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Rilzabrutinib - Principia Biopharma

Drug Profile

Rilzabrutinib - Principia Biopharma

Alternative Names: PRN 1008; SAR-444671

Latest Information Update: 15 Mar 2024

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At a glance

  • Originator Principia Biopharma
  • Developer Principia Biopharma; Sanofi
  • Class 2 ring heterocyclic compounds; Amines; Anti-inflammatories; Antianaemics; Antiasthmatics; Fluorobenzenes; Nitriles; Phenyl ethers; Piperazines; Piperidines; Pyrazoles; 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.

    Yes - Idiopathic thrombocytopenic purpura; Pemphigus; Pemphigus vulgaris
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Idiopathic thrombocytopenic purpura
  • Phase II Asthma; Atopic dermatitis; Autoimmune disorders; Autoimmune haemolytic anaemia; Chronic urticaria
  • Discontinued Pemphigus; Pemphigus vulgaris

Most Recent Events

  • 15 Mar 2024 Discontinued - Phase-II for Pemphigus vulgaris in France, Israel, Croatia, Greece, Australia (PO), before March 2024 (Sanofi Pipeline, March 2024)
  • 15 Mar 2024 Discontinued - Phase-III for Pemphigus in Argentina, Australia, Brazil, Bulgaria, Croatia, Canada, USA, United Kingdom, Ukraine, Taiwan, Turkey, Spain, Serbia, Poland, Italy, Israel, Greece, Germany, France (PO), before March 2024 (Sanofi pipeline, March 2024)
  • 28 Feb 2024 Sanofi completes a phase II trial in Asthma (In adults, In the elderly, Treatment-experienced) in Argentina, Bulgaria, Canada, Chile, Germany, Hungary, South Korea, Mexico, Poland, Poland, Romania, Turkey, Spain and the United Kingdom (PO) (NCT05104892) (EudraCT2021-002490-26)
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