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AboutPricing
Drug ReportsAcalabrutinib
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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Drug
Target
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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
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 Application2024-06-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mantle-cell lymphoma—D020522—
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
117716962035-01-21U-3710
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
172 clinical trials
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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 leukemiaD015451—C91.1210521431
LymphomaD008223—C85.991841228
Lymphoid leukemiaD007945—C9128421327
LeukemiaD007938—C9527521024
Mantle-cell lymphomaD020522——5911—13
Heart failureD006333HP_0001635I50———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell lymphomaD016393——582——11
Large b-cell lymphoma diffuseD016403—C83.3362——9
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.956———7
NeoplasmsD009369—C8043———4
Covid-19D000086382——22———4
Follicular lymphomaD008224—C8213———3
Waldenstrom macroglobulinemiaD008258HP_0005508C88.0—3———3
B-cell lymphoma marginal zoneD018442—C88.4—2———2
Graft vs host diseaseD006086—D89.81—2———2
Bronchiolitis obliterans syndromeD000092122———2———2
Hematologic neoplasmsD019337——12———2
Drug-related side effects and adverse reactionsD064420—T88.7—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Biological availabilityD001682——2————2
Therapeutic equivalencyD013810——1————1
InfectionsD007239EFO_0000544—1————1
Communicable diseasesD003141——1————1
PharmacokineticsD010599——1————1
Liver diseasesD008107HP_0002910K70-K771————1
Liver failureD017093HP_0001399K72.91————1
Hepatic insufficiencyD048550——1————1
Healthy volunteers/patients———1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CardiotoxicityD066126EFO_1001482—————11
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)Loading
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
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
₣
Calquence – AstraZeneca
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,702 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,518 adverse events reported
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