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Calquence(acalabrutinib)
Calquence (acalabrutinib) is a small molecule pharmaceutical. Acalabrutinib was first approved as Calquence on 2017-10-31. It is used to treat mantle-cell lymphoma in the USA. It has been approved in Europe to treat b-cell chronic lymphocytic leukemia. The pharmaceutical is active against tyrosine-protein kinase BTK. In addition, it is known to target tyrosine-protein kinase Fyn, receptor tyrosine-protein kinase erbB-2, epidermal growth factor receptor, tyrosine-protein kinase Blk, tyrosine-protein kinase JAK3, tyrosine-protein kinase ITK/TSK, proto-oncogene tyrosine-protein kinase Src, cytoplasmic tyrosine-protein kinase BMX, tyrosine-protein kinase Tec, tyrosine-protein kinase TXK, tyrosine-protein kinase Lyn, tyrosine-protein kinase Lck, and receptor tyrosine-protein kinase erbB-4.
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COVID-19
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Calquence
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Acalabrutinib
Tradename
Company
Number
Date
Products
CALQUENCEAstraZenecaN-210259 RX2017-10-31
1 products, RLD, RS
Acalabrutinib maleate
Tradename
Company
Number
Date
Products
CALQUENCEAstraZenecaN-216387 RX2022-08-03
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
calquenceNew Drug Application2022-03-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mantle-cell lymphoma—D020522C83.1
Agency Specific
FDA
EMA
Expiration
Code
ACALABRUTINIB, CALQUENCE, ASTRAZENECA
2026-11-21ODE-274
2024-10-31ODE-175
Patent Expiration
Patent
Expires
Flag
FDA Information
Acalabrutinib, Calquence, Astrazeneca
97967212036-07-01DS, DPU-2145, U-2666, U-2667, U-2668, U-2669, U-2670, U-2671
101672912036-07-01DPU-2145, U-2666, U-2667, U-2668, U-2669, U-2670, U-2671
102720832035-01-21U-2519, U-2682, U-2683, U-2684, U-2685, U-2686, U-2687
92905042032-07-11DS, DP
97585242032-07-11U-2145
102398832032-07-11U-2666, U-2668
74595542026-11-24DP
Acalabrutinib Maleate, Calquence, Astrazeneca
110598292036-07-01DS, DPU-2145, U-2666, U-2667, U-2668, U-2669, U-2670, U-2671
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EL: Bruton's tyrosine kinase (btk) inhibitors
— L01EL02: Acalabrutinib
HCPCS
No data
Clinical
Clinical Trials
127 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell chronic lymphocytic leukemiaD015451C91.192881141
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mantle-cell lymphomaD020522C83.16193——25
Large b-cell lymphoma diffuseD016403C83.3391——11
Covid-19D000086382U07.1221—16
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228C85.978———10
Follicular lymphomaD008224C8235———6
Waldenstrom macroglobulinemiaD008258C88.015———5
Reactive arthritisD016918EFO_0007460M02.335———5
Multiple myelomaD009101C90.032———3
LymphomaD008223C85.932———3
Prolymphocytic leukemiaD01546321———2
Pancreatic neoplasmsD010190EFO_0003860C25—2———2
B-cell lymphomaD01639311———1
Rheumatoid arthritisD001172EFO_0000685M06.9—1———1
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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—8————8
Hepatic insufficiencyD0485502————2
Therapeutic equivalencyD0138101————1
Communicable diseasesD0031411————1
PharmacokineticsD0105991————1
Biological availabilityD0016821————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameACALABRUTINIB
INNacalabrutinib
Description
Acalabrutinib is a member of the class of imidazopyrazines that is imidazo[1,5-a]pyrazine substituted by 4-(pyridin-2-ylcarbamoyl)phenyl, (2S)-1-(but-2-ynoyl)pyrrolidin-2-yl, and amino groups at positions 1, 3 and 8, respectively. It is an irreversible second-generation Bruton's tyrosine kinase (BTK) inhibitor that is approved by the FDA for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. It has a role as an EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor, an antineoplastic agent and an apoptosis inducer. It is a secondary carboxamide, a member of benzamides, a member of pyridines, an aromatic amine, a pyrrolidinecarboxamide, an imidazopyrazine, a ynone and a tertiary carboxamide.
Classification
Small molecule
Drug classtyrosine kinase inhibitors: tyrosine kinase inhibitors Bruton's (Btk) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC#CC(=O)N1CCC[C@H]1c1nc(-c2ccc(C(=O)Nc3ccccn3)cc2)c2c(N)nccn12
Identifiers
PDB—
CAS-ID1420477-60-6
RxCUI1986808
ChEMBL IDCHEMBL3707348
ChEBI ID—
PubChem CID71226662
DrugBankDB11703
UNII IDI42748ELQW (ChemIDplus, GSRS)
Target
Agency Approved
BTK
BTK
Organism
Homo sapiens
Gene name
BTK
Gene synonyms
AGMX1, ATK, BPK
NCBI Gene ID
695
Protein name
tyrosine-protein kinase BTK
Protein synonyms
agammaglobulinaemia tyrosine kinase, Agammaglobulinemia tyrosine kinase, ATK, B-cell progenitor kinase, BPK, Bruton agammaglobulinemia tyrosine kinase, Bruton tyrosine kinase, Bruton's tyrosine kinase, dominant-negative kinase-deficient Brutons tyrosine kinase
Uniprot ID
Q32ML5
Mouse ortholog
Btk (12229)
tyrosine-protein kinase BTK (Q61365)
Alternate
FYN
FYN
ERBB2
ERBB2
EGFR
EGFR
BLK
BLK
JAK3
JAK3
ITK
ITK
SRC
SRC
BMX
BMX
TEC
TEC
TXK
TXK
LYN
LYN
LCK
LCK
ERBB4
ERBB4
Organism
Homo sapiens
Gene name
FYN
Gene synonyms
NCBI Gene ID
2534
Protein name
tyrosine-protein kinase Fyn
Protein synonyms
c-syn protooncogene, FYN oncogene related to SRC, FGR, YES, OKT3-induced calcium influx regulator, p59-Fyn, Proto-oncogene c-Fyn, Proto-oncogene Syn, SLK, Src-like kinase, src/yes-related novel, tyrosine kinase p59fyn(T)
Uniprot ID
Q8N5D7
Mouse ortholog
Fyn (14360)
tyrosine-protein kinase Fyn (P39688)
Variants
Clinical Variant
No data
Financial
Calquence - AstraZeneca
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,871 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,354 adverse events reported
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