Atonco Report: Overview of Clinical Developments in Alpha-Emitting Radiotherapy
Atonco publishes its November 2025 report documenting the state of clinical research in alphatherapy worldwide. Compiled from the ClinicalTrials.gov database and recent scientific publications, this document maps all clinical trials conducted and underway with the three next-generation alpha-emitting radioisotopes: actinium-225, lead-212, and astatine-211. This analysis identifies major players, their strategic choices in terms of therapeutic targets and clinical indications, as well as industrial prospects for large-scale deployment of these promising technologies.
Current State of Affairs
Clinical alphatherapy is experiencing significant growth with 28 phase 1 or 1/2 studies registered in 2025, mobilizing both pharmaceutical giants (AstraZeneca, Bayer, BMS, J&J, Eli Lilly, Novartis) and numerous innovative biotechs. The three radioisotopes currently in development—actinium-225 (14 studies), lead-212 (6 studies), and astatine-211 (8 studies)—share a decisive advantage: their linear energy transfer is 100 times higher than that of lutetium-177, inducing irreparable breaks in both strands of tumor DNA. While actinium-225 dominates clinical trials thanks to its 10-day half-life enabling long-distance transport, astatine-211 stands out for its safe production in conventional cyclotrons and the absence of toxic long-lived daughter nuclides. In this context, Atonco has demonstrated the clinical feasibility of intravesical instillation of anti-CAIX labeled antibodies, confirming excellent bladder retention and superior radiocytotoxicity of astatine-211 compared to lutetium-177, paving the way for the phase 1 FIH study of ATO-101™ in refractory non-invasive bladder cancers. The future industrial availability of these radioisotopes, particularly through IBA’s developments for astatine-211, will determine their large-scale clinical deployment once their therapeutic performance is confirmed.
Keywords: Alphatherapy, Astatine-211, Actinium-225, Lead-212, Radioligand therapy, ATO-101, CAIX, Bladder cancer
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