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Remibrutinib - Novartis

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Drug Profile

Remibrutinib - Novartis

Alternative Names: Lapsid; LOU-064; LOU064-NXA; NVP-LOU064-NXA; Rapsid; Rhapsido

Latest Information Update: 16 Sep 2026

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At a glance

  • Originator Novartis
  • Class Amines; Anti-inflammatories; Antiallergics; Antiasthmatics; Benzamides; Cyclopropanes; Ethers; Fluorobenzenes; Pyrimidines; Skin disorder therapies; Small molecules
  • Mechanism of Action Agammaglobulinaemia tyrosine kinase 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

  • Marketed Chronic urticaria
  • Preregistration Familial dermographism
  • Phase III Food hypersensitivity; Hidradenitis suppurativa; Multiple sclerosis; Myasthenia gravis
  • Phase II Peanut hypersensitivity; Rosacea
  • Discontinued Asthma; Atopic dermatitis; Sjogren's syndrome

Most Recent Events

  • 11 Sep 2026 Novartis plans a phase III trial for Chronic urticaria (Treatment-resistant) in November 2026 (NCT07816328)
  • 10 Sep 2026 Phase-III clinical trials in Chronic-urticaria (Treatment-experienced) in USA (PO) (NCT07811869)
  • 01 Sep 2026 Efficacy and pharmacodynamics data from a phase III REMODEL-1 and REMODEL-2 trials in Multiple sclerosis released by Novartis

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