Treats relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic…. Sold as Copiktra. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Duvelisib (sold as Copiktra), first approved Sep 24, 2018, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Copiktra | Part D | $46.1M | +47% | 302 |
| Program | Updated |
|---|---|
| Copiktra REMSLetters to doctors | Oct 24, 2025 |
| A Study of Topical Duvelisib in Participants With Early-stage Mycosis FungoidesMycosis Fungoides, Cutaneous T-cell Lymphoma · SecuraBio | Phase 1 | Not yet recruiting | Jul 20, 2026 |
| Duvelisib Maintenance for the Treatment of Peripheral T-Cell LymphomasFollicular Helper T-Cell Lymphoma, Peripheral T-Cell Lymphoma, Not Otherwise Specified · City of Hope Medical Center | Phase 2 | Recruiting | Dec 19, 2025 |
| A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)Anaplastic Lymphoma Kinase, Anaplastic Large Cell Lymphoma · Memorial Sloan Kettering Cancer Center | Phase 1 | Recruiting | Jun 3, 2025 |
| Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)T-cell-prolymphocytic Leukemia, Cutaneous T-Cell Lymphoma Refractory · Jonsson Comprehensive Cancer Center | Phase 1 / Phase 2 | Recruiting | Feb 6, 2025 |
| PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell LymphomasLymphoma, T-Cell, NK-LGL Leukemia · Institute of Hematology & Blood Diseases Hospital, China | Phase 2 | Recruiting | Jul 31, 2024 |
| A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) PhenotypeLymphoma · SecuraBio | Phase 3 | Recruiting | Jul 26, 2024 |
| Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)Newly Diagnosed Peripheral T-cell Lymphoma · Liling Zhang | Phase 2 | Recruiting | Aug 4, 2023 |
| (CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma · Ruijin Hospital | — | Not yet recruiting | Jun 28, 2023 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA