Drug Profile

Rilzabrutinib - Principia Biopharma

Alternative Names: PRN 1008; SAR-444671; Wayrilz

Latest Information Update: 23 Nov 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; Eye disorder therapies; 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; Pemphigus; Autoimmune haemolytic anaemia; Pemphigus vulgaris; Immunoglobulin G4-related disease
New Molecular Entity Yes

Marketed Idiopathic thrombocytopenic purpura
Phase III Autoimmune haemolytic anaemia; Immunoglobulin G4-related disease; Sickle cell anaemia
Phase II Asthma; Chronic urticaria; Focal segmental glomerulosclerosis; Graves' disease; Lipoid nephrosis
No development reported Liver disorders
Discontinued Atopic dermatitis; Pemphigus; Pemphigus vulgaris

24 Oct 2025 Sanofi initiates enrolment in the phase III LUNA 4 trial for Idiopathic thrombocytopenic purpura (Treatment-experienced) in USA (PO, Tablet) (NCT07007962)
17 Oct 2025 Sanofi receives CHMP recommendation for EU approval for rilzabrutinib in immune thrombocytopenia (In adults)
15 Oct 2025 Sanofi initiates enrolment in a phase III Open-label extension trial for Idiopathic thrombocytopenic purpura in Japan (PO) (NCT07216079)

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