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Iscalimab - Novartis

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Drug Profile

Iscalimab - Novartis

Alternative Names: CFZ-533; NVP-CFZ533; OM11-62-MF

Latest Information Update: 24 Apr 2025

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At a glance

  • Originator Novartis
  • Class Anti-inflammatories; Antihyperglycaemics; Antirheumatics; Monoclonal antibodies; Urologics
  • Mechanism of Action CD40 antigen 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

  • Phase II Graves' disease; Hidradenitis suppurativa; Liver transplant rejection; Lupus nephritis; Myasthenia gravis; Systemic lupus erythematosus; Type 1 diabetes mellitus
  • Phase I/II Renal transplant rejection
  • No development reported Rheumatoid arthritis
  • Discontinued Sjogren's syndrome

Most Recent Events

  • 31 Jan 2025 XOMA and Novartis terminated the iscalimab license agreement
  • 19 Aug 2024 Novartis completes the phase-II TWINSS Extn trial for Sjögren's Syndrome in Argentina, Italy, Turkey, Greece, Germany, Portugal, France, Netherlands, Sweden, Australia, Austria, Brazil, Canada, Chile, Colombia, Hungary, Israel, Japan, Romania, Russia, South Korea, UK and USA (SC) (NCT04541589)
  • 12 Jun 2024 Efficacy and adverse events data from a phase IIb TWINSS trial in Sjogren's syndrome presented at the25th Annual Congress of the European League Against Rheumatism (EULAR-2024)

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