Trial Profile

A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 22 Apr 2025

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At a glance

15 Apr 2025 According to a Telix Pharmaceuticals media release, Company is on track to submit an IND application in H1 2025, with the goal of commencing the study at U.S. sites in H2 2025.
24 Oct 2024 According to a Telix Pharmaceuticals media release, USFDA has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara). The application has been granted priority review and designated a PDUFA goal date of 26 April 2025, paving the way for a U.S. commercial launch in 2025.
03 Sep 2024 According to a Telix Pharmaceuticals media release, data from IPAX-1, IPAX-2 and IPAX-Linz studies, will inform the design of companys future registration-enabling trial for TLX101.

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