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Rozanolixizumab - UCB

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Drug Profile

Rozanolixizumab - UCB

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

Latest Information Update: 06 Jun 2025

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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 Idiopathic thrombocytopenic purpura; Myelin oligodendrocyte glycoprotein antibody-associated disease
  • Phase II Chronic inflammatory demyelinating polyradiculoneuropathy; Encephalitis; Fibromyalgia

Most Recent Events

  • 12 May 2025 UCB completes phase I pharmacokinetics trial (In volunteers) in USA (SC) (NCT06720714)
  • 08 May 2025 UCB receives additional approval for new methods of administration for rozanolixizumab for the treatment of Myasthenia gravis by the Pharmaceuticals and Medical Devices Agency in Japan
  • 05 Apr 2025 Efficacy and adverse events data from a phase-III trial in Myasthenia gravis presented at the 77th Annual Meeting of the American Academy of Neurology 2025 (AAN-2025)

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