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Florbetaben F18

Phase 1FDA approved

Cardiac Amyloidosis | Small molecule | Other |Lantheus Holdings, Inc.|Trials Updated: Aug 3, 2026

Florbetaben F18 development status

FDA approval on record Mar 19, 2014 as Neuraceq
Approval holderLantheus
ApplicationNDA204677
Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2025

Label indication NEURACEQ is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products NEURACEQ is a radioactive… FDA label

Florbetaben F18 target and mechanism

Molecular targetbeta-amyloid
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Florbetaben F18 clinical trials

Florbetaben F18 · 1 trial · 1 indication

Phase 1 1
NCT06790394Test-retest Study With [18F]FBB in Cardiac AmyloidosisCardiac Amyloidosis
RECRUITING15 Analytics
PHASE1RECRUITING
Test-retest Study With [18F]FBB in Cardiac Amyloidosis
Cardiac AmyloidosisUnlock trial analytics

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 to 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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Competitive Landscape -Cardiac Amyloidosis 20 trials

Recent Changes (Last 90 Days)

LOWAug 3, 2026NCT06790394lastUpdatePostDate: changed

Frequently asked questions about Florbetaben F18

What is Florbetaben F18 used for in Cardiac Amyloidosis?

Florbetaben F18 is an investigational small molecule being studied for use in Cardiac Amyloidosis, a condition where abnormal protein deposits accumulate in the heart. It is a radioactive diagnostic agent that binds to beta-amyloid deposits, potentially allowing visualization of cardiac amyloidosis through imaging. The drug is currently in Phase 1 clinical development.

What does Florbetaben F18 target?

Florbetaben F18 targets beta-amyloid, a protein that forms abnormal deposits in tissues. In Cardiac Amyloidosis, these deposits can accumulate in the heart muscle. By binding to beta-amyloid, Florbetaben F18 may enable detection of amyloid deposits through positron emission tomography (PET) imaging, helping to diagnose or monitor the condition.

Who makes Florbetaben F18?

Florbetaben F18 is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker symbol LNTH. The company is conducting clinical research to evaluate the drug's potential as a diagnostic imaging agent for Cardiac Amyloidosis.

What phase is Florbetaben F18 in?

Florbetaben F18 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study is currently recruiting participants to evaluate the drug's properties in patients with Cardiac Amyloidosis.

What clinical trials is Florbetaben F18 in?

Florbetaben F18 is being studied in a Phase 1 clinical trial with the identifier NCT06790394, titled "Test-retest Study With [18F]FBB in Cardiac Amyloidosis." This single-center study in the United Kingdom is recruiting 15 participants aged 40 years and older with Cardiac Amyloidosis. The trial is uncontrolled and not randomized or blinded.