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An Expanded Access Program for the Non-invasive Characterization of Glioma or Treatment Related Change Utilizing Fluorine (F-18) Floretyrosine (18F-FET, TLX101-CDx)

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Trial Profile

An Expanded Access Program for the Non-invasive Characterization of Glioma or Treatment Related Change Utilizing Fluorine (F-18) Floretyrosine (18F-FET, TLX101-CDx)

Status: Completed
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 03 Jun 2026

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At a glance

  • Drugs Fluorine 18 floretyrosine (Primary)
  • Indications Glioma
  • Focus Diagnostic use; Expanded access; Registrational
  • Sponsors Telix Pharmaceuticals

Most Recent Events

  • 29 May 2026 Status changed from recruiting to completed.
  • 10 Apr 2026 According to a Telix Pharmaceuticals media release, the United States (U.S.) Food and Drug Administration (FDA) has accepted the Company's resubmitted New Drug Application (NDA) for TLX101-Px1, (Pixclara, Floretyrosine F 18 or 18F-FET), an investigational PET agent for the imaging of glioma (brain cancer), and has assigned a PDUFA goal date of September 11, 2026.
  • 18 Feb 2026 According to a Telix Pharmaceuticals media release, the company has submitted MAA in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), and US NDA submission will follow. The company is aligning with aspects of USFDA package to support the additional application.

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