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Rilzabrutinib - Principia Biopharma

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Drug Profile

Rilzabrutinib - Principia Biopharma

Alternative Names: PRN 1008; SAR-444671

Latest Information Update: 22 Apr 2025

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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; Autoimmune haemolytic anaemia; Pemphigus vulgaris; Immunoglobulin G4-related disease
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Idiopathic thrombocytopenic purpura
  • Phase II Asthma; Autoimmune haemolytic anaemia; Chronic urticaria; Immunoglobulin G4-related disease
  • Preclinical Sickle cell anaemia
  • No development reported Liver disorders
  • Discontinued Atopic dermatitis; Pemphigus; Pemphigus vulgaris

Most Recent Events

  • 01 Apr 2025 Rilzabrutinib - Principia Biopharma receives Orphan Drug status for Immunoglobulin G4 related disease in USA
  • 20 Feb 2025 Rilzabrutinib - Principia Biopharma receives Orphan Drug status for Autoimmune haemolytic anaemia (Treatment-experienced) in USA
  • 07 Dec 2024 Adverse events and efficacy data from the phase-III LUNA3 trial in Idiopathic thrombocytopenic purpura presented at the 66th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2024) ,

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