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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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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
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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
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
bortezomibANDA2025-09-16
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
1067 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—C90.01573061071666576
Plasma cell neoplasmsD054219——126242791651451
LeukemiaD007938—C95353441368
RecurrenceD012008——203441357
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.0182051339
AmyloidosisD000686EFO_1001875E8521591732
Waldenstrom macroglobulinemiaD008258—C88.092011129
Immunoglobulin light-chain amyloidosisD000075363——2991424
Lymphoid leukemiaD007945—C917731218
Hematologic neoplasmsD019337——77—2517
Show 22 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.9531038—3147
Mantle-cell lymphomaD020522—C83.124472—265
Non-hodgkin lymphomaD008228—C85.926273—251
Myeloid leukemia acuteD015470—C92.021121—231
Large b-cell lymphoma diffuseD016403—C83.313182—230
PlasmacytomaD010954—C90.312192—130
B-cell lymphomaD016393——12152—227
Myeloid leukemiaD007951—C9215101—225
Renal insufficiencyD051437—N19171——9
Hematopoietic stem cell transplantationD018380——231—28
Show 11 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C804814——258
Follicular lymphomaD008224—C821426——236
Non-small-cell lung carcinomaD002289——1219———27
Myelodysplastic syndromesD009190—D461211——122
B-cell chronic lymphocytic leukemiaD015451—C91.1146——221
Lung neoplasmsD008175—C34.901114———21
B-cell lymphoma marginal zoneD018442—C88.41010——220
T-cell lymphomaD016399——610———15
Graft vs host diseaseD006086—D89.81712———15
Hodgkin diseaseD006689—C8177———14
Show 155 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lymphomatoid granulomatosisD008230—C83.84———15
Blast crisisD001752——4————4
MycosesD009181—B35-B494————4
AnemiaD000740EFO_0004272D64.92———13
Myeloid leukemia chronic-phaseD015466——3————3
Fallopian tube neoplasmsD005185——3————3
AstrocytomaD001254EFO_0000271—3————3
OligodendrogliomaD009837EFO_0000631—3————3
Myelodysplastic-myeloproliferative diseasesD054437——2————2
Intraocular lymphomaD064090——1———12
Show 44 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cognitive dysfunctionD060825—G31.84————11
Abnormal karyotypeD059786——————11
Heart failureD006333EFO_0003144I50————11
Hairy cell leukemiaD007943—C91.4————11
Systolic heart failureD054143EFO_1001207I50.20————11
Hemoglobin sc diseaseD006450EFO_1001797D57.2————11
Hemoglobin c diseaseD006445—D58.2————11
HypotensionD007022EFO_0005251I95————11
PainD010146EFO_0003843R52————11
GlomerulonephritisD005921—N05————11
Show 6 more
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
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 45,914 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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68,211 adverse events reported
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