SpectronRx’s master file for Actinium-225 (Ac-225) trinitrate has been approved by Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate.
The file (MF #2025-132) is now available for reference in Canadian radiopharmaceutical clinical trial and drug submissions, which paves the way for expanded access to the isotope for cancer therapy development, the company said. Canadian researchers and pharmaceutical companies can now reference the master file by obtaining a letter of access from SpectronRx, which simplifies the submission process for new Ac-225 radiopharmaceuticals, SpectronRx said.
Ac-225 is a highly sought-after alpha-emitting isotope that shows promise for targeted cancer therapy. When attached to a targeting molecule, Ac-225-based radiopharmaceuticals can selectively deliver radiation to cancer cells, the company noted.
