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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: 15 Oct 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

  • 20 Jun 2025 Pharmacodynamics and adverse events data from a phase II trial in Type 1 diabetes mellitus presented at the 85th Annual Scientific Sessions of the American Diabetes Association (ADA-2025)
  • 28 Apr 2025 Novartis Pharmaceuticals completes a phase II trial in Systemic lupus erythematosus (In adults, In the elderly) in USA, Argentina, Australia, China, Czech Republic, France, Germany, Hungary, Israel, Spain, South Korea, Japan, Poland, Russia, Thailand and Taiwan (SC) (NCT03656562)
  • 31 Jan 2025 XOMA and Novartis terminated the iscalimab license agreement

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