NDAORALTABLET
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
18
Data completeness
6/8 — Strong
WAYRILZ (rilzabrutinib) by Sanofi is bruton's tyrosine kinase inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2025.
Drug data last refreshed 2d ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WAYRILZ (rilzabrutinib) is an oral small-molecule Bruton's Tyrosine Kinase (BTK) inhibitor approved by the FDA on August 29, 2025. It selectively inhibits BTK signaling to modulate B-cell and myeloid cell activation. The drug treats conditions driven by BTK-dependent immune dysregulation.
Growth14.7 years to LOE
Early-stage launch product with modest team size (2 linked roles); significant upside potential in competitive kinase inhibitor market.
Mechanism of Action
Bruton's Tyrosine Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
Started Oct 2025
60 enrolled
Immune Thrombocytopenia
Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan
Started Oct 2025
4 enrolled
Immune Thrombocytopenia
A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
Started Sep 2025
124 enrolled
Immunoglobulin G4 Related Disease
A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
Started Sep 2025
30 enrolled
Graves' Disease
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
Started Aug 2025
90 enrolled
Autoimmune Haemolytic Anaemia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.