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Remibrutinib - Novartis

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Drug Profile

Remibrutinib - Novartis

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

Latest Information Update: 03 Oct 2025

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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

  • Registered Chronic urticaria
  • Phase III Hidradenitis suppurativa; Multiple sclerosis; Myasthenia gravis
  • Phase II Peanut hypersensitivity
  • Discontinued Asthma; Atopic dermatitis; Sjogren's syndrome

Most Recent Events

  • 30 Sep 2025 Preregistration for Chronic-urticaria in Japan (PO), before September 2025
  • 30 Sep 2025 Registered for Chronic spontaneous urticaria (Treatment-experienced) in USA (PO) - First global approval
  • 23 Jul 2025 Phase-III clinical trials in Multiple sclerosis (Treatment-experienced) in South Africa (PO) (NCT06846281)

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