What Was Approved?
On August 29, 2025, the U.S. Food and Drug Administration approved Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia, or ITP, who have had an insufficient response to previous treatment.
ITP is an autoimmune disorder that can cause abnormally low platelet counts and increase the risk of bleeding.
How Does Wayrilz Work?
Wayrilz is a Bruton’s tyrosine kinase, or BTK, inhibitor.
It affects immune signaling involved in the abnormal destruction of platelets in ITP.
How Is Wayrilz Taken?
The FDA-approved dose is:
400 mg by mouth twice daily.
Treatment response is monitored using platelet counts and other clinical factors.
What Did the Clinical Trial Show?
FDA approval was supported by the LUNA-3 trial involving 202 patients with persistent or chronic ITP.
The study evaluated whether Wayrilz could produce and maintain an improvement in platelet counts compared with placebo.
Trial results apply to the population studied and do not guarantee the same response for every patient.
Bottom Line
Wayrilz (rilzabrutinib) is an FDA-approved oral treatment for adults with persistent or chronic ITP who have not responded adequately to previous treatment.
Treatment should be guided by a hematology specialist with appropriate platelet and safety monitoring.
Sources
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Wayrilz.
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2025.