Drug Profile

FG 001

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

Latest Information Update: 09 Apr 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

18 Mar 2026 FluoGuide plans a second phase II registration trial for Glioma in USA
18 Mar 2026 FG 001 receives Fast track status from the US FDA for Glioma
11 Mar 2026 US FDA approves IND application for FG 001 in Glioma

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