Clarity Pharmaceuticals (ASX:CU6), a clinical-stage radiopharmaceutical company, has received positive guidance from the US Food and Drug Administration to proceed with a pivotal Phase 3 trial of its 64Cu-SARTATE diagnostic agent in patients with neuroendocrine tumours.
The trial, set to begin recruitment in 2026, will be a multi-centre, single-arm, open-label study involving approximately 70 participants, designed to support a potential FDA approval of 64Cu-SARTATE as a new diagnostic imaging agent for NETs.
The decision follows a end-of-phase meeting with the FDA, where the trial design was endorsed.
64Cu-SARTATE has demonstrated superior lesion detection compared with the current standard-of-care 68Ga-DOTATATE, particularly in the liver—the most common metastatic site for gastroenteropancreatic NETs—according to findings from Clarity’s Phase 2 DISCO trial.