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18F-metaFluorobenzylguanidine

Phase 2

Heart Failure | Small molecule | Cardiovascular |Illumina, Inc.|Last Updated: Mar 27, 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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT0696562118F-mFBG Imaging for Myocardial Sympathetic InnervationPHASE2 NOT YET_RECRUITING 20Apr 28, 2026Dec 30, 2026Mar 27, 20261 United States
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Study Endpoints
Primary Endpoints
Quantify the degree of reduced myocardial 18F-mFBG uptake in adult HF subjects with well-characterized coronary heart disease
24 hours from administration of the study drug for PET imaging and safety follow-up

Obtain computer quantification of global and/or regional differences in myocardial sympathetic innervation (based on 18F-mFBG uptake) between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months

Secondary Endpoints
Quanify regional patterns of 18F-mFBG myocardial uptake and distribution
24 hours from administration of the study drug for PET imaging and safety follow-up
Perform Safety Data Collection for 18F-mFBG
24 hours from administration of the study drug for safety follow-up
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Ischemic cardiomyopathy with ICD dischargeACTIVE_COMPARATOR82Rb and 18F-mFBG will be administered to intraveously to 10 heart failure patients with ischemic cardiomyopathy and an ICD discharge within the past 12 months
Ischemic cardiomyopathy without ICD dischargeACTIVE_COMPARATOR82Rb and 18F-mFBG will be administered intravenously to 10 heart failure patients with ischemic cardiomyopathy and no ICD discharge within the past 12 months
Interventions
NameTypeDescription
18F-metaFluorobenzylguanidineDRUGPET Radiopharmaceutical to assess myocardial sympathetic innervation
Rubidium-82DRUGPET Radiopharmaceutical to assess myocardial perfusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Stable heart failure from ischemic cardiomyopathy, LVEF \< or = 35%, ICD implantation for at least 12 months Exclusion Criteria: * Unstable coronary artery disease, no ICD implantation

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06965621primaryCompletionDate: changed
LOWMay 24, 2026NCT06965621studyFirstPostDate: changed