Drug Profile

Rilzabrutinib - Principia Biopharma

Alternative Names: PRN 1008; SAR-444671

Latest Information Update: 18 Jun 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; Sickle cell anaemia; Autoimmune haemolytic anaemia; Pemphigus; Pemphigus vulgaris; Immunoglobulin G4-related disease
New Molecular Entity Yes

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

12 Jun 2025 Efficacy and adverse events data from a phase IIa trial in Immunoglobulin G4 related disease released by Sanofi
06 Jun 2025 Sanofi plans a phase III LUNA 4 trial for Idiopathic thrombocytopenic purpura in Unknown location (PO, Tablet) in July 2025 (NCT07007962)
03 Jun 2025 Preregistration for Idiopathic thrombocytopenic purpura in China (PO)

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