Drug Profile


Alternative Names: CNTO-136; PLIVENSIA™; Shirukumabu

Latest Information Update: 26 Sep 2017

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At a glance

  • Originator Centocor
  • Developer Centocor; GlaxoSmithKline; Janssen Biotech
  • Class Antirheumatics; Monoclonal antibodies
  • Mechanism of Action Interleukin 6 inhibitors
  • 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

  • Preregistration Rheumatoid arthritis
  • Phase III Giant cell arteritis
  • Phase II Asthma; Lupus nephritis; Major depressive disorder
  • Preclinical Atherosclerosis

Most Recent Events

  • 22 Sep 2017 Janssen receives complete response letter from the FDA for sirukumab in Rheumatoid arthritis
  • 28 Aug 2017 GlaxoSmithKline withdraws phase IIa trial in asthma in USA and Spain, prior to enrolment (NCT02794519)
  • 02 Aug 2017 The US FDA Arthritis Advisory Committee did not recommend approval of sirukumab for Rheumatoid arthritis
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