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TLX101 CDx

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Drug Profile

TLX101 CDx

Alternative Names: 18F-floretyrosine; 18F-FET; O-(2-[18F]fluoroethyl)-L-tyrosine; Pixclara; Pixlumi; TLX 101-Cdx; TLX101-Px

Latest Information Update: 23 Feb 2026

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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

  • 18 Feb 2026 Preregistration for Glioblastoma (Diagnosis) in European Union (IV)
  • 18 Feb 2026 Telix Pharmaceuticals plans to launch TLX101 CDx in Europe for the characterization of glioma
  • 22 Dec 2025 Telix Pharmaceuticals completes a Type A meeting with the US FDA to review the basis of the Complete Response Letter for New Drug Application (NDA) resubmission

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