FDA Receives IND for First Registration Trial of FG001 in High-Grade Glioma

FG001, a novel urokinase-type plasminogen activator receptor (uPAR)–targeted near-infrared imaging agent, is advancing toward its first US registration trial in patients with high-grade glioma following an investigational new drug (IND) application submission to the FDA, according to a press release from the developer, FluoGuide.^1,2

The submission represents a critical regulatory milestone as the FG001 program transitions into late-stage clinical development. This progress follows a pre-IND meeting with the FDA, where the developer reached an alignment on the design of the upcoming US phase 2 registration trial. Additionally, the meeting established the key elements for a subsequent phase 3 program intended to support a future new drug application (NDA) for the imaging agent in this patient population.

Notably, FG001 was granted orphan drug designation by the FDA in October 2023.³

According to the press release, several phase 2 clinical trials have demonstrated that FG001 is both effective and well-tolerated. To date, patients have received the imaging agent across various indications, including high-grade glioma, head and neck cancer, and lung cancer.⁴ In these clinical evaluations, the agent has shown the ability to light up cancer cells intraoperatively, providing surgeons with improved precision during the removal of malignant tissue.

FG001 is designed to bind to uPAR, a receptor that is expressed on the invasive front of many solid tumors, including high-grade gliomas, and is correlated with the aggressiveness of the disease. This expression pattern makes uPAR an ideal target for guiding surgical resection, as it is often concentrated at the exact boundary where the tumor meets healthy tissue.

The agent is administered to the patient prior to surgery. Once bound to the uPAR-expressing cancer cells, the agent illuminates the tumor to provide the surgical team with a clear optical guide, potentially allowing for more precise surgical outcomes and a reduction in local recurrence by ensuring that invasive malignant cells are visible during the procedure.

“The IND submission reflects focused execution across regulatory, clinical, and technical disciplines,” said Donna Haire, chief operating officer of FluoGuide, in the press release.¹ “I am very proud of the FluoGuide team and our collaborating neurosurgeons for delivering a high-quality IND package that reflects the maturity of the FG001 program and supports a clear path toward US registration trials in high-grade glioma—advancing our mission to maximize the outcomes for patients [with] this highly aggressive brain cancer.”

The upcoming US registration program is expected to consist of 2 clinical trials intended to support a future NDA. The first of these studies will be a phase 2 registration trial designed to establish a clear and structured path toward regulatory approval. Following the submission of the IND, the company will continue preparations for the trial.

Patient enrollment for the study is expected to commence in the second quarter of 2026. Both planned trials are expected to enroll patients over an approximate period of 1 year. By establishing this clinical infrastructure in the US, the developer aims to validate the efficacy of FG001 in a broader patient population while moving closer to providing a new standard for intraoperative imaging in the management of aggressive brain tumors.

“As we enter 2026, FluoGuide has reached a key inflection point. With the IND now submitted, we have further de-risked our lead program and established a well-defined regulatory path toward US approval. Our mission remains unchanged: to maximizing outcomes in cancer surgery. We are now well positioned to advance toward registration,” concluded Morten Albrechtsen, chief executive officer of FluoGuide.¹

Reference

1. FluoGuide submits an IND for FG001, to initiate first U.S. registration trial. News release. FluoGuide. January 21, 2026. Accessed January 22, 2026. https://tinyurl.com/mf2wjs2e
2. FluoGuide secures a pipeline of uPAR targeting products. News release. FluoGuide. April 23, 2020. Accessed January 22, 2026. https://tinyurl.com/mvpeszmn
3. FluoGuide receives FDA orphan drug designation for FG001 in high-grade glioma. News Release. FluoGuide. October 3, 2023. Accessed January 22, 2026. https://tinyurl.com/5d2exjzz
4. FluoGuide provides strategic update and outlines development plans towards commercialization of FG001. News release. FluoGuide. January 8, 2024. Accessed January 22, 2026. https://tinyurl.com/4cxxthn2