Guselkumab

Drug Profile

Guselkumab

Alternative Names: CNTO-1959; TREMFYA

Latest Information Update: 19 Sep 2017

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At a glance

  • Originator MorphoSys
  • Developer Janssen Biotech; MorphoSys
  • 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Plaque psoriasis
  • Phase III Erythrodermic psoriasis; Palmoplantar pustulosis; Psoriatic arthritis
  • Phase II Rheumatoid arthritis

Most Recent Events

  • 19 Sep 2017 Janssen initiates enrolment in the phase III Discover-1 trial for Psoriatic arthritis in USA and Spain (NCT03162796) (EudraCT2016-001163-37)
  • 16 Sep 2017 Positive efficacy and safety data from the extension part (week 100) of the phase III VOYAGE 1 trial in Plaque psoriasis released by Janssen
  • 15 Sep 2017 Committee for Medicinal Products for Human Use (CHMP) recommends approval of guselkumab for Psoriasis in European Union
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