CLINICAL TRIALS PROFILE FOR FLORBETAPIR F-18

All Clinical Trials for FLORBETAPIR F-18

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00702143 ↗	A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)	Completed	Avid Radiopharmaceuticals	Phase 2	2008-06-01	Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).
NCT00857415 ↗	Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain	Completed	Avid Radiopharmaceuticals	Phase 3	2008-12-01	The study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid by dissection of the brain at autopsy. Amyloid in the brain is a key feature of Alzheimer's Disease (AD).
NCT00857506 ↗	Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)	Completed	Avid Radiopharmaceuticals	Phase 2	2009-01-01	The primary objective of this protocol is to determine if brain amyloid imaged with florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and Alzheimer's disease. Hypothesis 1: The probability a subject will experience progressive cognitive impairment within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated amyloid positive compared to subjects whose PET scan was rated amyloid negative. The secondary objective is to determine the stability, over 36 months of a clinical diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET. Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated as amyloid positive.
NCT00857532 ↗	Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2009-01-01	The primary aim of this study is to compare regional amyloid burden in Parkinson's disease (PD) to normal control subjects. We hypothesize that there will be significant differences in overall amyloid burden in PD patients compared to age-matched normal controls.
NCT00857532 ↗	Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients	Completed	National Institutes of Health (NIH)	Phase 2	2009-01-01	The primary aim of this study is to compare regional amyloid burden in Parkinson's disease (PD) to normal control subjects. We hypothesize that there will be significant differences in overall amyloid burden in PD patients compared to age-matched normal controls.
NCT00857532 ↗	Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients	Completed	Avid Radiopharmaceuticals	Phase 2	2009-01-01	The primary aim of this study is to compare regional amyloid burden in Parkinson's disease (PD) to normal control subjects. We hypothesize that there will be significant differences in overall amyloid burden in PD patients compared to age-matched normal controls.
NCT01383161 ↗	18-Month Study of Memory Effects of Curcumin	Completed	University of California, Los Angeles	Phase 2	2012-03-01	This project is designed to study the effects of the dietary supplement curcumin on age-related cognitive impairment. In particular, the study seeks to determine the effects of curcumin on cognitive decline and the amount of abnormal amyloid protein in the brain. Genetic risk will also be studied as a potential predictor of cognitive decline. Subjects will be randomly assigned to one of two treatment groups: either a placebo twice daily or the curcumin supplement (Theracurmin®, containing 90 mg of curcumin). The investigators expect that the volunteers receiving the curcumin supplement will show less evidence of decline after 18 months than those receiving the placebo. The investigators predict that cognitive decline and treatment response will vary according to genetic risk for Alzheimer's. The investigators will study subjects with memory complaints aged 50-90 years. Initially, subjects will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to rule out other neurodegenerative disorders linked to memory complaints. Subsequently, subjects will undergo an -(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2-naphthyl}ethylidene)malononitrile (FDDNP) PET scan and a baseline neuropsychological assessment to confirm a diagnosis of MCI or normal aging. Once enrolled, subjects will begin taking the supplement (either curcumin or a placebo). Some of the initial subjects will be asked to return every three months for regular MRIs. Every 6 months, subjects will also receive neuropsychological assessments. At the conclusion of the study, subjects will be asked to complete a final neuropsychological assessment, MRI scan, PET scan and blood draw. Additional blood will be drawn at baseline and at 18 months and frozen to assess inflammatory markers if cognitive outcomes are positive. FDDNP-PET scans will be used to measure the amount of abnormal amyloid plaque- and tau tangle-proteins in the brain; the MRIs will be used to monitor supplement side effects and measure brain structure; the neuropsychological assessments will monitor rates of cognitive decline; the blood draws will be used to determine genetic risk and to test levels of inflammatory markers.

Clinical Trial Conditions for FLORBETAPIR F-18

Condition Name

Condition Name for FLORBETAPIR F-18
Intervention	Trials
Alzheimer's Disease	19
Alzheimer Disease	12
Mild Cognitive Impairment	7
Parkinson's Disease	3

Condition MeSH

Condition MeSH for FLORBETAPIR F-18
Intervention	Trials
Alzheimer Disease	34
Cognitive Dysfunction	14
Cognition Disorders	9
Mild Cognitive Impairment	8

Clinical Trial Locations for FLORBETAPIR F-18

Trials by Country

Trials by Country for FLORBETAPIR F-18
Location	Trials
United States	140
Australia	7
Canada	6
Italy	5
Spain	5

Trials by US State

Trials by US State for FLORBETAPIR F-18
Location	Trials
California	12
New York	11
Florida	11
Arizona	11
Pennsylvania	8

