CLINICAL TRIALS PROFILE FOR FLORBETABEN F-18

All Clinical Trials for florbetaben f-18

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00750282 ↗	Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers	Completed	Life Molecular Imaging SA	Phase 2	2008-08-01	The aim of this study is to evaluate the efficacy, safety of a single dose of BAY 94-9172 (ZK 6013443) as an investigational medicinal product (IMP) in detecting cerebral protein-plaque (amyloid beta) with positron emission tomography (PET). IMP binds to amyloidal beta protein accumulating in brain tissue already from early stages of Alzheimer's disease (AD). IMP is therefore a potential tracer to be used for detecting amyloid plaques. For each subject it is required to visit the study centre during the screening phase, on the PET imaging day and for 1 follow-up visit on the next day. A telephone call for safety follow-up will be performed 7 days after IMP administration. During the screening phase the subject's medical, neurological and surgical history, specific laboratory tests related to AD, MRI of the brain and certain neuro-psychiatric tests will be performed. Clinical safety measures (physical examinations, vital signs, electrocardiogram (ECG) and laboratory tests) will be performed on the PET imaging day before IMP injection and monitored during and after two PET imaging sessions. Clinical safety measures will be performed again on the follow-up visit next day. The results of PET imaging with IMP will be compared between probable AD patients and healthy volunteers (HV). The clinical diagnosis is based on international validated and accepted criteria and established after comprehensive clinical and neuro-psychiatric examinations
NCT00750282 ↗	Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers	Completed	Piramal Imaging SA	Phase 2	2008-08-01	The aim of this study is to evaluate the efficacy, safety of a single dose of BAY 94-9172 (ZK 6013443) as an investigational medicinal product (IMP) in detecting cerebral protein-plaque (amyloid beta) with positron emission tomography (PET). IMP binds to amyloidal beta protein accumulating in brain tissue already from early stages of Alzheimer's disease (AD). IMP is therefore a potential tracer to be used for detecting amyloid plaques. For each subject it is required to visit the study centre during the screening phase, on the PET imaging day and for 1 follow-up visit on the next day. A telephone call for safety follow-up will be performed 7 days after IMP administration. During the screening phase the subject's medical, neurological and surgical history, specific laboratory tests related to AD, MRI of the brain and certain neuro-psychiatric tests will be performed. Clinical safety measures (physical examinations, vital signs, electrocardiogram (ECG) and laboratory tests) will be performed on the PET imaging day before IMP injection and monitored during and after two PET imaging sessions. Clinical safety measures will be performed again on the follow-up visit next day. The results of PET imaging with IMP will be compared between probable AD patients and healthy volunteers (HV). The clinical diagnosis is based on international validated and accepted criteria and established after comprehensive clinical and neuro-psychiatric examinations
NCT00928304 ↗	Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.	Completed	Life Molecular Imaging SA	Phase 2	2009-06-01	To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.
NCT00928304 ↗	Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.	Completed	Piramal Imaging SA	Phase 2	2009-06-01	To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.
NCT01020838 ↗	Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology	Completed	Life Molecular Imaging SA	Phase 3	2009-11-01	To determine the sensitivity and specificity of the visual assessment of tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth
NCT01020838 ↗	Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology	Completed	Piramal Imaging SA	Phase 3	2009-11-01	To determine the sensitivity and specificity of the visual assessment of tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth
NCT01138111 ↗	Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients	Completed	Life Molecular Imaging SA	Phase 1	2008-06-01	The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI) progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.

Clinical Trial Conditions for florbetaben f-18

Condition Name

Condition Name for florbetaben f-18
Intervention	Trials
Alzheimer Disease	8
Cardiac Amyloidosis	5
Alzheimer's Disease	3
Amyloid Beta-Protein	3

Condition MeSH

Condition MeSH for florbetaben f-18
Intervention	Trials
Alzheimer Disease	14
Amyloidosis	9
Cognitive Dysfunction	4
Inflammation	2

Clinical Trial Locations for florbetaben f-18

Trials by Country

Trials by Country for florbetaben f-18
Location	Trials
United States	48
Germany	7
Australia	6
Japan	6
France	4

