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Remibrutinib - Novartis

Drug Profile

Remibrutinib - Novartis

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

Latest Information Update: 06 Jun 2024

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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.

  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 31 May 2024 Updated pooled efficacy and adverse events data from the REMIX-1 and REMIX-2 trials in Chronic urticaria released by Novartis
  • 13 May 2024 Phase-III clinical trials in Chronic-urticaria (In children, In adolescents) (PO), before May 2024 (Novartis pipeline, May 2024)
  • 25 Apr 2024 Novartis completes a phase-III trial for Chronic-urticaria (In adults, In the elderly, Treatment-experienced) in Argentina, Canada, South Korea, Singapore, Spain, France, USA, Slovakia, Germany and Turkey (NCT05795153) (EudraCT2022-002838-13)
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