FDA Clears FluoGuide's IND Application for FG001 in High-Grade Glioma
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.
The U.S. Food and Drug Administration has informed FluoGuide A/S that it can proceed with the proposed clinical investigation for FG001, supporting the initiation of the Company's first trial supporting registration in patients with high-grade glioma (HGG). Enrollment of the first patient is expected in Q2 2026.
The IND submission represents a key regulatory milestone for FluoGuide and marks the transition of FG001 to late-clinical development, advancing the program toward U.S. registration. An Investigational New Drug (IND) application is required to obtain U.S. regulatory authorization to initiate clinical trials of a new drug.
FG001 is a well-advanced, clinical-stage product, and significant portions of the submitted IND package, including the preclinical section, are expected to form the basis of the future New Drug Application (NDA) required to obtain approval to market FG001 in the U.S. Across the pre-IND and IND processes, FluoGuide engaged with the FDA to review a comprehensive development package covering completed work and proposed plans for ongoing studies.
FluoGuide received FDA alignment on the design of its U.S. Phase 2 clinical trial in HGG to support registration, as well as on key elements of the subsequent Phase 3 program. This regulatory alignment provides a strong foundation for long-term development planning, and in our view, de-risks the regulatory process as we advance toward NDA submission and future U.S. approval of FG001.
FluoGuide anticipates that two U.S. clinical trials will be required to support U.S. regulatory approval of FG001 for HGG. Both trials are expected to enroll patients over approximately one year, with final timelines and enrollment subject to emerging data and regulatory feedback. This program establishes a clear, structured and capital-efficient path toward U.S. approval of FG001 in HGG - a devastating brain cancer with poor outcomes and limited effective treatment options.
FG001 is designed to improve surgical precision by lighting up cancer intraoperatively. The improved precision has a dual benefit - it reduces both the frequency of local recurrence post-surgery and lessens surgical sequelae. FluoGuide has demonstrated that FG001 is both effective and well tolerated in several phase II clinical trials. The lead indications of FG001 are aggressive brain cancer (glioblastoma) and oral head and neck cancer.