by
Gus Iversen, Editor in Chief | April 13, 2026
Radiopharm Theranostics has entered a clinical supply agreement with Siemens Healthineers to support late-stage development of its investigational imaging agent RAD101, as the company prepares for a Phase 3 registrational trial in the U.S.
The Sydney-based radiopharmaceutical developer said Siemens Healthineers will manufacture, radiolabel with fluorine-18, and distribute RAD101 doses through its U.S. radiopharmacy network. The agreement is intended to ensure consistent supply for the planned multicenter study.
RAD101 is a small-molecule PET imaging agent targeting fatty acid synthase (FASN), designed to help detect suspected recurrent brain metastases from solid tumors. The agent has received FDA Fast Track designation for distinguishing tumor recurrence from treatment-related effects, including in patients with leptomeningeal disease.
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The supply deal follows interim Phase 2b data indicating alignment between RAD101 PET imaging and MRI results. According to the company, 90% of evaluable patients (18 of 20) showed concordance on the study’s primary endpoint. The imaging agent also demonstrated uptake in brain metastases, with early follow-up data suggesting potential diagnostic sensitivity and specificity.
“This partnership marks a milestone for Radiopharm, as we bring RAD101 closer to improving diagnostic precision for brain metastases,” said Riccardo Canevari, CEO and managing director of Radiopharm Theranostics. “This partnership ensures our supply of 18F-labeled RAD101 in the U.S. for the initiation of the multicenter global Phase 3 registrational trial following our readout of topline data in the Phase 2b trial in the first half of 2026.”
Siemens Healthineers will leverage its existing PET manufacturing and distribution infrastructure in the U.S. to support the program.
“With our large national network of radiopharmacies in the U.S., we are uniquely qualified and well-equipped to deliver RAD101 as well as other novel PET biomarkers,” said Barry Scott, head of radiopharma at Siemens Healthineers.
Brain metastases affect an estimated 300,000 patients annually in the U.S., underscoring the need for more precise imaging tools in diagnosis and treatment monitoring.
