AXUMIN (fluciclovine f-18)
Axumin is a radioactive diagnostic agent used for positron emission tomography (PET) imaging in men. It helps clinicians identify suspected prostate cancer recurrence in patients who show rising prostate specific antigen (PSA) levels after their initial treatment. This imaging tool allows for the visualization of potential cancer sites to assist in follow-up care.
How AXUMIN Works
This agent works by acting as a synthetic amino acid that enters cells through specific transporters, such as LAT-1 and ASCT2. These transporters are found in higher amounts on the surface of prostate cancer cells compared to healthy tissue. As a result, the drug is taken up more heavily by cancerous cells, making them visible during a PET scan.
Details
- Status
- Prescription
- First Approved
- 2016-05-27
- Patent Cliff
- 2042
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
AXUMIN Approval History
What AXUMIN Treats
1 indicationsAXUMIN is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prostate Cancer Recurrence
AXUMIN 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.
What's emerging in AXUMIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AXUMIN treats. First-in-class if their pivotal trials read out positive.
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.
AXUMIN FDA Label Details
Indications & Usage
FDA Label (PDF)AXUMIN is indicated for the treatment of Prostate Cancer Recurrence.
AXUMIN Patents & Exclusivity
Patents (8 active)
Pro Intelligence Preview
Deep insights for AXUMIN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 8 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.