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Remibrutinib - Novartis

Drug Profile

Remibrutinib - Novartis

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

Latest Information Update: 26 Feb 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.

    No
  • 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

  • 19 Jan 2024 Novartis Pharmaceuticals completes a phase III REMIX-1 trial in Chronic-urticaria (In the elderly, Treatment-experienced, In adults) in Turkey, Russia, Taiwan, Mexico, Singapore, South Korea, Italy, Japan, Puerto Rico, India, France, Czech Republic, Colombia, Bulgaria, Australia, Argentina, Argentina, USA (PO) (NCT05030311) (EudraCT2021-000471-37)
  • 31 Dec 2023 Discontinued - Phase-II for Sjogren's syndrome in Germany, Denmark, Spain, USA, Australia, Belgium, Hungary, United Kingdom, Taiwan, Switzerland, China, Bulgaria (PO)
  • 14 Dec 2023 Novartis completes phase I pharmacokinetics and safety trial in patients with varying degrees of hepatic impairment and healthy volunteers in Hungary (PO) (NCT05753592)
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