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Wayrilz (RILZABRUTINIB)
Wayrilz works by blocking a specific enzyme that helps platelet-destroying immune cells function.
At a glance
| Generic name | RILZABRUTINIB |
|---|---|
| Sponsor | Genzyme Corp |
| Drug class | Kinase Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Rilzabrutinib is a small-molecule, covalent, reversible kinase inhibitor targeting Bruton's tyrosine kinase (BTK). Rilzabrutinib mediates its therapeutic effect in ITP through immune modulation including 1) inhibition of B cell activation, and 2) interruption of antibody-coated cell phagocytosis by Fcγ receptor (FcγR) in spleen and liver. In vitro , rilzabrutinib reduced autoantibody signaling mediated through the FcγR pathway, blocked B cell signaling, and decreased autoantibody generation through effects on B cell activation.
Approved indications
- persistent or chronic immune thrombocytopenia (ITP)
Common side effects
- Diarrhea
- Nausea
- Headache
- Abdominal Pain Grouped term
- COVID-19
- Arthralgia
- Dizziness
- Nasopharyngitis
- Vomiting
- Dyspepsia
- Cough
Drug interactions
- CYP3A Inhibitors
- CYP3A Inducers
- Grapefruit
- Starfruit
- Seville Oranges
- Proton Pump Inhibitors
- Antacids
- H2 Receptor Antagonists
- CYP3A Substrates
- P-gp Substrates
- BCRP Substrates
- OATP1B Substrates
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease (PHASE2)
- A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease (PHASE3)
- A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease (PHASE2)
- The Efficacy and Safety of Rilzabrutinib in Patients Aged 10 to 65 Years With Sickle-cell Disease (PHASE3)
- Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment (PHASE3)
- A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia (PHASE3)
- Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP) (PHASE3)
- A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP) (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Wayrilz CI brief — competitive landscape report
- Wayrilz updates RSS · CI watch RSS
- Genzyme Corp portfolio CI