Drug Profile

Rilzabrutinib - Sanofi

Alternative Names: PRN 1008; SAR-444671; Wayrilz

Latest Information Update: 14 Aug 2026

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At a glance

Originator Principia Biopharma
Developer 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 - Autoimmune haemolytic anaemia; Immunoglobulin G4-related disease; Idiopathic thrombocytopenic purpura; Sickle cell anaemia; Pemphigus; Pemphigus vulgaris
New Molecular Entity Yes

Marketed Idiopathic thrombocytopenic purpura
Phase III Autoimmune haemolytic anaemia; Immunoglobulin G4-related disease; Sickle cell anaemia
Phase II Focal segmental glomerulosclerosis; Graves' disease; Lipoid nephrosis
Discontinued Asthma; Atopic dermatitis; Chronic urticaria; Pemphigus; Pemphigus vulgaris

14 Aug 2026 Discontinued - Phase-II for Asthma (Treatment-experienced) in Hungary, Mexico, Chile, Canada, Germany, Bulgaria, Poland, Romania, South Korea, Spain, United Kingdom, Argentina, Turkey (PO) prior to August 2026 (Sanofi pipeline, August 2026)
14 Aug 2026 Discontinued - Phase-II for Chronic-urticaria in Italy, Netherlands, Japan, South Korea, Poland, Russia, Taiwan, Spain, Germany, Greece, Canada, Chile, Argentina (PO) prior to August 2026 (Sanofi pipeline, August 2026)
14 Aug 2026 Sanofi anticipates regulatory submissions for Immunoglobulin G4 related disease, Autoimmune haemolytic anaemia in the year 2028 (Sanofi pipeline, August 2026)

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