# 212Pb-DOTAMTATE

Source: https://nuclide.cc/drugs/alphamedix/  
Nuclide record `alphamedix` (Agent). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Agent
- Status: phase-2
- Last checked: 2026-09-07
- 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.

## Sources

- Sanofi press release Oct 2025: https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-08-05-00-00-3163053

## Connected records

- isotopes: [Lead-212](https://nuclide.cc/isotopes/pb-212/)
- indications: [Neuroendocrine tumours](https://nuclide.cc/indications/neuroendocrine/), [Pancreatic neuroendocrine tumours](https://nuclide.cc/indications/pancreatic-net/), [Small intestinal neuroendocrine tumours](https://nuclide.cc/indications/small-intestinal-net/)
- technologies: [Actinium-225 supply: thorium stocks, accelerators and radium targets](https://nuclide.cc/technologies/actinium-225-supply/), [Alpha-emitter daughter redistribution ('free daughter' problem)](https://nuclide.cc/technologies/alpha-daughter-redistribution/), [Peptide receptor radionuclide therapy (PRRT)](https://nuclide.cc/technologies/prrt/), [Targeted alpha therapy](https://nuclide.cc/technologies/targeted-alpha-therapy/)
- targets: [Somatostatin receptor 2](https://nuclide.cc/targets/sstr2/)
- companies: [Orano Med](https://nuclide.cc/companies/orano-med/), [RadioMedix](https://nuclide.cc/companies/radiomedix/)
- trials: [ALPHAMEDIX-02](https://nuclide.cc/trials/alphamedix-02/)
- pairings: [Beta PRRT → alpha PRRT](https://nuclide.cc/pairings/prrt-then-alpha-net/)
- drugs: [Lead-212 VMT-alpha-NET](https://nuclide.cc/drugs/pb-212-vmt-alpha-net/)
- fronts: [Targeted alpha therapy](https://nuclide.cc/fronts/f-alpha-therapy/)
- roadmaps: [Alpha-emitter roadmap: radium-223 → 225Ac-PSMA-617 → a phase 3 pipeline](https://nuclide.cc/roadmaps/alpha-therapy-roadmap/), [SSTR theranostics roadmap: octreotide scintigraphy → 68Ga-DOTATATE → 177Lu-DOTATATE → alpha](https://nuclide.cc/roadmaps/sstr-theranostics-roadmap/)

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