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Drug ReportsCopanlisib
Copanlisib
Aliqopa (copanlisib) is a small molecule pharmaceutical. Copanlisib was first approved as Aliqopa on 2017-09-14. It is used to treat follicular lymphoma in the USA. It is known to target phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform, phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform, phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform, serine/threonine-protein kinase mTOR, and phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform.
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Financial
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3M
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FDA approval date
EMA approval date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Copanlisib dihydrochloride
Tradename
Company
Number
Date
Products
ALIQOPABayerN-209936 DISCN2017-09-14
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
aliqopaNew Drug Application2023-09-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
follicular lymphoma—D008224C82
Agency Specific
FDA
EMA
Expiration
Code
COPANLISIB DIHYDROCHLORIDE, ALIQOPA, BAYER HEALTHCARE
2024-09-14ODE-155
Patent Expiration
Patent
Expires
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FDA Information
Copanlisib Dihydrochloride, Aliqopa, Bayer Healthcare
96363442032-03-29U-2124
103838762032-03-29DS, DP
RE468562029-10-22DS, DPU-2124
75110412024-05-13DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EM: Phosphatidylinositol-3-kinase (pi3k) inhibitors
— L01EM02: Copanlisib
HCPCS
Code
Description
J9057
Injection, copanlisib, 1 mg
Clinical
Clinical Trials
76 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
LymphomaD008223—C85.919213—137
Non-hodgkin lymphomaD008228—C85.91053—117
B-cell lymphomaD016393——441——8
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80125——116
CarcinomaD002277—C80.098———13
Breast neoplasmsD001943EFO_0003869C5096———11
RecurrenceD012008——55———9
Large b-cell lymphoma diffuseD016403—C83.345———8
AdenocarcinomaD000230——32———5
Neoplasm metastasisD009362EFO_0009708—51———5
Endometrial neoplasmsD016889EFO_0004230—14———5
Follicular lymphomaD008224—C8223———5
LeukemiaD007938—C9531———4
Show 52 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198——2————2
Hodgkin diseaseD006689—C812————2
Healthy volunteers/patients———2————2
Non-small-cell lung carcinomaD002289——2————2
Myelodysplastic syndromesD009190—D461————1
Myeloid leukemia acuteD015470—C92.01————1
Myeloproliferative disordersD009196—D47.11————1
Primary myelofibrosisD055728—D47.41————1
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—1————1
Myelomonocytic leukemia chronicD015477—C93.11————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 nameCopanlisib
INNcopanlisib
Description
Copanlisib, sold under the brand name Aliqopa, is a medication used for the treatment of adults experiencing relapsed follicular lymphoma who have received at least two prior systemic therapies.
Classification
Small molecule
Drug classphosphatidylinositol 3-kinase (PI3K) inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1c(OCCCN2CCOCC2)ccc2c1N=C(NC(=O)c1cnc(N)nc1)N1CCN=C21
Identifiers
PDB—
CAS-ID1032568-63-0
RxCUI—
ChEMBL IDCHEMBL3218576
ChEBI ID—
PubChem CID24989044
DrugBankDB12483
UNII IDWI6V529FZ9 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
PIK3CD
PIK3CD
PIK3CG
PIK3CG
PIK3CB
PIK3CB
MTOR
MTOR
PIK3CA
PIK3CA
Organism
Homo sapiens
Gene name
PIK3CD
Gene synonyms
NCBI Gene ID
Protein name
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform
Protein synonyms
p110delta, Phosphatidylinositol 4,5-bisphosphate 3-kinase 110 kDa catalytic subunit delta, phosphatidylinositol-4,5-bisphosphate 3-kinase 110 kDa catalytic subunit delta, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit delta short variant 8/20, phosphoinositide-3-kinase C, phosphoinositide-3-kinase, catalytic, delta polypeptide variant p37delta, PI3-kinase p110 subunit delta, PI3Kdelta, PtdIns-3-kinase subunit p110-delta
Uniprot ID
Mouse ortholog
Pik3cd (18707)
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform (Q8CJ28)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,483 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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349 adverse events reported
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