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 13h ago · AI intelligence enriched 3d 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 and mantle cell lymphoma. It works by irreversibly binding and inhibiting BTK, a key signaling protein in B-cell malignancies. The drug represents a foundational kinase inhibitor class in oncology.
$2.4BPart D
Peak8.6 years to LOEPeak-stage asset generating $2.4B in Part D spending with 152K annual claims, indicating mature commercial infrastructure and stable large team engagement.
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)
A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS
Started Mar 2027
20 enrolled
Multiple Sclerosis (MS) - Relapsing-remittingMultiple Sclerosis (MS) Secondary ProgressiveMultiple Sclerosis (MS) Primary Progressive
Epcoritamab Plus Venetoclax Plus Ibrutinib in Patients With Chronic Lymphocytic Leukemia With TP53 Alterations
Started Dec 2026
44 enrolled
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks
Started Nov 2026
382 enrolled
Chronic Spontaneous Urticaria
A Study to Evaluate Efficacy, Safety, and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
Started Oct 2026
180 enrolled
Chronic Pruritus of Unknown Origin
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
Started Aug 2026
576 enrolled
IgE-Mediated Food AllergyPeanut AllergyCow Milk Allergy+1 more
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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.