDRUGStudy drug high dose in capsule form
PlaceboOTHERPlacebo control in capsule form
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: * Men and women aged 18 years or older * Stable NYHA functional class II-III * LVEF \<50% * NT-proBNP ≥600 pg/ml if in sinus rhythm or ≥900 pg/ml if in atrial fibrillation at screening * ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07465653Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07465653studyFirstPostDate: changed