AMYVID (florbetapir f-18)
Amyvid is a radioactive diagnostic agent used for positron emission tomography (PET) imaging of the brain in adults with cognitive impairment. The drug is used to estimate the density of amyloid beta neuritic plaques to assist in the evaluation of Alzheimer’s disease and other causes of cognitive decline. Additionally, it serves as a tool for identifying patients who are candidates for amyloid beta-directed therapies.
How AMYVID Works
Florbetapir F 18 functions by binding to amyloid beta plaques and aggregates within the brain. The fluorine-18 isotope attached to the drug produces a positron signal that is detected by a PET scanner, allowing for the visualization of plaque density. In vitro studies indicate that the agent binds specifically to these plaques without detecting tau protein or other neuroreceptors.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-04-06
- Patent Cliff
- 2027
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
AMYVID Approval History
What AMYVID Treats
2 indicationsAMYVID is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Alzheimer's Disease
- Cognitive Decline
AMYVID Target & Pathway
ProTarget
AMYVID Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AMYVID
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06600880 FUS-AD | AAAV4854 | Ph 1 | not yet recruiting | Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau |
| NCT05164536 | Plasma P-tau 2017 | Ph 1 | completed | Plasma P-tau2017 and Quantitative Amyloid PET Imaging |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMYVID FDA Label Details
Indications & Usage
FDA Label (PDF)AMYVID is indicated for the treatment of Alzheimer's Disease; Cognitive Decline.
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Deep insights for AMYVID
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 32 active patents
Trial Analysis
- • 18 total trials
- • Stage: Declining
Competitive Landscape
- • 10 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment