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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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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
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
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
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bortezomibANDA2025-11-20
boruzuNew Drug Application2025-07-05
velcadeNew Drug Application2025-08-28
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
1071 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—C90.0—22——4
Plasma cell neoplasmsD054219———12——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.911———2
Non-hodgkin lymphomaD008228—C85.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C951————1
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.01————1
Lymphoid leukemiaD007945—C911————1
Mantle-cell lymphomaD020522—C83.11————1
NeoplasmsD009369—C801————1
Indications Without Phase
No data
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
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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
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
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 46,890 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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67,201 adverse events reported
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