Also known as: FluoGuide
FluoGuide A/S is a clinical-stage biotechnology company developing precision-cancer-surgery agents. Its lead program FG001 is in Phase II development and the company is based in Copenhagen, Denmark.
The U.S. FDA has granted Fast Track designation to FluoGuide's FG001 as an intraoperative imaging agent for high-grade glioma surgical resection. The designation follows IND clearance in January and enables accelerated development and regulatory review.
The U.S. Food and Drug Administration has cleared FluoGuide's Investigational New Drug application for FG001, enabling the company to proceed with a Phase 2 registration trial in high-grade glioma patients with first enrollment expected in Q2 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07609472 |
FG001 Near-Infrared Fluorescence Imaging During Tumor Resection in Newly Diagnosed High-Grade Glioma |
NOT_YET_RECRUITING | PHASE2 |
