NDAORALTABLET
Approved
Aug 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
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 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WAYRILZ (rilzabrutinib) is an oral Bruton's Tyrosine Kinase (BTK) inhibitor approved by the FDA on August 29, 2025. It is a small-molecule kinase inhibitor designed to selectively target BTK-mediated signaling pathways. The drug treats immune-mediated conditions by modulating B-cell and innate immune cell activation.
Growth14.3 years to LOE
Early-stage growth product with established commercial infrastructure at Sanofi; team expansion expected as market adoption accelerates.
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 (20)
An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Inhibition
Started Oct 2026
14 enrolled
Healthy Volunteer
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
Started Sep 2026
16 enrolled
Renal ImpairmentHealthy Volunteers
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
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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.