COPIKTRA (duvelisib)
Copiktra helps adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma when their cancer has returned or failed to respond to previous therapies. It is used specifically for those who have already undergone at least two prior rounds of systemic treatment. This medication is not used as an initial or second-line therapy because of risks associated with treatment-related mortality.
How COPIKTRA Works
This drug works by blocking PI3K, specifically targeting the delta and gamma isoforms found in both healthy and cancerous B-cells. By inhibiting these signaling pathways, it reduces the viability of tumor cells and prevents them from growing. It also disrupts the movement of malignant cells and certain immune cell processes that support the cancer.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-09-24
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- CAPSULE
COPIKTRA Approval History
What COPIKTRA Treats
2 indicationsCOPIKTRA is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
COPIKTRA Boxed Warning
TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, AND PNEUMONITIS Treatment-related mortality occurred in 15% of COPIKTRA-treated patients [see Warnings and Precautions ( 5.1 )] . Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected [see Warnings and Precautions ( 5.2 )]. Fatal and/or serious diarrhea or colitis occurred in 18% ...
WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, AND PNEUMONITIS Treatment-related mortality occurred in 15% of COPIKTRA-treated patients [see Warnings and Precautions ( 5.1 )] . Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected [see Warnings and Precautions ( 5.2 )]. Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA [see Warnings and Precautions ( 5.3 )] . Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA [see Warnings and Precautions ( 5.4 )] . Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA [see Warnings and Precautions ( 5.5 )]. WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS See full prescribing information for complete boxed warning Treatment-related mortality occurred in 15% of COPIKTRA-treated patients. ( 5.1 ) Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected. ( 5.2 ) Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA. ( 5.3 ) Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA. ( 5.4 ) Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA. ( 5.5 )
COPIKTRA Target & Pathway
ProTarget
A cytokine that promotes Th2 immune responses and IgE production. IL-4 drives allergic inflammation in atopic dermatitis and asthma. Blocking IL-4 (often together with IL-13) reduces the type 2 inflammation underlying these conditions.
COPIKTRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in COPIKTRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications COPIKTRA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to COPIKTRA
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
34 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04652960 | NCI-2020-11641 NCI-2020-11641, 10347 | Ph 1 | active not recruiting | Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome |
| NCT04803201 | A051902 NCI-2021-01380, U10CA180821 | Ph 2 | suspended | Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma |
| NCT04331119 | 202005165 | Ph 2 | terminated | Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas |
| NCT02783625 | 16-042 | Ph 1 | completed | Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas |
| NCT05010005 | 21-176 | Ph 1 | recruiting | A Study of Ruxolitinib and Duvelisib in People With Lymphoma |
| NCT07001384 | 25-056 | Ph 1 | recruiting | A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL) |
| NCT06522737 TERZO | SBI-0145-304 2024-516605-23-00 | Ph 3 | recruiting | A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype |
| NCT03534323 results posted | 18-089 | Ph 1, Ph 2 | active not recruiting | Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS |
| NCT05044039 | 202111018 5R35CA210084 | Ph 1 | active not recruiting | Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy |
| NCT03961672 results posted | 19563 NCI-2019-02789, HEM-19009-LM | Ph 2 | active not recruiting | Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT07293403 | 25403 NCI-2025-09029, 25403 | Ph 2 | not yet recruiting | Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas |
| NCT04688658 results posted | HCC 20-155 | Ph 1, Ph 2 | terminated | Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable Melanoma |
| NCT05065866 | MCC-21096 | Ph 1 | completed | Duvelisib in Combination With BMS-986345 in Lymphoid Malignancy |
| NCT05057247 results posted | 21-393 | Ph 2 | completed | Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC |
| NCT06810778 | 24-001373 NCI-2025-00574 | Ph 1, Ph 2 | recruiting | Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) |
| NCT03372057 PRIMO results posted | VS-0145-225 2019-001123-13 | Ph 2 | completed | A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) |
| NCT04038359 TEMPO results posted | VS-0145-229 2019-001381-14 | Ph 2 | completed | A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma |
| NCT03892044 | OSU-18173 NCI-2019-01028 | Ph 1 | completed | Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma |
| NCT02391545 results posted | IPI-145-19 2014-005459-13 | Ph 1, Ph 2 | terminated | A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO) |
| NCT02204982 DYNAMO + R results posted | IPI-145-08 2013-002406-31 | Ph 3 | terminated | Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma |
| NCT04193293 results posted | VS-0145-130 | Ph 1, Ph 2 | terminated | A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer |
| NCT02004522 results posted | IPI-145-07 2013-002405-61 | Ph 3 | completed | A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO) |
| NCT02711852 results posted | IPI-145-23 | Ph 2 | completed | A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145) |
| NCT01882803 DYNAMO results posted | IPI-145-06 2013-004008-20 | Ph 2 | completed | A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma |
| NCT04487886 DAMPEN-CI results posted | STUDY00000701 | Ph 2 | completed | Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19) |
| NCT04372602 results posted | 202007009 | Ph 2 | completed | Duvelisib to Combat COVID-19 |
| NCT03370185 BRIO | VS-0145-224 | Ph 2 | withdrawn | Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma |
| NCT04639843 | 200169 20-C-0169 | Ph 1 | withdrawn | Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma |
| NCT04836832 | OSU-20179 NCI-2021-01355 | Ph 1 | withdrawn | Acalabrutinib and Duvelisib for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin Lymphoma |
| NCT04209621 results posted | 200016 20-H-0016 | Ph 2 | terminated | Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| NCT02605694 | IPI-145-21 2015-004729-15 | Ph 2 | withdrawn | Duvelisib With Rituximab vs R-CHOP in Subjects With Relapsed/Refractory Follicular Lymphoma (FRESCO) |
| NCT02576275 | IPI-145-22 | Ph 3 | withdrawn | A Study of Duvelisib in Combination With Rituximab and Bendamustine vs Placebo in Combination With Rituximab and Bendamustine in Subjects With Previously-Treated Indolent Non-Hodgkin Lymphoma (BRAVURA) |
| NCT02598570 | M15-460 | Ph 1 | completed | Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma |
| NCT02640833 | M15-330 2015-003302-16 | Ph 1 | withdrawn | A Study of Duvelisib and Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Indolent or Aggressive Non-Hodgkin Lymphoma, Who Have Not Previously Received a Bcl-2 or PI3K Inhibitor |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
COPIKTRA FDA Label Details
Indications & Usage
FDA Label (PDF)COPIKTRA is indicated for the treatment of Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma.
WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, AND PNEUMONITIS Treatment-related mortality occurred in 15% of COPIKTRA-treated patients [see Warnings and Precautions ( 5.1 )] . Fatal and/or serious infections occurred in 31% of COPI...
COPIKTRA Patents & Exclusivity
Patents (6 active)
Pro Intelligence Preview
Deep insights for COPIKTRA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 32 active patents
Trial Analysis
- • 36 total trials
- • Stage: Stable
Competitive Landscape
- • 16 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment