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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: 28 Nov 2025

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At a glance

  • Originator RayzeBio
  • Developer Ohio State University Comprehensive Cancer Center; 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 Meningioma; Triple negative breast cancer
  • No development reported Small cell lung cancer

Most Recent Events

  • 28 Nov 2025 No recent reports of development identified for phase-I development in Small-cell-lung-cancer(Combination therapy, Late-stage disease) in USA (IV, Infusion)
  • 24 Sep 2025 Phase-I/II clinical trials in Meningioma (Recurrent, Second-line therapy or greater) in USA (IV) (NCT07150806)
  • 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)

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