Ac-225, a decay product of thorium-229, has emerged as a promising radionuclide for targeted alpha therapy treatment for certain types of prostate, brain and neuroendocrine cancers. A huge fraction of Ac-225 used world-wide is supplied by ORNL, DOE Isotope Program. ORNL is gearing up meet the increased demands for supply of Ac-225 to various researchers/manufacturers for clinical use.

Ac-225 is one of the key radioisotopes that occur as the thorium decays and is derived from thorium-229 stocks maintained at Oak Ridge National Laboratory. A byproduct from past nuclear programs, the thorium material is processed regularly to separate the Ac-225 for distribution. The DOE Isotope Program announced that the U.S. Food and Drug Administration (FDA) has accepted its Type II Drug Master File (DMF) submission for Actinium-225 Nitrate (thorium-229 derived). This enables pharmaceutical companies to reference the document to support applications for their own Ac-225-based drugs without disclosing proprietary information. The FDA requires an active pharmaceutical ingredient to have an active drug master file before it will approve products containing that ingredient. This file contains information about Ac-225 derived from thorium-229, including materials used in its preparation, and the current Good Manufacturing Practice processes involved in its production.

Due to the high demand for Ac-225, the quantity of Ac-225 available by this route is fully committed this year and, the DOE IP is pursuing multiple other production routes for the isotope including accelerator-produced Ac-225.

To read more please visit:

https://www.isotopes.gov/Ac-225-DMF-accepted-by-FDA

Source: National Isotope Development Center