Rilzabrutinib
Rilzabrutinib, sold under the brand name Wayrilz, is an anti-cancer medication used for the treatment of immune thrombocytopenia. Rilzabrutinib is a tyrosine kinase inhibitor. It is taken by mouth.
Rilzabrutinib may increase the risk of serious infections. The most common side effects include diarrhea, nausea, headache, abdominal pain, and COVID-19.
Rilzabrutinib was approved for medical use in the United States in August 2025.
Medical uses
Rilzabrutinib is indicated for the treatment of adults with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.History
The safety and efficacy of rilzabrutinib was evaluated in a 24-week, double-blind, parallel-group study looking at durable platelet response. In this study, 202 participants were randomly assigned to either the rilzabrutinib group or placebo group. During the 24-week treatment period, 31 participants in the rilzabrutinib group and no participants in placebo group achieved a sufficient and durable platelet count response, as determined by the study.Society and culture
Legal status
Rilzabrutinib was approved for medical use in the United States in August 2025.In October 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Wayrilz, intended for the treatment of immune thrombocytopenia in adults who are refractory to other treatments. The applicant for this medicinal product is Sanofi B.V.
Names
Rilzabrutinib is the international nonproprietary name.Rilzabrutinib is sold under the brand name Wayrilz.