Radiopharm reaches FDA alignment on single Phase 3 trial design for RAD101

Radiopharm Theranostics announced on November 4, 2026 that it received final meeting minutes from its End-of-Phase 2 meeting with the FDA, reaching alignment with the FDA on the design of a pivotal Phase 3 trial to evaluate RAD101 in patients with indeterminate brain metastases following radiotherapy.¹

The trial is expected to enroll approximately 280 patients with indeterminate brain metastases from various solid tumor types after previous radiotherapy¹, with co-primary endpoints of sensitivity and specificity of RAD101 PET against a defined reference standard¹. The company said it expects to complete CRO selection in the fourth quarter 2026, initiate site activations and begin dosing patients in first half 2027¹.

RAD101 is designed to bind fatty acid synthase, a protein overexpressed in brain metastases, and prior Phase 2b data showed 93% concordance between MRI and PET imaging of brain metastases in a patient population with suspected recurrence¹, with substantial and selective tumor uptake, including in lesions that were equivocal on MRI¹. The drug carries an FDA designation under "Fast Track" status to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease¹.

CEO Riccardo Canevari said the companies size reflects unmet need, noting that the approximately 280-patient trial is substantially smaller than many historical registrational imaging studies, citing that prostate cancer imaging agents required two Phase 3 trials and more than 700 patients combined¹.

This follows the company's quarterly report filed October 30, 2026, which disclosed closing cash at the end of the quarter was $7.5 million, increasing from $4.1 million at the end of the prior quarter², and a Siemens Healthineers partnership to manufacture and distribute 18F-labeled RAD101 doses for the Phase 3 trial².