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TLX101 CDx

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Drug Profile

TLX101 CDx

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

Latest Information Update: 18 Apr 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

  • Phase III Glioblastoma

Most Recent Events

  • 15 Apr 2024 TLX101 CDx receives Fast track status from the US FDA for Glioblastoma (Diagnosis)
  • 12 Apr 2024 Telix Pharmaceuticals and University of California at San Francisco enters development and marketing agreement for TLX101 CDx in USA
  • 18 Oct 2023 Telix Pharmaceuticals plans to submit NDA to the US FDA for Glioblastoma (In adults, In children) in H1 of 2024
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