The U.S. Department of Energy's Isotope Program will supply accelerator-produced actinium-225 (Ac-225) to a U.S.-based company for the first clinical trial using this radioisotope for cancer therapy, marking a significant milestone in radiopharmaceutical development. The clinical trial is scheduled to begin in summer 2025 and will be the first to rely on accelerator-produced Ac-225 for human patient care.
"We are proud to enable U.S. based companies to push past the boundaries on how we combat cancer in this country," said Christopher Landers, Director of the Office of Isotope R&D and Production. "This collaboration exemplifies the purpose of our mission to ensure that critical isotopes are readily available to meet domestic needs across all aspects of society, including medical therapies."
Addressing Critical Supply Shortage
Ac-225 is a radioisotope in short supply because of the current complicated production process. The DOE Isotope Program has established a scalable production method to fill this need using particle accelerators at Brookhaven National Laboratory and Los Alamos National Laboratory. This development opens a potential new pipeline for this lifesaving isotope and represents a breakthrough in addressing supply constraints that have limited clinical applications.
For many years, researchers have used accelerator-produced Ac-225 in developing potential cancer treatment options and in animal studies for safety and efficacy. The transition to clinical use marks a critical advancement from preclinical research to human patient applications.
Strategic Importance of Isotope Production
The Isotope Program produces critical radioactive and stable isotopes in short supply for the nation and is one of a few or only global producers for these novel isotopes. Isotopes are high-priority commodities of strategic importance and are essential in medical diagnosis and treatment, industrial applications in oil and gas, national security, quantum information systems, space exploration and communications, discovery science and various other applications.
This collaboration between the DOE and private industry demonstrates how government research infrastructure can enable emerging medical technologies. Isotopes directly enable emerging technology and contribute to the economic, technical, and scientific strength of the United States, positioning the country at the forefront of radiopharmaceutical innovation.
