COPIKTRA

This brand name is authorized in Estonia, Ireland, Lithuania, Poland, United States

Active ingredients

The drug COPIKTRA contains one active pharmaceutical ingredient (API):

1 Duvelisib
UNII 610V23S0JI - DUVELISIB

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

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
COPIKTRA Capsule FDA, National Drug Code (US) MPI, US: SPL/PLR
COPIKTRA Hard capsule European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
L01EM04 L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EM Phosphatidylinositol-3-kinase (Pi3K) inhibitors
Discover more medicines within L01EM04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: EE Ravimiamet Identifier(s): 1849305, 1849316
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1092668, 1092669
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100455394, 100455407
Country: US FDA, National Drug Code Identifier(s): 71779-115, 71779-125

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