COPIKTRA

PeakSM

duvelisib

NDAORALCAPSULEPriority Review
Approved
Sep 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9

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…

Clinical Trials (5)

NCT07001384Phase 1Recruiting

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
NCT04890236Phase 1Completed

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
NCT05065866Phase 1Completed

Duvelisib in Combination With BMS-986345 in Lymphoid Malignancy

Started Nov 2021
NCT05057247Phase 2Completed

Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC

Started Oct 2021
NCT04803201Phase 2Suspended

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

Loss of Exclusivity

LOE Date
Apr 26, 2035
111 months away
Patent Expiry
Apr 26, 2035

Patent Records (5)

Patent #ExpiryTypeUse Code
9216982
Jan 5, 2029
U-2412
8193182
Feb 13, 2030
Substance
11312718
Jan 10, 2032
Product
9840505
Jan 10, 2032
U-2413
RE46621
May 17, 2032
SubstanceProduct