FluoGuide receives positive FDA feedback on FG001 in high-grade glioma
Copenhagen, Denmark, 16 September 2025 – FluoGuide A/S ("FluoGuide" or the "Company") received positive feedback and alignment with the FDA at a pre-IND consultation on its U.S. clinical study design. This supports both the upcoming IND submission and a future NDA filing for FG001, an intraoperative imaging agent for high-grade glioma (HGG).
FluoGuide has achieved several important milestones in 2025. Our comprehensive pre-IND package included detailed information on completed development activities to support the upcoming IND (Investigational New Drug) and outlined proposed plans for continued studies. Our development plan includes one Phase 2 and one Phase 3 clinical trial in the U.S. to support a New Drug Application (NDA), the formal submission to the FDA required for approval before a drug can be marketed in the U.S.
Importantly, FluoGuide received FDA alignment on its U.S. high-grade glioma (HGG) Phase 2 clinical trial design and key elements of its future Phase 3 clinical program. This regulatory alignment provides a strong foundation for the IND submission, supports long-term development planning, and in our view, de-risks the overall regulatory strategy toward NDA submission. This positions the company to advance its clinical programs with greater confidence and long-term clarity.
Therefore, we also maintain our milestone to submit an IND application for the U.S. Phase 2 clinical registration trial in HGG in Q4 2025. FluoGuide will provide additional information on the development program following submission of the IND application.
Morten Albrechtsen, CEO of FluoGuide said: “FluoGuide has made substantial progress during 2025. With the constructive feedback from FDA, we believe we have further de-risked the path towards approval, while maintaining our overall plan to submit the IND before year end.”