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Velcade(bortezomib)
Velcade (bortezomib) is a small molecule pharmaceutical. Bortezomib was first approved as Velcade on 2003-05-13. It is used to treat mantle-cell lymphoma and multiple myeloma in the USA. It has been approved in Europe to treat multiple myeloma. The pharmaceutical is active against proteasome subunit beta type-5. In addition, it is known to target proteasome subunit beta type-1.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Velcade (generic drugs available since 2022-05-02)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bortezomib
Tradename
Company
Number
Date
Products
BORTEZOMIBACCORD HLTHCAREN-215441 PEND2022-07-26
2 products, RLD
BORTEZOMIBHospiraN-209191 RX2022-05-02
2 products, RLD, RS
BORTEZOMIBMAIA BiotechnologyN-215331 PEND2022-07-27
2 products, RLD
VELCADETakedaN-021602 RX2003-05-13
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bortezomibANDA2022-06-01
velcadeNew Drug Application2020-05-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mantle-cell lymphoma—D020522C83.1
multiple myeloma—D009101C90.0
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Bortezomib, Bortezomib, Fresenius Kabi Usa
89625722032-11-03DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XG: Proteasome inhibitors, antineoplastic agent
— L01XG01: Bortezomib
HCPCS
Code
Description
J9041
Injection, bortezomib (velcade), 0.1 mg
J9044
Injection, bortezomib, not otherwise specified, 0.1 mg
Clinical
Clinical Trials
864 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101C90.010921287925388
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0141341231
Waldenstrom macroglobulinemiaD008258C88.081611125
Hematologic neoplasmsD01933754—1310
Kidney transplantationD0160302311—5
Chronic renal insufficiencyD051436N18—1—1—2
Iga glomerulonephritisD005922EFO_0004194———112
Glycogen storage disease type iiD006009Orphanet_365E74.02———1—1
ProteinuriaD011507HP_0000093R80———1—1
Lupus nephritisD008181EFO_0005761———1—1
Show 3 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mantle-cell lymphomaD020522C83.121323—148
LymphomaD008223C85.921291—147
Non-hodgkin lymphomaD008228C85.920191—136
Myeloid leukemia acuteD015470C92.015101—124
Large b-cell lymphoma diffuseD016403C83.310111—121
LeukemiaD007938C951181——18
AmyloidosisD000686EFO_1001875E85162—311
Immunoglobulin light-chain amyloidosisD000075363244——10
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3—11——2
CholangiocarcinomaD018281C22.1——1——1
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80419———45
Follicular lymphomaD008224C821018——227
Plasma cell neoplasmsD0542191315———24
Non-small-cell lung carcinomaD002289716———21
Myelodysplastic syndromesD009190D46107——117
B-cell chronic lymphocytic leukemiaD015451C91.1105——115
Hodgkin diseaseD006689C8175———12
Breast neoplasmsD001943EFO_0003869C5075———11
B-cell lymphoma marginal zoneD018442C88.464——111
Lung neoplasmsD008175C34.9086———11
Show 103 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Large-cell lymphoma anaplasticD017728C84.65————5
Lymphomatoid granulomatosisD008230C83.84———15
Large-cell lymphoma immunoblasticD0164003———14
Fallopian tube neoplasmsD0051853————3
AnemiaD000740EFO_0004272D64.92————2
Intraocular lymphomaD0640901———12
AstrocytomaD001254EFO_00002712————2
OligodendrogliomaD009837EFO_00006312————2
Castration-resistant prostatic neoplasmsD0641291————1
Myelomonocytic leukemia chronicD015477C93.11————1
Show 32 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hairy cell leukemiaD007943C91.4————11
Systolic heart failureD054143EFO_1001207I50.20————11
Hemoglobin sc diseaseD006450EFO_1001797D57.2————11
GlomerulonephritisD005921N05————11
Membranoproliferative glomerulonephritisD015432————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBORTEZOMIB
INNbortezomib
Description
Bortezomib is l-Phenylalaninamide substituted at the amide nitrogen by a 1-(dihydroxyboranyl)-3-methylbutyl group and at N(alpha) by a pyrazin-2-ylcarbonyl group. It is a dipeptidyl boronic acid that reversibly inhibits the 26S proteasome. It has a role as an antineoplastic agent, a proteasome inhibitor, a protease inhibitor and an antiprotozoal drug. It is an amino acid amide, a member of pyrazines and a L-phenylalanine derivative. It is functionally related to a boronic acid.
Classification
Small molecule
Drug classproteozome inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O
Identifiers
PDB5L5F
CAS-ID179324-69-7
RxCUI358258
ChEMBL IDCHEMBL325041
ChEBI ID52717
PubChem CID387447
DrugBankDB00188
UNII ID69G8BD63PP (ChemIDplus, GSRS)
Target
Agency Approved
PSMB5
PSMB5
Organism
Homo sapiens
Gene name
PSMB5
Gene synonyms
LMPX, MB1, X
NCBI Gene ID
5693
Protein name
proteasome subunit beta type-5
Protein synonyms
Macropain epsilon chain, Multicatalytic endopeptidase complex epsilon chain, proteasome (prosome, macropain) subunit, beta type, 5, proteasome beta 5 subunit, proteasome catalytic subunit 3, Proteasome chain 6, Proteasome epsilon chain, proteasome subunit beta 5, Proteasome subunit MB1, Proteasome subunit X, proteasome subunit, beta type, 5, PSX large multifunctional protease X, testicular tissue protein Li 153
Uniprot ID
P28074
Mouse ortholog
Psmb5 (19173)
proteasome subunit beta type-5 (Q9R1P2)
Alternate
PSMB1
PSMB1
Organism
Homo sapiens
Gene name
PSMB1
Gene synonyms
PSC5
NCBI Gene ID
5689
Protein name
proteasome subunit beta type-1
Protein synonyms
Macropain subunit C5, Multicatalytic endopeptidase complex subunit C5, proteasome (prosome, macropain) subunit, beta type, 1, proteasome beta 1 subunit, Proteasome component C5, Proteasome gamma chain, proteasome subunit beta 1, proteasome subunit beta6, proteasome subunit HC5, testicular secretory protein Li 45
Uniprot ID
Q9BWA8
Mouse ortholog
Psmb1 (19170)
proteasome subunit beta type-1 (Q62039)
Variants
Clinical Variant
No data
Financial
Velcade - Takeda
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Velcade - Johnson & Johnson
$
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£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 35,600 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,953 adverse events reported
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