Guselkumab - Janssen Biotech

Drug Profile

Guselkumab - Janssen Biotech

Alternative Names: CNTO-1959; TREMFYA; Tremfya

Latest Information Update: 13 Jul 2018

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At a glance

  • Originator MorphoSys
  • Developer Janssen Biotech; MorphoSys; Taiho Pharmaceutical
  • Class Anti-inflammatories; Antipsoriatics; Antirheumatics; Monoclonal antibodies
  • Mechanism of Action Interleukin-23 subunit p19 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 Erythrodermic psoriasis; Plaque psoriasis; Psoriatic arthritis; Pustular psoriasis
  • Phase III Palmoplantar pustulosis
  • Phase II/III Crohn's disease
  • Phase II Rheumatoid arthritis

Most Recent Events

  • 10 Jul 2018 Janssen Research & Development plans the GALAXI phase II/III trial for Crohn's Disease in the US, Australia, Austria, Belarus, Bosnia and Herzegovina, Brazil, China, Colombia, Croatia, Czechia, France, Georgia, Greece, Ireland, Israel, Italy, South Korea, Lebanon, Lithuania, Russia, Slovakia, Slovenia, Spain, Turkey and Ukraine in April 2018 (NCT03466411)
  • 03 Jul 2018 Phase-II/III clinical trials in Crohn's disease in Germany (IV) (EudraCT2017-002195-13)
  • 03 Jul 2018 Phase-II/III clinical trials in Crohn's disease in Germany (SC) (EudraCT2017-002195-13)
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