Trial Profile

A Pivotal Phase III trial of FG001 in Aggressive Brain Cancer

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 06 Jan 2026

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At a glance

19 Dec 2025 According to a FluoGuide media release, company has announced an update to the submission date for its for its Investigational New Drug (IND) application to mid-January 2026. This updated timeline relates to the IND application supporting this registration trial for FG001.
16 Sep 2025 According to a FluoGuide media release, the company has received positive feedback and alignment with the FDA which supports both the upcoming IND submission and a future NDA filing for FG001.
16 Sep 2025 According to a FluoGuide media release, the development plan of the company includes a Phase 2 and a phase 3 trial in the U.S. to support a New Drug Application (NDA).

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