Telix, United Imaging explore U.S. theranostics research
Telix and United Imaging Healthcare North America will evaluate a U.S. research collaboration focused on scanner, software, AI, and radiopharmaceutical workflow integration.
Telix Pharmaceuticals and United Imaging Healthcare North America have signed a memorandum of understanding to evaluate a U.S. research collaboration in integrated theranostics.
The proposed work would combine United Imaging’s scanner platforms, software, connectivity, and AI capabilities with Telix’s molecular imaging portfolio and clinical protocols, according to Telix.
Pixclara, also known as TLX101-Px or Floretyrosine F 18, will be the initial focus in the U.S. The PET imaging candidate is under FDA new drug application review for glioma imaging.
Telix said early work under the MOU will include scanning protocol optimization, workflow support tool development and validation, and pilot programs linked to selected clinical applications.
The companies said the framework could support co-development, validation, and deployment of integrated theranostics workflows. Areas under review include imaging system and radiopharmaceutical workflow integration, protocol-driven imaging performance, treatment planning, monitoring, longitudinal patient management, and AI-enabled clinical decision support.
The FDA accepted Telix’s resubmitted NDA for TLX101-Px on April 10, 2026. The agency assigned a Prescription Drug User Fee Act goal date of September 11, 2026.
TLX101-Px has received FDA Fast Track and Orphan Drug designations for the characterization of recurrent or progressive glioma from treatment-related changes. Telix has said the Pixclara brand name remains subject to final regulatory approval.
The candidate has not received marketing authorization in any jurisdiction. Telix said expansion into additional markets and other Telix products or candidates would require mutual agreement.
Companies:Telix Pharmaceuticals, U.S. Food and Drug Administration
U.S. Food and Drug Administration coverage
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