FG001

FG001 is a fluorophore developed by FluoGuide for use as an optical imaging agent in precision cancer surgery. It specifically targets the urokinase-type plasminogen activator receptor (uPAR), which is highly expressed on most solid tumor types. By binding to uPAR, FG001 enables real-time visualization of malignant tissue during surgery, helping surgeons distinguish cancerous from healthy tissue and improve surgical outcomes. The compound has the same spectral properties as indocyanine green (ICG), allowing it to be used with existing imaging equipment without modification. FG001 is administered intravenously prior to surgery and "lights up" cancer cells under appropriate imaging conditions, facilitating more complete tumor resection while sparing normal tissue. Clinical proof of concept has been demonstrated in phase II trials for aggressive brain cancer (high-grade glioma), head & neck cancer, and lung cancer. The FDA has granted Orphan Drug Designation to FG001 for visualization of malignant tissue during high-grade glioma surgery.