Drug Profile

TLX101 CDx

Alternative Names: 18F-floretyrosine; ¹⁸F-FET; Pixclara3; TLX 101-Cdx

Latest Information Update: 25 Oct 2024

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At a glance

Originator Telix Pharmaceuticals
Class Diagnostic agents; Imaging agents; Radiopharmaceutical diagnostics; Small molecules
Mechanism of Action Positron-emission tomography enhancers; Radionuclide 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

Preregistration Glioblastoma

Most Recent Events

23 Oct 2024 FDA assigns PDUFA action date of 26/04/2025 for TLX101 CDx for Glioblastoma
23 Oct 2024 TLX101 CDx receives priority review status for Glioblastoma
23 Oct 2024 US FDA accepts NDA for TLX101 CDx for Glioblastoma

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