FDA Clears IND for Phase 2 Registration Trial of FG001 in High-Grade Glioma

The FDA cleared an investigational new drug application (IND) for FG001, a fluorophore targeting the urokinase-type plasminogen activator receptor (uPAR), to proceed with a proposed clinical trial for patients with high-grade glioma, according to a press release from the agent’s developer, FluoGuide.¹ This regulatory milestone enables the company to expand its global clinical program into the United States, with the first domestic clinical site expected to open in the near future. FG001 is an optical imaging agent engineered to assist surgeons in the real-time visualization of cancer cells during surgical procedures, a critical factor in the treatment of patients with aggressive brain tumors.

Previously, developers submitted the IND for FG001 to the FDA in this high-grade glioma indication in January 2026.² In the meeting leading up to the submission of the IND, the developer and the FDA aligned on the design of the upcoming phase 2 trial in high-grade glioma. It was also reported that the meeting established certain key criteria for a phase 3 program, which is intended to support a new drug application for the imaging agent in the future.

The first US trial is planned to be phase 2 and initiated soon, with the first patient being enrolled in the second quarter of 2026. Notably, the developer anticipates that 2 clinical trials will be required to support regulatory approval for FG001 in high-grade glioma. The primary objective of FG001 is to improve the precision of surgical resections by making malignant cells light up during the operation. By targeting uPAR, a protein that is highly expressed in aggressive cancers like high-grade glioma, the agent allows for a clearer distinction between tumor tissue and healthy brain matter. The developer noted that the ability to visualize the tumor margins more accurately is intended to help surgeons remove more of the tumor tissue while minimizing damage to the surrounding healthy brain.

While the specific efficacy results in this high-grade glioma setting are limited, the move into this advanced stage of clinical testing is supported by earlier clinical evidence regarding the agent’s ability to highlight cancerous tissue. Additional indications for FG001 include aggressive brain cancer, such as glioblastoma, and oral head and neck cancer.

“We are excited to reach this FDA review milestone, keeping our program on track as we advance FG001 into our planned US clinical trial,” stated Morten Albrechtsen, chief executive officer of FluoGuide, in the press release.¹

The design of the phase 2 trial, as well as the key elements of a subsequent phase 3 program, have been agreed upon between developers and the FDA through pre-IND and IND interactions. The trial is expected to begin patient enrollment in the second quarter of 2026. The company projects that the 2 required trials will each enroll patients over a period of approximately 1 year, though final timelines remain subject to emerging data and further regulatory feedback. This structured clinical program aims to provide a capital-efficient path toward making FG001 a standard for intraoperative imaging in aggressive brain tumors.

Safety and tolerability are being continuously monitored as the program expands into the phase 2 setting. The FDA’s clearance of the IND application signifies that the regulatory agency has reviewed the existing safety data from previous clinical work. Across the other clinical indications, developers deemed FG001 to be well tolerated among patients.

References

1. FDA clears FluoGuide’s IND for FG001 in high-grade glioma, U.S. clinical trial remains on track. News release. FluoGuide. February 20, 2024. Accessed February 23, 2026. https://tinyurl.com/3nejb22x
2. FluoGuide submits an IND for FG001, to initiate first U.S. registration trial. News release. FluoGuide. January 21, 2026. Accessed February 23, 2026. https://tinyurl.com/mf2wjs2e