Clinical Trial Progress for FLORBETAPIR F-18

Clinical Trial Phase

Clinical Trial Phase for FLORBETAPIR F-18
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	9
Phase 3	6

Clinical Trial Status

Clinical Trial Status for FLORBETAPIR F-18
Clinical Trial Phase	Trials
Completed	32
Recruiting	7
Not yet recruiting	3

Clinical Trial Sponsors for FLORBETAPIR F-18

Sponsor Name

Sponsor Name for FLORBETAPIR F-18
Sponsor	Trials
Avid Radiopharmaceuticals	27
Eli Lilly and Company	3
National Institute on Aging (NIA)	3

Sponsor Type

Sponsor Type for FLORBETAPIR F-18
Sponsor	Trials
Industry	38
Other	29
NIH	6

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

Last updated: October 30, 2025

Introduction

Florbetapir F-18 (marketed as Amyvid) is a radioactive diagnostic agent used in positron emission tomography (PET) imaging to assess amyloid plaque density in the brain, aiding in the diagnosis of Alzheimer’s disease (AD). Since its FDA approval in 2012, Florbetapir F-18 has established a critical role in neurodegenerative disease diagnostics. Understanding its clinical development trajectory, market dynamics, and future projections is vital for stakeholders invested in neuroimaging and Alzheimer’s therapeutics.

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Clinical Trials Update

Regulatory Approval and Clinical Adoption

Since its FDA approval, Florbetapir F-18 has undergone extensive post-approval studies to enhance diagnostic accuracy, optimize imaging protocols, and validate its clinical utility. The agent’s core approval was based primarily on phase III clinical trials demonstrating its sensitivity and specificity for amyloid pathology in vivo.

Recent developments have focused on expanding its indication, integrating with emerging biomarkers, and exploring its use in early detection of preclinical Alzheimer’s stages. For example, ongoing studies aim to establish its utility in differentiating amyloid-positive from amyloid-negative patients with mild cognitive impairment (MCI), a crucial factor in clinical trial enrollment for disease-modifying therapies.

Recent Clinical Trials and Research

As of 2023, several pivotal and observational studies have further validated Florbetapir F-18’s diagnostic accuracy:

• Nielsen et al. (2021) conducted a multicenter cohort study showing that Florbetapir PET imaging correlates strongly with post-mortem amyloid plaque burden, reinforcing its role as a reliable biomarker for amyloid pathology in vivo [1].

• The ADNI (Alzheimer’s Disease Neuroimaging Initiative) ongoing research incorporates Florbetapir F-18 in longitudinal studies tracking amyloid accumulation, with preliminary data suggesting its effectiveness in predicting progression from MCI to Alzheimer’s dementia.

• Emerging studies are investigating combined modality imaging—integrating Florbetapir PET with tau PET scans—to improve diagnostic precision in early-stage Alzheimer’s disease, which could influence future clinical trial protocols.

Pipeline and Next-Generation Agents

While Florbetapir F-18 remains the most widely used amyloid imaging agent, research is advancing toward next-generation tracers with improved half-life, higher binding affinity, and lower non-specific binding. Agents such as Florbetaben and Flutemetamol are also in various stages of approval and clinical validation, potentially offering competitive alternatives.

Key regulatory developments include the submission of supplemental new drug applications (sNDAs) by manufacturers aiming to expand indications and refine dosing strategies, which will impact clinical utilization patterns.

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Market Analysis

Market Landscape and Key Players

Florbetapir F-18 operates within the specialized neuroimaging market, primarily serving hospitals, radiology centers, and research institutions. The primary manufacturer, Lantheus Holdings, Inc., holds the market dominance, with the product available in over 25 countries.

Emerging competitors include Fujifilm, with their F-18 amyloid tracers, and academic partnerships developing novel agents for amyloid imaging, which could challenge Florbetapir’s market share.

Market Drivers

• Rising burden of Alzheimer’s disease: The global prevalence is projected to reach 131 million by 2050, emphasizing the demand for accurate early diagnosis tools [2].

• Regulatory acceptance and reimbursement: Increased insurance reimbursement for amyloid PET scans in the U.S. and Europe boosts adoption among neurologists and specialists.

• Increased clinical utility: Integration of amyloid imaging into diagnostic criteria for MCI and early AD aligns with personalized medicine approaches.

• Research and clinical trial use: Pharmaceutical companies conducting anti-amyloid and disease-modifying trials rely on Florbetapir PET imaging for patient stratification and efficacy monitoring.

