CLINICAL TRIALS PROFILE FOR VIZAMYL

All Clinical Trials for VIZAMYL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01607476 ↗	Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET)	Completed	Mayo Clinic	Phase 2	2012-07-01	The intent of this research protocol is to test the equivalency of two amyloid imaging drugs (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there will be no significant difference in the distribution of the agents to areas of amyloid deposition in the brain or to other normal brain structures. Recent data have shown similarity in the distribution of the drugs in subjects with Alzheimer's disease (AD) or mild cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects has been published. It is important to understand differences in the images and biodistribution from the two drugs in normal subjects as nonspecific accumulation of the drugs in brain structures such as white matter appear to differ slightly and could affect image performance.
NCT02317783 ↗	Amyloid Plaque Deposition in Chemotherapy-Induced Cognitive Impairment	Recruiting	University of Utah	Phase 2	2018-01-31	The initial goal of the investigators interdisciplinary group of imagers, oncologists, neurologists, neuro-psychologists, and biostatisticians is to obtain proof of concept pilot data for eventual submission of a National Cancer Institute Quick-Trial for Imaging and Image-Guided Interventions: Exploratory Grant (R10) depending on the results of this pilot study. The overall objective is to use [18F]Flutemetamol, FDG-PET, and MRI to better understand CICI, which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy.2,3 To date there have been few studies examining this problem using multi-modality imaging techniques to better understand this complex and significant problem. FDG-PET and MRI are routinely used in clinical practice for the evaluation of cognitive dysfunction in older populations complaining of memory dysfunction. It is well recognized that FDG-PET can assist with the differentiation and characterization of various cognitive disorders due to unique patterns of cerebral metabolism caused by various cognitive and dementia-causing disorders.4-6 FDG-PET has been studied extensively in dementia research and has a high reliability in detecting Alzheimers disease (AD) many years before it can be diagnosed reliably using clinical criteria.4 To the investigators knowledge, there has been only a single small study using FDG-PET and bolus water activation paradigms in cancer patients complaining of memory problems.7 To date, there have been no studies using [18F]Flutemetamol as a PET imaging agent to assess the possibility of increased amyloid plaque burden as a potential contributing factor to the cognitive deficits and complaints seen in patients experiencing CICI. The novel feature of this project is in the combined use of [18F]Flutemetamol-PET, FDG-PET, and anatomic MRI to study a poorly understood but common problem: cognitive impairment in breast cancer patients treated with chemotherapy. If [18F]Flutemetamol, FDG-PET, and MRI can provide information on the pathophysiology of this disorder, it will be an important step in better understanding the etiology of this phenomenon and possibly other conditions resulting in cognitive dysfunction. These imaging assessments will make it possible to explore any altered changes in cerebral structure, metabolism, and amyloid deposition that may be responsible for CICI. This may help to predict which individuals may be affected by this problem and provide information for eventual therapeutic strategies to treat this common cancer-associated disorder. This study will use [18F]Flutemetamol and FDG-PET imaging to assess and quantify the amyloid plaque burden and cerebral glucose metabolism, respectively, in breast cancer patients suffering from CICI and correlate those findings with structural changes on MRI. The [18F]Flutemetamol and FDG-PET scans of these study patients will then be compared to two GE software databases (CortexID-FDG and CortexID-Flutemetamol) which contain scan data from healthy control individuals to evaluate for abnormalities in cerebral glucose metabolism and amyloid plaque burden differing from the values expected for individuals in their age range.
NCT02353949 ↗	Investigating the Clinical Consequences of Flutemetamol-PET-scanning	Terminated	ETH Zurich	Phase 3	2015-05-01	The study examines subjects where there might be an indication for Amyloid-PET according to the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and disease course will be studied over 6 months.
NCT02353949 ↗	Investigating the Clinical Consequences of Flutemetamol-PET-scanning	Terminated	University of Zurich	Phase 3	2015-05-01	The study examines subjects where there might be an indication for Amyloid-PET according to the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and disease course will be studied over 6 months.
NCT02778971 ↗	Implications for Management of PET Amyloid Classification Technology	Recruiting	University of Utah		2016-06-01	The main purpose of this study is to explore the impact of an amyloid positron emission tomography and computed tomography (PET/CT) scan on physician diagnosis and management, including drug management and care practices, for patients with a diagnosis of cognitive impairment. This study also intends to capture specific patient-reported outcomes related to patient burden, confidence and satisfaction. The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain etiology for their dementia will benefit from knowledge of amyloid plaque burden status, through an alteration of patient diagnosis and management, which will lead to significant changes in patient and care partner reported outcomes.
NCT03232632 ↗	Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries.	Terminated	University Hospital, Toulouse	Early Phase 1	2017-03-15	To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.

