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Ianalumab - MorphoSys/Novartis

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Drug Profile

Ianalumab - MorphoSys/Novartis

Alternative Names: NOV-5; NVP-VAY736; VAY-736

Latest Information Update: 27 Feb 2026

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At a glance

  • Originator MorphoSys; Novartis
  • Class Anti-inflammatories; Antianaemics; Antifibrotics; Antineoplastics; Antirheumatics; Hepatoprotectants; Immunotherapies; Monoclonal antibodies; Skin disorder therapies; Urologics
  • Mechanism of Action Antibody-dependent cell cytotoxicity; B-cell activation factor receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Sjogren's syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Autoimmune haemolytic anaemia; Idiopathic thrombocytopenic purpura; Lupus nephritis; Sjogren's syndrome; Systemic lupus erythematosus
  • Phase II/III Autoimmune hepatitis
  • Phase II Hidradenitis suppurativa; Rheumatoid arthritis; Systemic scleroderma
  • Phase I Non-Hodgkin's lymphoma
  • Discontinued Chronic lymphocytic leukaemia; Idiopathic pulmonary fibrosis; Multiple sclerosis; Pemphigus vulgaris

Most Recent Events

  • 19 Feb 2026 Novartis Pharmaceuticals plans a phase II VAY2EXPLORE trial for Idiopathic thrombocytopenic purpura (Combination therapy, Treatment-experienced) in June 2026 (NCT07421167)
  • 13 Feb 2026 Novartis intends to file regulatory applications for approval of Ianalumab for first-line and second-line immune thrombocytopenia in 2027 (Novartis pipeline, December 2025)
  • 04 Feb 2026 Novartis announces intention to submit regulatory applications for Sjogren's syndrome in 2026 (Novartis pipeline, December 2025)

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