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.
The DISCO results, along with data from the earlier CL01 first-in-human trial, highlight the agent’s safety, tolerability, and potential to improve patient outcomes by enhancing detection and informing treatment strategies.
Clarity’s Executive Chair, Dr. Alan Taylor, emphasised the company's commitment to advancing next-generation theranostic products for cancers with high unmet needs and expressed gratitude to patients, collaborators, and the FDA for their role in bringing 64Cu-SARTATE closer to commercialisation.
At the time of reporting, Clarity Pharmaceuticals' share price was $3.28.