Clinical Trial Conditions for VIZAMYL

Condition Name

Condition Name for VIZAMYL
Intervention	Trials
Alzheimer's Disease	3
Dementia	2
Mild Cognitive Impairment	2
Breast Cancer	1

Condition MeSH

Condition MeSH for VIZAMYL
Intervention	Trials
Cognitive Dysfunction	3
Cognition Disorders	3
Alzheimer Disease	3
Mild Cognitive Impairment	2

Clinical Trial Locations for VIZAMYL

Trials by Country

Trials by Country for VIZAMYL
Location	Trials
United States	3
Switzerland	2
France	1

Trials by US State

Trials by US State for VIZAMYL
Location	Trials
Utah	2
Minnesota	1

Clinical Trial Progress for VIZAMYL

Clinical Trial Phase

Clinical Trial Phase for VIZAMYL
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for VIZAMYL
Clinical Trial Phase	Trials
Recruiting	2
Terminated	2
Completed	1

Clinical Trial Sponsors for VIZAMYL

Sponsor Name

Sponsor Name for VIZAMYL
Sponsor	Trials
University of Utah	2
Yale University	1
Mayo Clinic	1

Sponsor Type

Sponsor Type for VIZAMYL
Sponsor	Trials
Other	7

VIZAMYL (florbetaben F 18): Clinical Trials Update, Market Landscape, and Revenue Projection

Last updated: May 22, 2026

VIZAMYL (florbetaben F 18) is a diagnostic PET radiotracer for amyloid-beta (Aβ) plaques in the brain. The current market and trial outlook is constrained by limited approved territories, product-specific procurement dynamics for imaging agents, and the competitive shift toward broader radiotracer options and platform-style contracting in radiopharmaceutical imaging. A precise, data-backed market and trial projection requires country-specific utilization, contracted volumes, and payer or nuclear medicine network adoption rates, which are not provided here.

What is VIZAMYL (florbetaben F 18) and what indications are approved?

Featured snippet answer: VIZAMYL is an ^18F-labeled amyloid PET radiopharmaceutical used to assess cerebral amyloid pathology in patients evaluated for Alzheimer’s disease.

What does florbetaben PET measure

• Amyloid-beta plaque burden using PET imaging with fluorine-18 labeled florbetaben.
• Intended to support evaluation of Alzheimer’s disease in clinical practice (label-specific language varies by jurisdiction).

Where is VIZAMYL approved

Approval and reimbursement differ by jurisdiction (EU member states vs US). Any market model must be built on the exact approved geography and reimbursement access.

How has the clinical trial pipeline for VIZAMYL evolved?

Featured snippet answer: A clinically active pipeline is inconsistent over recent periods for florbetaben; the practical R&D focus has largely shifted from basic diagnostic validation toward comparative performance, workflow integration, and substitution effects from competing amyloid PET tracers.

Trial types that typically drive amyloid PET adoption

• Diagnostic performance studies vs standard-of-care reference (clinical diagnosis, CSF biomarkers, neuropathology where available).
• Reproducibility and scan protocol standardization.
• Reader training and harmonization studies for multicenter interpretability.
• Longitudinal studies that correlate amyloid signal with clinical progression or treatment response in trials using anti-amyloid therapies.

What to track in “clinical trials update” for amyloid PET

• Phase/study status: recruiting, active, completed.
• Comparator: other amyloid tracers, CSF Aβ42/Aβ40 ratios, or amyloid pathology classification.
• Imaging endpoints: standard uptake value ratio thresholds, composite cortical binding measures, and reader agreement metrics.
• Site footprint: number of nuclear medicine centers and geographic spread.
• Regulatory endpoint framing: alignment to label language and labelling-specific claims.

Which VIZAMYL clinical trials are most relevant for regulatory and payer adoption?

Featured snippet answer: Studies that establish reproducibility, reader concordance, and correlation to established amyloid pathology references tend to have the highest value for regulatory maintenance and for hospital procurement decisions.

Key evidence categories

• Inter-reader agreement: reduces operational variability in routine interpretation.
• Protocol transferability: supports standardization across sites.
• Threshold validation: supports “positive vs negative” classification consistency.

What patents and exclusivity affect VIZAMYL market entry and competition?

Featured snippet answer: For radiotracers, market exclusivity is driven by the authorized product dossier and specific formulation and manufacturing/process claims, plus regulatory data protections tied to approval pathways. The competitive threat often comes from alternative commercially available amyloid tracers rather than classic “generic” entry.

How competition typically materializes in radiopharmaceuticals

• Substitution among amyloid PET tracers with different labels, supply chains, and contractual pricing.
• Greater contracting power of large radiopharmacy networks that can qualify multiple tracers.
• Procurement bundling in hospital imaging services.

What is the Orange Book status of VIZAMYL, and does it have generic risks?

Featured snippet answer: VIZAMYL is not generally modeled like an orally administered small-molecule where generic substitution is routine. The “generic risk” profile is instead driven by radiopharmacy authorization, method-of-production qualification, and tracer-specific regulatory pathways.

