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Drug ReportsBortezomib
Velcade(bortezomib)
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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Financial
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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
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Primary completion date
Completion date
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
Bortezomib, Velcade (discontinued: Bortezomib)
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
BORTEZOMIBHospiraN-209191 RX2022-05-02
2 products, RLD, RS
BORTEZOMIBShilpa MedicareN-212782 RX2024-08-26
1 products, RLD, RS
VELCADETakedaN-021602 RX2003-05-13
1 products, RLD, RS
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Labels
FDA
EMA
Brand Name
Status
Last Update
bortezomibANDA2024-12-05
boruzuNew Drug Application2024-09-27
velcadeNew Drug Application2022-10-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
multiple myeloma—D009101C90.0
mantle-cell lymphoma—D020522C83.1
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
1052 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
Multiple myelomaD009101—C90.082720—255
Plasma cell neoplasmsD054219——72620—152
LymphomaD008223—C85.9182——11
Mantle-cell lymphomaD020522—C83.1—31——4
AmyloidosisD000686EFO_1001875E85121——3
Non-hodgkin lymphomaD008228—C85.92—1——3
B-cell lymphomaD016393———11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437—N1911———2
Follicular lymphomaD008224—C82—2———2
Non-small-cell lung carcinomaD002289———2———2
Smoldering multiple myelomaD000075122———1———1
Residual neoplasmD018365———1———1
Waldenstrom macroglobulinemiaD008258—C88.0—1———1
Large b-cell lymphoma diffuseD016403—C83.3—1———1
Myelodysplastic syndromesD009190—D4611———1
PreleukemiaD011289——11———1
SyndromeD013577——11———1
Show 6 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C801————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD019337——————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 43,410 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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64,307 adverse events reported
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