Copiktra(duvelisib)
Copiktra (duvelisib) is a small molecule pharmaceutical. Duvelisib was first approved as Copiktra on 2018-09-24. It is used to treat b-cell chronic lymphocytic leukemia in the USA. It has been approved in Europe to treat b-cell chronic lymphocytic leukemia and follicular lymphoma. The pharmaceutical is active against phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform and phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform. In addition, it is known to target phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform and phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Copiktra
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Duvelisib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| COPIKTRA | Secura Bio | N-211155 RX | 2018-09-24 | 2 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| copiktra | New Drug Application | 2024-07-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| b-cell chronic lymphocytic leukemia | — | D015451 | C91.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DUVELISIB, COPIKTRA, SECURA | |||
| 2025-09-24 | ODE-208 | ||
HCPCS
No data
Clinical
Clinical Trials
58 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 11 | 13 | 4 | — | 2 | 28 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 7 | 5 | 3 | — | 2 | 15 |
| Leukemia | D007938 | — | C95 | 5 | 7 | 2 | — | 1 | 13 |
| Lymphoid leukemia | D007945 | — | C91 | 6 | 6 | 2 | — | 1 | 13 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 6 | 3 | 1 | — | 2 | 12 |
| Follicular lymphoma | D008224 | — | C82 | 3 | 5 | 2 | — | 2 | 11 |
| T-cell lymphoma peripheral | D016411 | — | — | 5 | 6 | 1 | — | 1 | 11 |
| Recurrence | D012008 | — | — | 2 | 1 | 1 | — | — | 4 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 1 | — | 1 | — | 1 | 3 |
| Immunoblastic lymphadenopathy | D007119 | EFO_1001350 | C86.5 | — | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| T-cell lymphoma | D016399 | — | — | 6 | 7 | — | — | — | 11 |
| Neoplasms | D009369 | — | C80 | 3 | 2 | — | — | — | 4 |
| Hematologic neoplasms | D019337 | — | — | 2 | 1 | — | — | — | 3 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 2 | 1 | — | — | 1 | 3 |
| Enteropathy-associated t-cell lymphoma | D058527 | — | C86.2 | 1 | 1 | — | — | — | 2 |
| Syndrome | D013577 | — | — | 2 | 1 | — | — | — | 2 |
| Head and neck neoplasms | D006258 | — | — | 1 | 2 | — | — | — | 2 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | 2 | — | — | — | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | 2 | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| B-cell lymphoma | D016393 | — | — | 3 | — | — | — | — | 3 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 2 | — | — | — | 1 | 3 |
| Extranodal nk-t-cell lymphoma | D054391 | — | C86.0 | 1 | — | — | — | — | 1 |
| Adult t-cell leukemia-lymphoma | D015459 | — | C91.5 | 1 | — | — | — | — | 1 |
| T-cell leukemia | D015458 | — | — | 1 | — | — | — | — | 1 |
| Sezary syndrome | D012751 | — | C84.1 | 1 | — | — | — | — | 1 |
| Mycosis fungoides | D009182 | — | C84.0 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Duvelisib |
| INN | duvelisib |
| Description | 8-chloro-2-phenyl-3-[(1S)-1-(7H-purin-6-ylamino)ethyl]-1-isoquinolinone is a member of isoquinolines. |
| Classification | Small molecule |
| Drug class | phosphatidylinositol 3-kinase (PI3K) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H](Nc1ncnc2nc[nH]c12)c1cc2cccc(Cl)c2c(=O)n1-c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 1201438-56-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3039502 |
| ChEBI ID | — |
| PubChem CID | 50905713 |
| DrugBank | DB11952 |
| UNII ID | 610V23S0JI (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
PIK3CB
PIK3CB
Organism
Homo sapiens
Gene name
PIK3CB
Gene synonyms
PIK3C1
NCBI Gene ID
Protein name
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform
Protein synonyms
p110beta, Phosphatidylinositol 4,5-bisphosphate 3-kinase 110 kDa catalytic subunit beta, phosphoinositide-3-kinase, catalytic, beta polypeptide, PI3-kinase p110 subunit beta, PI3-kinase subunit beta, PI3K-beta, PtdIns-3-kinase p110, ptdIns-3-kinase subunit beta, PtdIns-3-kinase subunit p110-beta, Serine/threonine protein kinase PIK3CB
Uniprot ID
Mouse ortholog
Pik3cb (74769)
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform (Q8BTI9)
Variants
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Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 1,526 documents
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Safety
Black-box Warning
Black-box warning for: Copiktra
Adverse Events
Top Adverse Reactions
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720 adverse events reported
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