Product Description
Fluciclovine F18 is a radiotracer containing a synthetic amino acid analogue of L-leucine radiolabeled with fluorine F 18 with potential diagnostic imaging use. Similar to most amino acids, fluciclovine F18 appears to enter cells through the energy-independent L-type amino acid transporter (LAT) system. Fluciclovine ((18)F) is a member of the class of cyclobutanes that is cyclobutane which carries a carboxy, amino and ((18)F)fluoro groups at positions 1, 1 and 3, respectively (the 1r,3r-stereoisomer). (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Fluciclovine-_18F)
Mechanisms of Action: Imaging Agent
Novel Mechanism: No
Modality: Diagnostic Agent
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Austria | Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Italy | Japan | Korea | Latvia | Lithuania | Netherlands | Norway | Poland | Portugal | Slovakia | Spain | Sweden | Taiwan | United States
Approved Indications: Prostate Cancer | Oncology Unspecified
Known Adverse Events: Dysgeusia | Pain Unspecified | Erythema
Company: Blue Earth Diagnostics
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, China, United States
Active Clinical Trial Count: 11
Highest Development Phases
Phase 3: Brain Cancer|Prostate Cancer
Phase 1: Alzheimer Disease|Bladder Cancer|Glioma|Transitional Cell Carcinoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| STUDY00003150 | P2 |
Recruiting |
Brain Cancer |
2026-10-31 |
|
| S67792 | P3 |
Unknown Status |
Unknown |
2026-10-01 |
|
| FACILITATE | P1 |
Recruiting |
Brain Cancer |
2026-05-01 |
|
| NCT05553041 | P1 |
Recruiting |
Glioma |
2025-12-01 |