Why generic-style entry is different for PET tracers

• Short half-life and site logistics limit “generic” analogs.
• Regulatory approval typically requires full chemistry, manufacturing, and controls and PET tracer performance evidence in a specific system.

Which companies compete with VIZAMYL in amyloid PET imaging?

Featured snippet answer: Competitive pressure comes from other FDA/EMA-authorized amyloid PET tracers, plus imaging service contracting that favors supply reliability and interpretive workflow fit.

Competitive axes that matter commercially

• Supply chain stability and regional radiopharmacy coverage
• Cost per scan under hospital contracting
• Label alignment with site-level protocols and reader workflows
• Availability in peak imaging demand windows
• Training materials and standardized interpretation toolkits

How big is the amyloid PET market, and where does VIZAMYL fit?

Featured snippet answer: The amyloid PET market is a niche within neuroimaging driven by dementia workflows, anti-amyloid clinical trial activity, and biomarker substitution preferences across neurology and radiology networks.

Market sizing mechanics (what a working model must include)

• Number of eligible scans per region:
  • Early Alzheimer’s workups
  • Differential diagnosis use cases
  • Clinical trial enrichment biomarker screening
• Reimbursement coverage and patient access:
  • Medicare vs commercial payer rules (country-specific)
  • Evidence requirements for medical necessity
• Imaging facility capacity:
  • PET center throughput and scanner availability
  • Radiopharmacy distribution latency
• Competitive substitution:
  • Trace-to-trace switching within hospital networks

What drives demand for VIZAMYL specifically?

Featured snippet answer: VIZAMYL demand tracks availability, contracting terms with radiopharmacies, and how its label and operational characteristics map onto site selection for amyloid PET.

Site selection drivers

• Radiopharmacy lead time and capacity to supply same-day or schedule-consistent deliveries
• Scan workflow integration and reader training programs
• Cost predictability for hospital imaging budgets
• Institutional familiarity with interpretation criteria and reporting systems

When does VIZAMYL lose exclusivity?

Featured snippet answer: Loss of exclusivity depends on the exact patent and regulatory data protection schedule in each territory and on whether key process or dossier rights are time-limited or perpetuated through lifecycle maintenance. Without territory-specific patent and exclusivity tables, a definitive “date” cannot be produced.

What is the likely market trajectory for VIZAMYL over the next 3–5 years?

Featured snippet answer: The near-term trajectory is more likely to reflect substitution dynamics and contracting decisions among radiopharmacy networks than broad category expansion. Growth, if it occurs, is tied to continued anti-amyloid therapy development and biomarker-led diagnosis adoption.

Scenario structure for a defensible projection

A workable projection must segment by:

• Geographic territory (approved and reimbursed markets)
• Contracting channel:
  • Hospital-owned PET centers vs shared imaging networks
  • Radiopharmacy-distribution footprint
• Volume drivers:
  • Alzheimer’s diagnostic pathway intensity
  • Anti-amyloid therapy trial activity and screening volumes
• Retention vs switching:
  • Whether networks keep the same tracer across contract cycles

What revenue model inputs should be used for VIZAMYL forecasts?

Featured snippet answer: For PET tracers, revenue forecasting requires scan-volume inputs plus net pricing under institutional contracts.

Model inputs

• Annual scan volumes by territory
• Net realized price per scan:
  • list vs contract discounts
  • bundle pricing with radiopharmacy services
• Cost pass-through assumptions (production and distribution logistics)
• Supply constraints:
  • cyclotron capacity or outsourcing arrangements
• Competitive pricing pressure over contract renewals

Key Takeaways

• VIZAMYL (florbetaben F 18) is an amyloid PET radiotracer used to assess Aβ plaque pathology in Alzheimer’s disease evaluations.
• Commercial traction is driven by imaging network contracting, radiopharmacy supply coverage, and tracer substitution dynamics rather than classic small-molecule generic competition.
• A high-confidence market projection requires territory-specific approval and reimbursement access, contracted net pricing, and scan volume data by imaging center and radiopharmacy network.

FAQs

1. What does florbetaben PET show and how is it interpreted in clinical reporting?
2. How do radiopharmacy supply logistics and half-life constraints affect amyloid PET tracer market adoption?
3. What clinical endpoints in amyloid PET trials most influence reimbursement and guideline inclusion?
4. How do anti-amyloid therapy programs change amyloid PET scan demand and timing?
5. How does competitive substitution among amyloid PET tracers impact long-term pricing for VIZAMYL?

References

1. FDA. “VIZAMYL (florbetaben F 18) prescribing information.” (source to be used for label specifics).
2. EMA. “Vizamyl (florbetaben (18F)) summary of product characteristics.” (source to be used for EU label specifics).
3. ClinicalTrials.gov. “Florbetaben (18F) studies.” (source to be used for trial status and protocol details).