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Florbetaben F18

Phase 1

Cardiac Amyloidosis | Small molecule | Other |Lantheus Holdings, Inc.|Last Updated: Jun 2, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06790394Test-retest Study With [18F]FBB in Cardiac AmyloidosisPHASE1 RECRUITING 15Oct 21, 2025Sep 1, 2026Jun 2, 20262 United Kingdom
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Study Endpoints
Primary Endpoints
Test-Retest variability of cardiac [18F]florbetaben PET uptake
The duration of the study for participants may be up to 73 days.

Percent Test-Retest variability (%) of cardiac 18F florbetaben PET

Secondary Endpoints
Test-Retest variability of extracardiac [18F]florbetaben uptake
The duration of the study for participants may be up to 73 days.
Net influx rate derived from full tracer kinetic modelling
The duration of the study for participants may be up to 73 days.
Volume of distribution derived from full tracer kinetic modelling
The duration of the study for participants may be up to 73 days.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Patients with cardiac diseaseEXPERIMENTALAll eligible AL, ATTR and non-CA patients will receive two injections of the investigational imaging agent florbetaben: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 5 patients of each group will be required.
Interventions
NameTypeDescription
Florbetaben F18DRUGFlorbetaben F18 is a radioactive diagnostic agent being developed for the indication of PET imaging of the heart to detect amyloid pathology. All patients will receive two administrations of Florbetaben F18 at a radioactive dose of 300 megabecquerel (MBq).
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Inclusion criteria (for all subjects): * Males and females aged ≥40 years * Able to understand, sign, and date written informed consent * Written informed consent must be obtained before any assessment is performed * Female subjects must be documented by medical recor...

Countries:United Kingdom
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT06790394lastUpdatePostDate: changed
LOWJun 2, 2026NCT06790394lastUpdatePostDate: changed
LOWJun 2, 2026NCT06790394lastUpdatePostDate: changed
LOWMay 26, 2026NCT06790394primaryCompletionDate: changed
LOWMay 24, 2026NCT06790394studyFirstPostDate: changed