Drug Profile


Alternative Names: CSL 362AML; CSL-362; IL-13 MAb - CSL; JNJ 473; JNJ 56022473

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator CSL
  • Developer CSL; Janssen Biotech
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action Interleukin-3-receptor-alpha-subunit-antagonists; Natural killer cell stimulants
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Acute myeloid leukaemia
  • Phase II Myelodysplastic syndromes
  • Preclinical Systemic lupus erythematosus

Most Recent Events

  • 17 May 2017 Johnson & Johnson Pharmaceuticals announces intention to submit regulatory filings for talacotuzumab in Acute myeloid leukaemia in between 2017 and 2021
  • 09 May 2017 Phase-III clinical trials in Acute myeloid leukaemia (Combination therapy, In the elderly, Second-line therapy or greater) in Belgium, Spain, USA, Germany, Israel, Russia, Australia, United Kingdom, Taiwan, Poland, South Korea, Turkey, Sweden, France (IV) (NCT02472145)
  • 01 Feb 2017 Phase-II clinical trials in Myelodysplastic syndromes (In adults, In the elderly, Monotherapy, Second-line therapy or greater) in Spain (IV-infusion) (NCT03011034)
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