Drug Profile

FG 001

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

Latest Information Update: 16 Oct 2025

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At a glance

Originator FluoGuide
Class Diagnostic agents; Imaging agents
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

16 Sep 2025 FluoGuide announces intention to file IND application with the US FDA in USA for Glioma in 2025
16 Sep 2025 FluoGuide plans to file NDA application with the US FDA for Glioma
16 Sep 2025 FluoGuide receives positive FDA feedback on FG 001 in High-grade glioma

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