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florbetaben

Phase 3

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 Enrollment244
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05184088Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL AmyloidosisPHASE3 COMPLETED 244 — — Jan 13, 2023May 5, 2026Jun 2, 202614 United States, Germany +2
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Study Endpoints
Primary Endpoints
Sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis.
Up to 12 weeks

The results from the visual assessment of \[18F\]florbetaben PET images are compared to the clinical diagnosis established through histological verification of the presence or absence of AL amyloidosis with cardiac involvement determined either through endomyocardial biopsy or through extracardiac biopsy in conjunction with typical CMR or echocardiography imaging features as the standard of truth.

Secondary Endpoints
Sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis using quantification.
Up to 12 weeks
Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).
Up to 12 weeks
Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.
Up to 12 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Patients with suspected cardiac amyloidosisEXPERIMENTALAfter enrolment, patients will be subjected to diagnostic procedures according to standard of care to resolve diagnostic uncertainties and to clarify possible cardiac involvement. The results of the clinical work-up will be used a standard of truth, i.e. patients with initially suspected cardiac amyloidosis that where subsequently clinically diagnosed with cardiac AL Amyloidosis, cardiac ATTR Amyloidosis, other cardiac Amyloidosis or non cardiac amyloidosis.
Interventions
NameTypeDescription
[18F]florbetabenDRUGAll enrolled patients will undergo \[18F\]florbetaben PET imaging.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Males and females age ≥18 years * Able to understand, sign and date written informed consent * Written informed consent must be obtained before any study procedures are performed * Subjects being considered for a possible diagnosis of cardiac amyloidosis by * 1\. One of the fo...

Countries:United StatesGermanySpainUnited Kingdom
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Competitive Landscape -Cardiac Amyloidosis 21 trials
CompanyTickerTrialsLead PhaseDrugs
Alnylam Pharmaceuticals, IncALNY5PHASE3Vutrisiran, Sterile Normal Saline, Nucresiran, patisiran
Ionis Pharmaceuticals, Inc.IONS4PHASE3Eplontersen
Novo Nordisk A/S Sponsored ADR Class BNVO4PHASE3NNC6019-0001, Coramitug
AstraZeneca PLCAZN2PHASE3Eplontersen, ALXN2220
Intellia Therapeutics, Inc.NTLA2PHASE3NTLA-2001
Pfizer Inc.PFE2 — Vyndamax
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Recent Changes (Last 90 Days)
HIGHJun 2, 2026NCT05184088Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 2, 2026NCT05184088Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 2, 2026NCT05184088Status: ACTIVE_NOT_RECRUITING → COMPLETED
MEDIUMMay 27, 2026NCT05184088Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMMay 27, 2026NCT05184088Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT05184088primaryCompletionDate: changed
LOWMay 24, 2026NCT05184088studyFirstPostDate: changed