Trial Profile

A Pivotal Phase III trial of FG001 in Aggressive Brain Cancer

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 18 Nov 2025

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At a glance

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).
03 Jul 2025 According to a FluoGuide media release, prior to submitting the IND, the company plans to consult with FDA and expects to submit a pre-IND meeting request in July. Feedback from the FDA is anticipated by the end of Q3 or early Q4. To de-risk the IND process and enable focused FDA feedback, the company is preparing a robust preIND package that includes detailed information on completed development and proposed plans for remaining data generation.

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