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| Clinical data | |
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| Trade names | Wayrilz |
| Other names | PRN-1008 |
| AHFS/Drugs.com | Wayrilz |
| License data | |
| Routes of administration | By mouth |
| Drug class | Antineoplastic |
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| Legal status | |
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| Identifiers | |
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| CAS Number | |
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| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C36H40FN9O3 |
| Molar mass | 665.774 g·mol−1 |
| 3D model (JSmol) | |
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Rilzabrutinib, sold under the brand nameWayrilz, is ananti-cancer medication used for the treatment ofimmune thrombocytopenia.[1] Rilzabrutinib is atyrosine kinase inhibitor.[1] It is takenby mouth.[1]
Rilzabrutinib may increase the risk of serious infections (including bacterial, viral, or fungal).[2] The most common side effects include diarrhea, nausea, headache, abdominal pain, and COVID-19.[2]
Rilzabrutinib was approved for medical use in the United States in August 2025.[2]
Rilzabrutinib isindicated for the treatment of adults with persistent or chronicimmune thrombocytopenia who have had an insufficient response to a previous treatment.[1][2]
The safety and efficacy of rilzabrutinib was evaluated in a 24-week, double-blind, parallel-group study looking at durable platelet response (i.e., an increased number of platelets from baseline lasting the majority of the last twelve weeks of the treatment period).[2] In this study, 202 participants were randomly assigned to either the rilzabrutinib group (133) or placebo group (69).[2] During the 24-week treatment period, 31 (23%) participants in the rilzabrutinib group and no participants in placebo group achieved a sufficient and durable platelet count response, as determined by the study.[2]
Rilzabrutinib was approved for medical use in the United States in August 2025.[3]
In October 2025, theCommittee for Medicinal Products for Human Use of theEuropean 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.[4]
Rilzabrutinib is theinternational nonproprietary name.[5]
Rilzabrutinib is sold under the brand name Wayrilz.[2]
Rilzabrutinib is an oral, reversible covalent inhibitor ofBruton's tyrosine kinase, that may increaseplatelet counts in people withimmune thrombocytopenia by means of dual mechanisms of action: decreasedmacrophage (Fcγ receptor)–mediated platelet destruction and reduced production of pathogenicautoantibodies.[6]
This article incorporates text from this source, which is in thepublic domain.