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A Pivotal Phase III trial of FG001 in Aggressive Brain Cancer

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Trial Profile

A Pivotal Phase III trial of FG001 in Aggressive Brain Cancer

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 20 Jul 2025

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At a glance

  • Drugs FG 001 (Primary)
  • Indications Brain cancer; Glioblastoma; Glioma
  • Focus Registrational; Therapeutic Use
  • Sponsors FluoGuide

Most Recent Events

  • 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.
  • 03 Jul 2025 According to a FluoGuide media release, the company remains on track to submit the IND application in H2 2025 to initiate U.S. clinical trial(s) of FG001. The company is continuing discussions with FDA to finalize the design.
  • 27 Nov 2024 According to a FluoGuide media release, updates expected in the first half of next year.

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