The IND supports the initiation of the company’s first trial supporting registration in patients with high-grade glioma (HGG).

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, it states. Initiation of the first U.S. trial supporting registration remains on track, with enrollment of the first patient expected in Q2 2026.

Following the FDA green light on FluoGuide’s IND, the company will continue preparations to initiate the planned U.S. Phase 2 registration trial of FG001 in high-grade glioma. It will provide updates as appropriate, with first patient planned to enroll in Q2.
 
“We are excited to reach this FDA review milestone, keeping our program on track as we advance FG001 into our planned U.S. clinical trial” said Morten Albrechtsen, CEO of FluoGuide.

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.