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TLX 591 companion diagnostic - Telix Pharmaceuticals

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Drug Profile

TLX 591 companion diagnostic - Telix Pharmaceuticals

Alternative Names: 68Ga PSMA-11 - Telix Pharmaceuticals; 68Ga-HBED-CC-PSMA - Advanced Nuclear Medicine Ingredients; 68Ga-HBED-iPSMA PET; 68Ga-PSMA-11 - Advanced Nuclear Medicine Ingredients; 68Ga-PSMA-IRDye; 68Ga-PSMA-IRDye - Telix Pharmaceuticals; 68Ga PSMA-11 injection; Ga-68 gozetotide injection - Telix Pharmaceuticals; gallium-68 (68Ga) gozetotide injection - Telix Pharmaceuticals; Glu-urea-Lys(ahx)-hbed-CC; Illuccix; illumet; TLX 591CDx; TLX-591 companion diagnostic - Advanced Nuclear Medicine Ingredients/Telix Pharmaceuticals; TLX591-Cdx - Advanced Nuclear Medicine Ingredients/Telix Pharmaceuticals; TLX591-Sx; TLX591-Sx - Telix Pharmaceuticals

Latest Information Update: 27 Jun 2025

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At a glance

  • Originator Advanced Nuclear Medicine Ingredients
  • Developer BIOKOSMOS; Emory University; Kanazawa University; Telix Pharmaceuticals
  • Class Antineoplastics; Diagnostic agents; Imaging agents; Radiopharmaceutical diagnostics
  • Mechanism of Action Positron-emission tomography enhancers
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Prostate cancer
  • Registered Breast cancer

Most Recent Events

  • 23 Jun 2025 US FDA approves TLX 591 companion diagnostic for label expansion for patient selection for radioligand therapy
  • 13 Jun 2025 Registered for Prostate cancer (Diagnosis) in Greece (IV)
  • 04 Jun 2025 Registered for Breast cancer (Diagnosis) in Portugal (IV)

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