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Iscalimab - Novartis

Drug Profile

Iscalimab - Novartis

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

Latest Information Update: 05 Jul 2024

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At a glance

  • Originator Novartis; XOMA
  • Developer 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.

  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 04 Jun 2024 Novartis Pharmaceuticals completes a phase-II clinical trials in Type 1 diabetes mellitus (In children, In adults, In adolescents) in Belgium, Italy, Slovenia, Spain, United Kingdom (IV) (SC) (NCT04129528) (EudraCT2018-004553-25)
  • 10 Nov 2023 Efficacy and adverse events data from a phase IIb TWINSS trial in Sjogren's syndrome presented at the ACR Convergence 2023
  • 28 Jul 2023 Discontinued - Phase-II for Liver transplant rejection (Combination therapy) in Italy, USA, Netherlands, Argentina (SC) (Novartis pipeline, July 2023)
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