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Drug ReportsBortezomib
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.
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Events Timeline
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3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Results first post date
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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
bortezomibANDA2023-12-29
velcadeNew Drug Application2022-10-25
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, Maia Pharms Inc
116791192042-09-23U-3632, U-3633
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
1027 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 myelomaD009101—C90.0134268971454499
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.0141341332
Waldenstrom macroglobulinemiaD008258HP_0005508C88.081611125
Immunoglobulin light-chain amyloidosisD000075363——2461114
Hematologic neoplasmsD019337——65—2312
Kidney transplantationD016030——2311—5
Chronic renal insufficiencyD051436—N18—1—1—2
Residual neoplasmD018365—————112
Iga glomerulonephritisD005922EFO_0004194————112
Healthy volunteers/patients——————1—1
Show 9 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mantle-cell lymphomaD020522—C83.121372—254
LymphomaD008223—C85.922301—149
Non-hodgkin lymphomaD008228—C85.920191—237
Myeloid leukemia acuteD015470—C92.015101—225
Large b-cell lymphoma diffuseD016403—C83.310122—122
LeukemiaD007938—C951181——18
AmyloidosisD000686EFO_1001875E85184—415
Peripheral nervous system diseasesD010523HP_0009830G64—21—36
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3—11——2
Chronic kidney failureD007676EFO_0003884N18.6—11——2
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C804511——152
Follicular lymphomaD008224—C821018——227
Plasma cell neoplasmsD054219——1316———25
Non-small-cell lung carcinomaD002289——716———21
Myelodysplastic syndromesD009190—D46118——118
B-cell chronic lymphocytic leukemiaD015451—C91.1105——216
Breast neoplasmsD001943EFO_0003869C5075——112
Hodgkin diseaseD006689—C8175———12
B-cell lymphoma marginal zoneD018442—C88.464——111
Lung neoplasmsD008175HP_0100526C34.9086———11
Show 105 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Large-cell lymphoma anaplasticD017728—C84.65————5
Lymphomatoid granulomatosisD008230—C83.84———15
Large-cell lymphoma immunoblasticD016400——3———14
Fallopian tube neoplasmsD005185——3————3
AnemiaD000740HP_0001903D64.92————2
Intraocular lymphomaD064090——1———12
AstrocytomaD001254EFO_0000271—2————2
OligodendrogliomaD009837EFO_0000631—2————2
Castration-resistant prostatic neoplasmsD064129——1————1
Myelomonocytic leukemia chronicD015477—C93.11————1
Show 32 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333HP_0001635I50————11
Hairy cell leukemiaD007943—C91.4————11
Systolic heart failureD054143EFO_1001207I50.20————11
Hemoglobin sc diseaseD006450EFO_1001797D57.2————11
GlomerulonephritisD005921HP_0000099N05————11
Membranoproliferative glomerulonephritisD015432——————11
SurvivorshipD000073859——————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)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O
Identifiers
PDB—
CAS-ID179324-69-7
RxCUI—
ChEMBL IDCHEMBL325041
ChEBI ID52717
PubChem CID387447
DrugBankDB00188
UNII ID69G8BD63PP (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
PSMB1
PSMB1
Organism
Homo sapiens
Gene name
PSMB1
Gene synonyms
PSC5
NCBI Gene ID
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
Mouse ortholog
Psmb1 (19170)
proteasome subunit beta type-1 (Q62039)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Velcade – Takeda
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Velcade – Johnson & Johnson
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 39,453 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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47,551 adverse events reported
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