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Nipocalimab - Johnson & Johnson

Drug Profile

Nipocalimab - Johnson & Johnson

Alternative Names: Anti-FcRn monoclonal antibody - Johnson & Johnson; JNJ 80202135; M 281

Latest Information Update: 13 Feb 2024

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At a glance

  • Originator Momenta Pharmaceuticals
  • Developer Janssen Research & Development; Johnson & Johnson
  • Class Anti-inflammatories; Antianaemics; Antirheumatics; Monoclonal antibodies; Recombinant proteins
  • 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 - Haemolytic disease of newborn; Chronic inflammatory demyelinating polyradiculoneuropathy; Autoimmune haemolytic anaemia; Myasthenia gravis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Autoimmune haemolytic anaemia; Myasthenia gravis
  • Phase II/III Chronic inflammatory demyelinating polyradiculoneuropathy
  • Phase II Haemolytic disease of newborn; Myositis; Rheumatoid arthritis; Sjogren's syndrome; Systemic lupus erythematosus
  • Phase I Unspecified

Most Recent Events

  • 09 Feb 2024 Nipocalimab receives Breakthrough Therapy status for Haemolytic disease of newborn in USA
  • 10 Nov 2023 Efficacy and adverse events data from a phase-II clinical trials in Rheumatoid arthritis presented at the ACR Convergence 2023 ( ACR-ARP-2023)
  • 10 Nov 2023 Efficacy data from a phase-II clinical trials in Rheumatoid arthritis presented at the ACR Convergence 2023 ( ACR-ARP-2023)
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