NDAINTRAVENOUSSOLUTIONPriority Review
Approved
May 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
5/8 — Partial
Priority Review
AXUMIN (fluciclovine f-18) by Blue Earth Diagnostics is positron emitting activity [moa]. Approved for prostate cancer. First approved in 2016.
Drug data last refreshed 57m ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AXUMIN (Fluciclovine F-18) is a radioactive diagnostic agent administered intravenously as a solution for positron emission tomography (PET) imaging. It detects prostate cancer by emitting positrons that enable visualization of malignant cells. The drug works through positron-emitting activity to identify cancer lesions in prostate cancer patients.
Peak15.6 years to LOE
AXUMIN is at peak commercial stage with stable demand in the diagnostic imaging space; team expansion is likely limited given mature market positioning.
Mechanism of Action
Positron Emitting Activity
Pharmacologic Class:
Radioactive Diagnostic Agent
Indications (1)
Clinical Trials (2)
A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy
Started Nov 2024
3 enrolled
Brain Metastases
[18F]Fluciclovine in Post-treatment Glioblastoma ( Axumin )
Started Jun 2019
30 enrolled
Glioma Glioblastoma Multiforme
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.