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Wayrilz FDA Approval History

FDA Approved: Yes (First approved August 29, 2025)
Brand name: Wayrilz
Generic name: rilzabrutinib
Dosage form: Tablets
Company: Sanofi
Treatment for: Immune Thrombocytopenia

Wayrilz (rilzabrutinib) is a kinase inhibitor indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Development timeline for Wayrilz

DateArticle
Aug 29, 2025Approval FDA Approves Wayrilz (rilzabrutinib) for Immune Thrombocytopenia
Jun  3, 2025Rilzabrutinib Granted Orphan Drug Designation in the US for Sickle Cell Disease
Apr  3, 2025Rilzabrutinib Granted Orphan Drug Designation in the US for Two Rare Diseases with No Approved Medicines
Dec  7, 2024Rilzabrutinib Demonstrated Significant Patient Benefit in the First Positive Phase 3 Study of a BTK Inhibitor in ITP
May 22, 2024New Results From Rilzabrutinib Phase 2 Study Show Potential to be First Advanced Oral Treatment for Moderate-to-Severe Asthma
Apr 14, 2022Positive Phase 1/2 Study Results of Rilzabrutinib in People with Immune Thrombocytopenia Published in The New England Journal of Medicine
Sep  9, 2021Sanofi Provides Update on Phase 3 Study Evaluating Rilzabrutinib for the Treatment of Pemphigus
Nov 18, 2020Rilzabrutinib Granted FDA Fast Track Designation for Treatment of Immune Thrombocytopenia

Further information

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