NDAORALSUSPENSIONPriority Review
Approved
Aug 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
IMBRUVICA (ibrutinib) by AbbVie is protein kinase inhibitors [moa]. First approved in 2022.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMBRUVICA (ibrutinib) is an oral protein kinase inhibitor that selectively targets Bruton's tyrosine kinase (BTK), a key driver of B-cell malignancies and autoimmune disorders. The drug is available as a suspension formulation and is currently in peak commercial lifecycle. It represents a foundational small-molecule approach to kinase inhibition in oncology and hematology.
Peak13.0 years to LOE
At peak lifecycle stage with robust patent protection through 2039, this product supports sustained commercial team investment and stable career trajectories in brand management and field operations.
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
Started Feb 2026
3,280 enrolled
Chronic Spontaneous Urticaria
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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.