Market Size and Revenue

The global neuroimaging tracers market was valued at approximately $450 million in 2022, with amyloid PET tracers accounting for roughly 60% of this segment [3]. Florbetapir F-18 commands a substantial share, with revenues estimated at $200 million globally in 2022.

Market Challenges

• High costs and limited accessibility: PET imaging remains expensive and limit access predominantly to tertiary centers.

• Alternatives and competing agents: As newer tracers with longer half-lives and lower production costs emerge, Florbetapir faces competitive pressure.

• Limited indication expansion: Currently approved primarily for diagnostic aid, with limited label expansion to other neurodegenerative diseases.

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Market Projections

Future Demand and Growth Outlook

Analysts project a compound annual growth rate (CAGR) of approximately 8-10% for the amyloid PET agents market through 2030, driven by increased adoption, expanded clinical indications, and ongoing research activities. The anticipated growth aligns with the global shift toward early diagnosis and precision medicine in neurodegenerative diseases.

Potential Drivers of Growth

• Expansion of indications: Future approvals for use in preclinical populations or as a companion diagnostic for amyloid-targeting therapies could significantly expand market reach.

• Integration into routine clinical practice: As awareness grows and reimbursement expands, amyloid PET imaging will become a standard component in diagnostic algorithms for dementia.

• Advancements in imaging technology: Newer tracers and hybrid imaging modalities (such as PET/MRI) offer improved diagnostic capabilities, boosting overall demand.

Risks and Market Constraints

• Emerging competitors: Next-generation tracers with favorable pharmacokinetics could threaten Florbetapir’s market dominance.

• Regulatory barriers: Delays or restrictions around expanding indications or reimbursement policies could dampen growth.

• Cost-effectiveness concerns: Payer hesitations about the economic burden of widespread PET imaging in early-stage populations might limit adoption.

Projection Summary: By 2030, Florbetapir F-18 revenues are expected to surpass $350 million globally, with potential for higher gains if its indications expand into preclinical populations and if integrated with therapeutic strategies.

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Conclusion

Florbetapir F-18 remains a cornerstone among amyloid imaging agents, with ongoing clinical studies confirming its diagnostic utility, particularly in Alzheimer’s disease. The product’s market is poised for sustained growth driven by demographic trends, advances in biomarker-driven diagnostics, and alignment with therapeutic development. However, competitors and economic considerations could influence its future trajectory. Continuous innovation, strategic partnerships, and evidence-based expansion of indications will be crucial for maintaining and growing Florbetapir F-18’s market presence.

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Key Takeaways

• Clinical validation of Florbetapir F-18 confirms its reliability for amyloid detection, catalyzing its integration into diagnostic protocols.

• Market size is projected at over $350 million globally by 2030, fueled by rising Alzheimer’s prevalence and expanded clinical applications.

• Competitive landscape is intensifying with emerging tracers and technological advances, necessitating ongoing innovation and strategic positioning.

• Regulatory and reimbursement policies are critical; favorable healthcare policies will accelerate adoption, especially in preclinical populations.

• Future expansion opportunities include leveraging Florbetapir F-18 as a companion diagnostic in amyloid-targeted therapies and early intervention models.

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FAQs

1. What is Florbetapir F-18 primarily used for?
Florbetapir F-18 is utilized in PET imaging to detect amyloid plaques in the brain, supporting the diagnosis of Alzheimer’s disease and differentiating it from other dementias.

2. How does Florbetapir F-18 compare with other amyloid tracers?
While Florbetapir F-18 has a relatively short half-life (~110 minutes) making it suitable for widespread clinical use, other tracers like Florbetaben and Flutemetamol offer similar diagnostic capabilities with minor pharmacokinetic differences.

3. What are the main barriers to wider adoption of Florbetapir F-18?
High costs, limited access to PET imaging facilities, reimbursement hurdles, and the availability of competing agents constrain broader implementation.

4. Are there efforts to expand the indications of Florbetapir F-18?
Yes, ongoing studies aim to validate its use in early, preclinical, and longitudinal settings, which could lead to label expansions in the future.

5. What role does Florbetapir F-18 play in clinical trials?
It is essential for patient stratification, monitoring therapeutic response, and validating amyloid-targeting drugs in Alzheimer’s research.

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References

[1] Nielsen, A. R., et al. (2021). Correlation of florbetapir PET with amyloid pathology confirmed by post-mortem analysis. Journal of Neuroimaging.
[2] Alzheimer's Disease International. (2022). World Alzheimer Report 2022: The Global Impact of Dementia.
[3] MarketsandMarkets. (2023). Neuroimaging Tracers Market by Type, Application, and Region—Forecast to 2030.