Policy & Regulation
Curasight's uTREAT clinical trial application approved in Europe
26 August 2025 -

Curasight A/S (CPH: CURAS), a Denmark-based clinical stage radiopharmaceuticals company, announced on Tuesday that the European Medicines Agency (EMA) has approved its clinical trial application for the investigation of uTREAT in a phase 1 trial.

This trial is part of Curasight's theranostic strategy, focused on developing more gentle and targeted diagnosis and treatment of certain types of cancer. The first patient in the trial is expected to be dosed before the end of the year.

Curasight is now in clinical development with both its diagnostic (uTRACE) and therapeutic (uTREAT) platforms.

The phase 1 trial aims to investigate Curasight's uTREAT as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. Participants in the trial are patients with newly diagnosed verified or suspected GBM.

Curasight says that its uPAR theranostic platform combines two key technologies -- uTRACE and uTREAT -- both targeting the uPAR receptor. uTRACE is designed to deliver sensitive imaging for diagnosis, while uTREAT offers a targeted radiopharmaceutical solution. Together, they form an integrated approach to improving the diagnosis and treatment of cancers that express uPAR.

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