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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
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
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
COPIKTRASecura BioN-211155 RX2018-09-24
2 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
copiktraNew Drug Application2019-08-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
b-cell chronic lymphocytic leukemia—D015451C91.1
Agency Specific
FDA
EMA
Expiration
Code
DUVELISIB, COPIKTRA, SECURA
2025-09-24ODE-208
2023-09-24NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Duvelisib, Copiktra, Secura
RE466212032-05-17DS, DP
98405052032-01-10U-2412, U-2413
113127182032-01-10DP
81931822030-02-13DP
92169822029-01-05U-2412, U-2413
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EM: Phosphatidylinositol-3-kinase (pi3k) inhibitors
— L01EM04: Duvelisib
HCPCS
No data
Clinical
Clinical Trials
32 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.01081——13
Myelodysplastic syndromesD009190D46791——12
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—21——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelomonocytic leukemia chronicD015477C93.153———7
Biphenotypic leukemia acuteD015456C95.0—1———1
Myeloid leukemia chronic-phaseD015466—1———1
Philadelphia chromosomeD010677—1———1
MelanomaD00854511———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematopoietic stem cell transplantationD0183801————1
NeoplasmsD009369C801————1
T-cell leukemiaD0154581————1
Healthy volunteers/patients—1————1
Prostatic neoplasmsD011471C611————1
Castration-resistant prostatic neoplasmsD0641291————1
Non-hodgkin lymphomaD008228C85.91————1
Hodgkin diseaseD006689C811————1
Large b-cell lymphoma diffuseD016403C83.31————1
Breast neoplasmsD001943EFO_0003869C501————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 nameDUVELISIB
INNduvelisib
Description
8-chloro-2-phenyl-3-[(1S)-1-(7H-purin-6-ylamino)ethyl]-1-isoquinolinone is a member of isoquinolines.
Classification
Small molecule
Drug classphosphatidylinositol 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-ID1201438-56-3
RxCUI—
ChEMBL IDCHEMBL3039502
ChEBI ID—
PubChem CID50905713
DrugBankDB11952
UNII ID610V23S0JI (ChemIDplus, GSRS)
Target
Agency Approved
PIK3CG
PIK3CG
PIK3CD
PIK3CD
Organism
Homo sapiens
Gene name
PIK3CG
Gene synonyms
NCBI Gene ID
5294
Protein name
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform
Protein synonyms
1-phosphatidylinositol 3-kinase, p110gamma, p120-PI3K, phosphatidylinositol 3 kinase gamma, p110 gamma, phosphatidylinositol 3-kinase catalytic 110-kD gamma, Phosphatidylinositol 4,5-bisphosphate 3-kinase 110 kDa catalytic subunit gamma, phosphatidylinositol-4,5-bisphosphate 3-kinase 110 kDa catalytic subunit gamma, Phosphoinositide-3-kinase catalytic gamma polypeptide, phosphoinositide-3-kinase gamma catalytic subunit, PI3-kinase subunit gamma, ptdIns-3-kinase subunit gamma, PtdIns-3-kinase subunit p110-gamma, Serine/threonine protein kinase PIK3CG
Uniprot ID
Q9BZC8
Mouse ortholog
Pik3cg (30955)
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform (Q9JHG7)
Alternate
PIK3CB
PIK3CB
PIK3CA
PIK3CA
Organism
Homo sapiens
Gene name
PIK3CB
Gene synonyms
PIK3C1
NCBI Gene ID
5291
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
Q24JU2
Mouse ortholog
Pik3cb (74769)
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform (Q8BTI9)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 972 documents
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Safety
Black-box Warning
Black-box warning for: Copiktra
Adverse Events
Top Adverse Reactions
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270 adverse events reported
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