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Axumin (fluciclovine (18F))
Axumin works by binding to specific sites in the body, emitting positrons that create images during PET scans.
At a glance
| Generic name | fluciclovine (18F) |
|---|---|
| Sponsor | Blue Earth Diagnostics Ltd |
| Drug class | Radioactive Diagnostic Agent [EPC] |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2016 |
Mechanism of action
Mechanism of action. Fluciclovine 18 is synthetic amino acid transported across mammalian cell membranes by amino acid transporters, such as LAT-1 and ASCT2, which are upregulated in prostate cancer cells. Fluciclovine 18 is taken up to greater extent in prostate cancer cells compared with surrounding normal tissues.
Approved indications
- Positron emission tomography
Common side effects
- Injection site pain
- Erythema
- Dysgeusia
Key clinical trials
- A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC) (PHASE2)
- Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging (PHASE3)
- Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial (PHASE2)
- 18F-Fluciclovine PET/CT in Multiple Myeloma (PHASE2)
- Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery (PHASE1)
- 18F-FLUC PET/MR in Patients With Brain Mets (PHASE3)
- 18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy (EARLY_PHASE1)
- Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Axumin CI brief — competitive landscape report
- Axumin updates RSS · CI watch RSS
- Blue Earth Diagnostics Ltd portfolio CI