Rilzabrutinib - Principia Biopharma
Alternative Names: PRN 1008; SAR-444671; WayrilzLatest Information Update: 11 Mar 2026
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
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Orphan Drug Status
Yes - Autoimmune haemolytic anaemia; Immunoglobulin G4-related disease; Idiopathic thrombocytopenic purpura; Sickle cell anaemia; Pemphigus; Pemphigus vulgaris
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- 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
Most Recent Events
- 02 Mar 2026 Rilzabrutinib - Principia Biopharma receives Orphan Drug status for Immunoglobulin G4 related disease in Japan
- 09 Feb 2026 Rilzabrutinib - Principia Biopharma receives Breakthrough Therapy status for Autoimmune haemolytic anaemia in USA
- 09 Feb 2026 Rilzabrutinib - Principia Biopharma receives Orphan Drug status for Autoimmune haemolytic anaemia in European Union