NDAORALTABLETPriority Review
Approved
Feb 2018
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 2018.
Drug data last refreshed 4h 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 signaling molecule in B-cell malignancies and certain immune conditions. It is a first-in-class BTK inhibitor approved for multiple hematologic malignancies and chronic inflammatory conditions. The drug works by blocking BTK-dependent cell survival and proliferation pathways.
Peak10.2 years to LOE
Peak-lifecycle product with established market position; commercial teams are focused on maintaining market share and optimizing existing indication penetration rather than driving new patient acquisition.
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
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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.