Ustekinumab - Janssen Biotech

Drug Profile

Ustekinumab - Janssen Biotech

Alternative Names: Anti-interleukin-12 p40 monoclonal antibody; CNTO-1275; STELARA; Stelara; Stellara; Sterrara; Suterara

Latest Information Update: 01 Jun 2018

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At a glance

  • Originator Centocor; Medarex
  • Developer Centocor; Janssen Biotech; Janssen Pharmaceutical KK; Janssen Research & Development; Janssen-Cilag
  • Class Antipsoriatics; Monoclonal antibodies
  • Mechanism of Action Immunosuppressants; Interleukin 12 subunit p40 inhibitors; Interleukin 23 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

  • Marketed Crohn's disease; Plaque psoriasis; Psoriatic arthritis
  • Phase III Spondylarthritis; Systemic lupus erythematosus; Ulcerative colitis
  • Phase II Atopic dermatitis
  • No development reported Inflammation
  • Discontinued Multiple sclerosis; Palmoplantar pustulosis; Primary biliary cirrhosis; Rheumatoid arthritis; Sarcoidosis

Most Recent Events

  • 14 May 2018 Janssen-Cilag International plans the LOTUS phase III trial for Systemic Lupus Erythematosus in Argentina, Australia, Bulgaria, China, Colombia, Ecuador, Germany, Hungary, Japan, South Korea, Lithuania, Peru, Philippines, Poland, Romania, Russia, Serbia, South Africa, Spain, Taiwan, Ukraine, USA , (EudraCT2017-001489-53)
  • 16 Apr 2018 Phase-III clinical trials in Systemic lupus erythematosus (Treatment-experienced) in Germany, Lithuania, USA (IV) (EudraCT2017-001489-53) (NCT03517722)
  • 16 Apr 2018 Phase-III clinical trials in Systemic lupus erythematosus (Treatment-experienced) in Lithuania, USA, Germany (SC) (EudraCT2017-001489-53) (NCT03517722)
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