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Actinium-225 Dotate - RayzeBio

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Drug Profile

Actinium-225 Dotate - RayzeBio

Alternative Names: 225Ac-DOTATATE; RYZ-101

Latest Information Update: 10 Sep 2025

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At a glance

  • Originator RayzeBio
  • Class Antineoplastics; Drug conjugates; Peptides; Radioisotopes; Radiopharmaceuticals
  • Mechanism of Action Ionising radiation emitters
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Gastro-enteropancreatic neuroendocrine tumour
  • Phase I/II Triple negative breast cancer
  • Phase I Small cell lung cancer

Most Recent Events

  • 27 Aug 2025 Ohio State University Comprehensive Cancer Center plans a phase I/II PRIMe-STAR trial (Second-line therapy or greater, Recurrent)for Meningioma in USA (IV) in November 2025 (NCT07150806) (NCI-2025-06045)
  • 31 Jan 2025 Jules Bordet Institute collaboration with RayzeBio withdraw prior to enrollement phase I (AcTRESS) trial for Multiple myeloma (Late-stage disease, Second-line therapy or greater) in Belgium (IV) (NCT06411301)
  • 19 Jul 2024 Phase-I/II clinical trials in Triple-negative-breast-cancer (Combination therapy, Late-stage disease, Second-line therapy or greater, Metastatic disease, Inoperable/Unresectable) in USA (IV) (NCT06590857)

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