NDAORALCAPSULEPriority Review
Approved
Nov 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority ReviewIRA Negotiated
IMBRUVICA (ibrutinib) by AbbVie is protein kinase inhibitors [moa]. First approved in 2013.
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMBRUVICA (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor approved in 2013 for hematologic malignancies including chronic lymphocytic leukemia, mantle cell lymphoma, and marginal zone lymphoma. It works by irreversibly binding to BTK, disrupting B-cell receptor signaling critical to lymphoid cell proliferation and survival. The drug is administered as an oral capsule and represents a foundational kinase inhibitor in oncology.
$2.4BPart D
Peak8.8 years to LOEPeak-stage franchise with $2.4B in Part D spending and substantial patient reach; mature commercial infrastructure with potential headcount rationalization as IRA pricing pressures intensify.
Mechanism of Action
Protein 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)
Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)
Started Jul 2026
470 enrolled
Chronic Spontaneous Urticaria
A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS
Started Jun 2026
20 enrolled
Multiple Sclerosis (MS) - Relapsing-remittingMultiple Sclerosis (MS) Secondary ProgressiveMultiple Sclerosis (MS) Primary Progressive
A Real-world Study of Ibrutinib and Venetoclax (I+V) First-Line Treatment Given for Fixed-duration of Time in Participants With Chronic Lymphocytic Leukemia
Started May 2026
60 enrolled
Leukemia, Lymphocytic, Chronic, B-Cell
Remibrutinib Open Label Roll-over Post-trial Access Protocol
Started Apr 2026
212 enrolled
Indication of the Parent Protocol
Remibrutinib in Real-world Clinical Practice - a US Sub-study
Started Feb 2026
505 enrolled
Chronic Spontaneous Urticaria
Worked on IMBRUVICA at AbbVie? Share your interview experience or compensation data (+7 days Pro)
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.