Clarity Pharmaceuticals (ASX:CU6) plans to start a phase 3 registrational trial of its copper-64-Sartate diagnostic agent in patients with neuroendocrine tumors after it agreed on all key components of the proposed trial design with the US Food and Drug Administration in an end-of-phase meeting, according to a Monday Australian bourse filing.

Recruitment for the trial is expected to start in 2026, and it will target around 70 participants.

The final study results are intended to support an application to the US FDA for the approval of copper-64-Sartate as a new diagnostic imaging agent in neuroendocrine tumors, the filing said.

Clarity Pharmaceuticals' shares fell nearly 1% in recent trading on Monday.