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. First approved in 2018.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COPIKTRA (duvelisib) is an oral PI3K inhibitor with selective activity against PI3K-δ and PI3K-γ isoforms expressed in malignant B-cells, approved in September 2018. It inhibits B-cell receptor signaling, CXCR12-mediated chemotaxis, and macrophage polarization to suppress growth of hematologic malignancies. The drug is indicated for relapsed/refractory hematologic cancers, primarily chronic lymphocytic leukemia and follicular lymphoma.
$0.021BPart D
Peak8.8 years to LOEProduct is at peak commercial maturity with modest Part D claims (679 in 2023), suggesting a focused label with limited expansion potential and smaller commercial footprint relative to blockbuster PI3K inhibitors.
Mechanism 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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)
Started Aug 2025
30 enrolled
Anaplastic Lymphoma KinaseAnaplastic Large Cell Lymphoma
Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS Study
Started Jan 2022
4 enrolled
Recurrent Diffuse Large B-Cell LymphomaRefractory Diffuse Large B-Cell Lymphoma
Duvelisib in Combination With BMS-986345 in Lymphoid Malignancy
Started Nov 2021
14 enrolled
Non Hodgkin LymphomaHodgkin LymphomaMyeloma+1 more
Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC
Started Oct 2021
26 enrolled
Squamous Cell Carcinoma of the Head and Neck (SCCHN)Recurrent Squamous Cell Carcinoma of the Head and NeckMetastatic Head and Neck Cancer+2 more
Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
Started Oct 2021
170 enrolled
Angioimmunoblastic T-cell LymphomaEnteropathy-Associated T-Cell LymphomaFollicular T-Cell Lymphoma+4 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.