Independent reference. Not affiliated with, endorsed by, or speaking for the U.S. Food and Drug Administration.
FDA Medication Tracker

← All approvals · Heart & blood · 2025

Wayrilz (rilzabrutinib)

The FDA approved Wayrilz (rilzabrutinib) on August 29, 2025 to treat persistent or chronic immune thrombocytopenia that has not sufficiently responded to immunoglobulins, anti-D therapy, or corticosteroids.
Brand name
Wayrilz
Generic name
rilzabrutinib
FDA approval date
August 29, 2025
Approved use (FDA wording)
To treat persistent or chronic immune thrombocytopenia that has not sufficiently responded to immunoglobulins, anti-D therapy, or corticosteroids
Company
Genzyme Corp
Application
NDA219685
Dosage form / route
TABLET · ORAL
Drug class (EPC)
Kinase Inhibitor [EPC]
Boxed warning on label
Not listed
Category on this site
Heart & blood

Indications and usage, from the FDA label

WAYRILZ is indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. WAYRILZ 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. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.