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FG 001

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Drug Profile

FG 001

Alternative Names: FG-001; FG001 sodium; ICG-Glu-Glu-AE105

Latest Information Update: 05 Feb 2026

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At a glance

  • Originator FluoGuide
  • Class Diagnostic agents; Diagnostic conjugates; Imaging agents; Small molecules
  • Mechanism of Action Diagnostic imaging enhancers
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Glioma
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Phase II Glioblastoma; Glioma; Head and neck cancer; Meningioma; Non-small cell lung cancer; Squamous cell cancer
  • No development reported Pancreatic cancer

Most Recent Events

  • 21 Jan 2026 FluoGuide files an IND application with the US FDA in US to initiate first phase II registration trial for Glioma
  • 21 Jan 2026 FluoGuide plans a Phase II registration trial for Glioma in the US in Q2 2026
  • 19 Dec 2025 FluoGuide announces intention to file IND application with the US FDA in USA for Glioma in mid-January 2026

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