{"entity":{"id":"alphamedix","kind":"drug","name":"212Pb-DOTAMTATE","aka":[],"tldr":"An alpha-particle version of neuroendocrine radioligand therapy that produced responses in over half of patients who had never had PRRT, with FDA Breakthrough designation.","summary":"ALPHAMEDIX-02 (Sanofi/Orano Med/RadioMedix, October 2025): met all primary endpoints; ORR 54.3% in PRRT-naive patients with ~70-75% progression-free at about 3 years, and durable disease control in PRRT-exposed patients (~83% progression-free at 18 months). Breakthrough Therapy designation 2024. Sanofi acquired global rights (2024); registrational strategy under discussion. Supply relies on Orano Med's 212Pb generators.","status":"phase-2","asOf":"2026-09-07","links":[{"label":"Sanofi press release Oct 2025","url":"https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-08-05-00-00-3163053"}],"tags":[],"related":[],"cancers":["neuroendocrine"],"sections":[],"technologies":["prrt","targeted-alpha-therapy"],"targets":["sstr2"],"drugs":[],"companies":["orano-med","radiomedix","sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":["alphamedix-02"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"AlphaMedix","modality":"Targeted alpha therapy (lead-212)","mechanism":"DOTAMTATE (SSTR2 agonist) chelating 212Pb, which decays via 212Bi to emit an alpha particle at the tumour cell.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/alphamedix/","neighbours":{"cancer":[{"id":"neuroendocrine","kind":"cancer","name":"Neuroendocrine tumours","route":"/cancers/neuroendocrine/"},{"id":"pancreatic-net","kind":"cancer","name":"Pancreatic neuroendocrine tumours","route":"/cancers/pancreatic-net/"},{"id":"small-intestinal-net","kind":"cancer","name":"Small intestinal neuroendocrine tumours","route":"/cancers/small-intestinal-net/"}],"technology":[{"id":"actinium-225-supply","kind":"technology","name":"Actinium-225 supply: thorium stocks, accelerators and radium targets","route":"/technologies/actinium-225-supply/"},{"id":"prrt","kind":"technology","name":"Peptide receptor radionuclide therapy (PRRT)","route":"/technologies/prrt/"},{"id":"targeted-alpha-therapy","kind":"technology","name":"Targeted alpha therapy","route":"/technologies/targeted-alpha-therapy/"}],"target":[{"id":"sstr2","kind":"target","name":"Somatostatin receptor 2","route":"/targets/sstr2/"}],"company":[{"id":"orano-med","kind":"company","name":"Orano Med","route":"/companies/orano-med/"},{"id":"radiomedix","kind":"company","name":"RadioMedix","route":"/companies/radiomedix/"},{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}],"trial":[{"id":"alphamedix-02","kind":"trial","name":"ALPHAMEDIX-02","route":"/trials/alphamedix-02/"}],"pairing":[{"id":"prrt-then-alpha-net","kind":"pairing","name":"Beta PRRT → alpha PRRT","route":"/pairings/prrt-then-alpha-net/"}]}}