Radium-223 chloride - Bayer HealthCare

Drug Profile

Radium-223 chloride - Bayer HealthCare

Alternative Names: AC1O4D1M; Alpharadin; ATI-BC-1; BAY88-8223; Radium Ra 233 dichloride; Radium-223; Radium-223 dichloride; Xofigo

Latest Information Update: 16 Jul 2018

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At a glance

  • Originator Algeta
  • Developer Algeta; Bayer HealthCare; Janssen; Medica Scientia Innovation Research; Thomas Jefferson University; University of Texas M. D. Anderson Cancer Center; University of Utah
  • Class Antineoplastics; Radiopharmaceuticals; Small molecules
  • 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

  • Marketed Bone metastases
  • Phase II Prostate cancer
  • Phase I/II Multiple myeloma
  • No development reported Osteosarcoma
  • Discontinued Cancer pain

Most Recent Events

  • 13 Jul 2018 The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommends restricting use of radium-223 chloride (Xofigo) for Prostate cancer
  • 12 Feb 2018 Phase-II clinical trials in Prostate cancer (Second-line therapy or greater) in USA (IV) (NCT03304418)
  • 30 Nov 2017 The Independent Data Monitoring Committee recommends early unblinding of the phase III ERA223 trial in Prostate cancer
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