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Rozanolixizumab - UCB

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Drug Profile

Rozanolixizumab - UCB

Alternative Names: Rozanolixizumab-noli; RYSTIGGO; UCB-7665

Latest Information Update: 23 Feb 2024

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At a glance

  • Originator UCB
  • Class Anti-inflammatories; Monoclonal antibodies
  • Mechanism of Action Neonatal Fc receptor antagonists
  • Orphan Drug Status

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

    Yes - Myasthenia gravis; Idiopathic thrombocytopenic purpura
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Myasthenia gravis
  • Phase III CNS disorders; Idiopathic thrombocytopenic purpura
  • Phase II Chronic inflammatory demyelinating polyradiculoneuropathy; Encephalitis; Fibromyalgia

Most Recent Events

  • 25 Jan 2024 UCB Biopharma completes a phase III trial in Myasthenia gravis in Denmark, Hungary, Belgium, Canada, China, Czech Republic, France, Georgia, Germany, Italy, Japan, Poland, Russia, Serbia, Spain and the US (EudraCT2020-003230-20) (NCT04650854)
  • 23 Jan 2024 UCB Biopharma's expanded-access programme for rozanolixizumab in Chronic inflammatory demyelinating polyradiculoneuropathy (In adults, In elderly) is no longer available (NCT05014724) .
  • 08 Jan 2024 Registered for Myasthenia gravis (In adults, Adjunctive treatment) in European Union (SC)
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