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A phase 2 trial of FG-001 in high-grade glioma (HGG)

Trial Profile

A phase 2 trial of FG-001 in high-grade glioma (HGG)

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 12 Feb 2026

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At a glance

  • Drugs FG 001 (Primary)
  • Indications Glioma
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 21 Jan 2026 According to a FluoGuide media release, the company has submitted IND application to US FDA for FG001. The IND supports the initiation of the Company' first registration trial in patients with high-grade glioma (HGG). The company expects to enroll the first patient expected in Q2 2026.
  • 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.
  • 27 Nov 2025 According to a FluoGuide media release, first patient enrollment in the U.S. Phase II registration trial expected in H1 2026.

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