NDAORALCAPSULEPriority Review
Approved
Sep 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9
Data completeness
7/8 — Comprehensive
Priority Review
COPIKTRA (duvelisib) by Secura Bio is pi3k with inhibitory activity predominantly against pi3k-δ and pi3k-γ isoforms expressed in normal and malignant b-cells. Approved for chronic lymphocytic leukemia, small lymphocytic lymphoma. First approved in 2018.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COPIKTRA (duvelisib) is an oral PI3K inhibitor with selective activity against PI3K-delta and PI3K-gamma isoforms expressed in B-cells and immune cells. It is approved for refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. The drug works by inhibiting B-cell receptor signaling, CXCR12-mediated chemotaxis, and macrophage polarization pathways. It represents a targeted kinase inhibitor option in the B-cell malignancy market, approved since September 2018.
$0.0BPart D
9.0 years to LOEMechanism of Action
PI3K with inhibitory activity predominantly against PI3K-δ and PI3K-γ isoforms expressed in normal and malignant B-cells. Duvelisib induced growth inhibition and reduced viability in cell lines derived from malignant B-cells and in primary CLL tumor cells. Duvelisib inhibits several key…
Indications (2)
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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.