Last reviewed 2026-04-20 · How we verify

Copiktra (DUVELISIB)

Copiktra works by blocking an enzyme that helps cancer cells grow and multiply.

Copiktra (Duvelisib) is a small molecule therapy originally developed by Verastem Inc. and currently owned by Secura. It targets the phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform, a key enzyme involved in cell signaling. Copiktra is FDA-approved for the treatment of chronic lymphocytic leukemia, follicular non-Hodgkin's lymphoma, and small lymphocytic lymphoma. The drug is patented and has not yet gone generic. Key safety considerations include monitoring for infections and cytopenias.

At a glance

Mechanism of action

Duvelisib is an inhibitor of PI3K with inhibitory activity predominantly against PI3K- and PI3K- 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 cell-signaling pathways, including B-cell receptor signaling and CXCR12-mediated chemotaxis of malignant B-cells. Additionally, duvelisib inhibits CXCL12-induced cell migration and M-CSF and IL-4 driven M2 polarization of macrophages.

Approved indications

• Chronic lymphoid leukemia, disease
• Follicular non-Hodgkin's lymphoma
• Malignant lymphoma - small lymphocytic

Boxed warnings

• 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 )

Common side effects

• Diarrhea or colitis
• Neutropenia
• Rash
• Fatigue
• Pyrexia
• Cough
• Nausea
• Upper respiratory infection
• Pneumonia
• Musculoskeletal pain
• Anemia
• Thrombocytopenia

Key clinical trials

• Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome (PHASE1)
• Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS (PHASE1,PHASE2)
• A Phase 1b/2 Study of IPI-145 Plus FCR in Previously Untreated, Younger Patients With CLL (PHASE1,PHASE2)
• A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype (PHASE3)
• Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma (PHASE2)
• Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy (PHASE1)
• Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (PHASE2)
• Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas (PHASE2)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Copiktra CI brief — competitive landscape report
• Copiktra updates RSS · CI watch RSS
• Secura portfolio CI