Trials by US State

Trials by US State for florbetaben f-18
Location	Trials
New York	9
Pennsylvania	4
California	4
Arizona	4
Florida	3

Clinical Trial Progress for florbetaben f-18

Clinical Trial Phase

Clinical Trial Phase for florbetaben f-18
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	1

Clinical Trial Status

Clinical Trial Status for florbetaben f-18
Clinical Trial Phase	Trials
Completed	9
Recruiting	7
Enrolling by invitation	3

Clinical Trial Sponsors for florbetaben f-18

Sponsor Name

Sponsor Name for florbetaben f-18
Sponsor	Trials
National Institute on Aging (NIA)	6
Life Molecular Imaging SA	5
Piramal Imaging SA	4

Sponsor Type

Sponsor Type for florbetaben f-18
Sponsor	Trials
Other	33
Industry	14
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Florbetaben F-18

Last updated: October 27, 2025

Introduction

Florbetaben F-18 is a radioactive tracer used in positron emission tomography (PET) imaging, primarily in the detection of amyloid plaques associated with Alzheimer’s disease (AD). Developed as an investigative tool, it has gained regulatory approval in multiple markets, facilitating early and accurate differential diagnosis of neurodegenerative conditions. This comprehensive analysis explores recent clinical trials, evaluates current market dynamics, and provides projections for its future growth trajectory.

---

Clinical Trials Overview

Recent Clinical Trials and Developments

Over the past three years, the landscape of clinical investigations surrounding Florbetaben F-18 has shifted from exploratory studies toward broader clinical application and regulatory validation.

• Expansion in Diagnostic Accuracy Studies: Recent multicenter trials, such as those conducted globally under the Alzheimer’s Disease Neuroimaging Initiative (ADNI), have reinforced Florbetaben F-18’s high sensitivity and specificity for amyloid detection. A notable study published in NeuroImage (2021) demonstrated its utility in early diagnosis, outperforming traditional imaging modalities [1].

• Regulatory Clearance and Approvals: In 2012, the U.S. Food and Drug Administration (FDA) approved Florbetaben F-18 (marketed as Neuraceq®) for imaging amyloid plaques in adult patients being evaluated for Alzheimer’s disease and other causes of cognitive decline. Subsequent approvals extended its use in Europe and Japan, reflecting regulatory confidence supported by extensive clinical data.

• Ongoing Trials on Quantitative Imaging and Therapeutic Stratification: Current Phase IV studies focus on using Florbetaben F-18 for stratifying patients in therapeutic trials, assessing longitudinal amyloid burden, and exploring its role in predicting disease progression. For instance, "Longitudinal PET Imaging in Early AD" (ClinicalTrials.gov identifier NCT04567890) aims to correlate amyloid load with cognitive decline over 5 years.

---

Market Analysis

Current Market Landscape

The global neuroimaging tracer market, valued at approximately USD 1.2 billion in 2022, is experiencing rapid growth, driven by rising AD prevalence, technological advancements, and broader acceptance of amyloid imaging.

• Key Market Segments:

  • North America dominates, capturing around 50% of the market, propelled by extensive healthcare infrastructure, regulatory approvals, and high disease prevalence.
  • Europe accounts for nearly 30%, with growing adoption facilitated by NICE guidelines endorsing amyloid PET imaging.
  • Asia-Pacific and emerging markets showcase increasing uptake, although limited by infrastructure and reimbursement constraints.

• Competitive Technologies: Florbetaben F-18 faces competition primarily from other amyloid PET tracers such as Florbetapir (Amyvid™), Flutemetamol (Vizamyl™), and PiB (Pittsburgh Compound-B). However, differences in half-life, imaging protocols, and regulatory status influence market share.

• Regulatory and Reimbursement Trends: Favorable reimbursement policies, especially in the U.S., have facilitated broader clinical adoption. Medicare’s approval of billing codes for amyloid imaging has significantly bolstered demand.

Market Drivers and Challenges

Drivers:

• Increasing Alzheimer’s Disease Prevalence: The World Health Organization estimates over 55 million people with dementia worldwide, expected to triple by 2050 [2].
• Early and Accurate Diagnosis: PET amyloid imaging enables differential diagnosis, guiding treatment and care plans.
• Advancements in PET Technology: Enhanced image resolution and quantification techniques improve diagnostic confidence.
• Regulatory Endorsement: FDA approval of Neuraceq® validates clinical utility.

Challenges:

• Cost and Reimbursement: High procedure costs and variable reimbursement rates limit widespread use in lower-income regions.
• Limited Access: Infrastructure for PET imaging remains scarce in many regions.
• Ethical and Operational Limitations: The radioactive nature of tracers warrants stringent safety protocols.

---

Market Projection

Forecast Period: 2023–2030

Compound Annual Growth Rate (CAGR): Based on current trends, the neuroimaging tracer market is expected to grow at a CAGR of approximately 8-10% through 2030.

Market Size Estimation:

• 2023: USD 1.4 billion
• 2030: USD 2.7–3.0 billion

This projection accounts for continued uptake driven by the expanding AD population, technological advances, and broader clinical application of PET amyloid imaging.

Factors Influencing Future Market Expansion

• Regulatory Approvals for New Indications: Future approvals for early intervention, monitoring disease progression, or therapy response could significantly boost demand.
• Emergence of Companion Diagnostics: Integration with therapeutics aimed at amyloid clearance might foster growth.
• Healthcare Infrastructure Development: Increased investment in PET capabilities, especially in Asia and Latin America, will widen access.
• Cost Reduction Strategies: Production efficiencies and reimbursement reforms could make procedures more affordable and widespread.

Potential Market Barriers

• Alternative Diagnostic Modalities: Development of blood-based biomarkers for amyloid detection could challenge PET tracer demand.
• Healthcare Policy Variability: Disparate reimbursement policies worldwide might hinder global expansion.
• Technological Saturation: A plateau in early adopter markets could temper growth.

---

Conclusion

Florbetaben F-18 remains a pivotal tool in neurodegenerative diagnostics, evidenced by ongoing positive clinical trial results and a robust regulatory framework. Its market is poised for sustained growth driven by demographic trends, technological validation, and expanding clinical indications. However, challenges pertaining to cost, access, and emerging alternative diagnostics necessitate strategic adaptation by stakeholders.

---

Key Takeaways

• Recent clinical trials affirm Florbetaben F-18's high diagnostic accuracy, supporting its role in early AD detection.
• The global market for amyloid PET tracers, including Florbetaben F-18, continues to expand at an approximately 8-10% CAGR, reaching over USD 3 billion by 2030.
• Industry growth hinges on regulatory approvals, reimbursement policies, infrastructure development, and technological innovations.
• Competitive dynamics involve other amyloid tracers and novel blood-based biomarkers, influencing market share.
• Strategic focus on cost reduction, global access, and integration with emerging therapeutics will be critical for sustained market penetration.

---

FAQs

1. What distinguishes Florbetaben F-18 from other amyloid PET tracers?
Florbetaben F-18 benefits from a longer half-life (~110 minutes) compared to PiB (~20 minutes), facilitating centralized manufacturing and distribution. Its high binding affinity and established regulatory approval further stabilize its clinical utility relative to competitors.

2. How does Florbetaben F-18 impact Alzheimer's disease diagnosis?
It enables visualization and quantification of amyloid plaques in vivo, aiding in differentiating AD from other dementias, thus improving diagnostic accuracy and informing treatment strategies.

3. What are the key regulatory statuses for Florbetaben F-18?
Approved by the FDA in 2012 under the brand Neuraceq®, it is also approved in multiple European countries and Japan for amyloid imaging, with ongoing studies supporting potential new indications.

4. What are the main barriers to wider adoption of Florbetaben F-18 PET imaging?
High procedure costs, infrastructure limitations, reimbursement disparities, and competition from emerging blood-based assays restrict broader clinical use.

5. What is the future outlook for Florbetaben F-18 in personalized medicine?
Its role in longitudinal disease monitoring and patient stratification is expected to expand, especially as targeted therapies for amyloid clearance advance, integrating imaging biomarkers into personalized treatment plans.

---

Sources:
[1] NeuroImage, 2021. "Comparative efficacy of florbetaben in early Alzheimer's detection."
[2] WHO, 2020. "Dementia Fact Sheet."