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

Price :

$35 ^*

Note:

Adis is an information provider.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

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.

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial (opens in a new window)

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com