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
Therapeutic Areas
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bortezomib | ANDA | 2024-12-05 |
| boruzu | New Drug Application | 2024-09-27 |
| velcade | New Drug Application | 2022-10-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple myeloma | — | D009101 | C90.0 |
| mantle-cell lymphoma | — | D020522 | — |
Agency Specific
FDA
EMA
No data
Clinical
Clinical Trials
1046 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 myeloma | D009101 | — | C90.0 | 156 | 303 | 103 | 14 | 65 | 565 |
| Plasma cell neoplasms | D054219 | — | — | 150 | 287 | 96 | 14 | 55 | 527 |
| Leukemia | D007938 | — | C95 | 42 | 45 | 4 | 1 | 5 | 85 |
| Recurrence | D012008 | — | — | 20 | 24 | 1 | 1 | 2 | 45 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 16 | 18 | 4 | 1 | 3 | 37 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | 3 | 16 | 11 | 1 | 7 | 36 |
| Lymphoid leukemia | D007945 | — | C91 | 12 | 16 | 3 | 1 | 3 | 31 |
| Waldenstrom macroglobulinemia | D008258 | HP_0005508 | C88.0 | 9 | 19 | 1 | 1 | 1 | 28 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | 2 | 9 | 9 | 1 | 4 | 24 |
| Hematologic neoplasms | D019337 | — | — | 7 | 7 | — | 2 | 4 | 16 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 59 | 124 | 9 | — | 4 | 174 |
| Mantle-cell lymphoma | D020522 | — | — | 21 | 44 | 2 | — | 2 | 61 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 26 | 28 | 3 | — | 2 | 52 |
| Plasmacytoma | D010954 | — | C90.3 | 13 | 19 | 1 | — | 1 | 30 |
| B-cell lymphoma | D016393 | — | — | 14 | 18 | 2 | — | 1 | 30 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 19 | 11 | 1 | — | 2 | 29 |
| Myeloid leukemia | D007951 | — | C92 | 17 | 12 | 1 | — | 2 | 29 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 11 | 16 | 2 | — | 1 | 27 |
| Peripheral nervous system diseases | D010523 | HP_0009830 | G64 | — | 4 | 1 | — | 12 | 17 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | 6 | 1 | — | — | 8 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 51 | 15 | — | — | 1 | 60 |
| Follicular lymphoma | D008224 | — | C82 | 11 | 24 | — | — | 2 | 33 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 15 | 20 | — | — | — | 30 |
| Non-small-cell lung carcinoma | D002289 | — | — | 8 | 18 | — | — | — | 23 |
| Myelodysplastic syndromes | D009190 | — | D46 | 12 | 11 | — | — | 1 | 22 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 11 | 5 | — | — | 2 | 17 |
| T-cell lymphoma | D016399 | — | — | 8 | 11 | — | — | — | 17 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 9 | 8 | — | — | 2 | 17 |
| Carcinoma | D002277 | — | C80.0 | 4 | 11 | — | — | — | 15 |
| Preleukemia | D011289 | — | — | 10 | 5 | — | — | 1 | 15 |
Show 156 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphomatoid granulomatosis | D008230 | — | C83.8 | 4 | — | — | — | 1 | 5 |
| Blast crisis | D001752 | — | — | 4 | — | — | — | — | 4 |
| Mycoses | D009181 | — | B35-B49 | 4 | — | — | — | — | 4 |
| Sezary syndrome | D012751 | — | C84.1 | 4 | — | — | — | — | 4 |
| Mycosis fungoides | D009182 | — | C84.0 | 4 | — | — | — | — | 4 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 3 | — | — | — | — | 3 |
| Fallopian tube neoplasms | D005185 | — | — | 3 | — | — | — | — | 3 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 2 | — | — | — | — | 2 |
| Intraocular lymphoma | D064090 | — | — | 1 | — | — | — | 1 | 2 |
| Astrocytoma | D001254 | EFO_0000271 | — | 2 | — | — | — | — | 2 |
Show 42 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | — | — | 1 | 1 |
| Abnormal karyotype | D059786 | — | — | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Hairy cell leukemia | D007943 | — | C91.4 | — | — | — | — | 1 | 1 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | — | — | 1 | 1 |
| Hemoglobin sc disease | D006450 | EFO_1001797 | D57.2 | — | — | — | — | 1 | 1 |
| Hemoglobin c disease | D006445 | — | D58.2 | — | — | — | — | 1 | 1 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | — | 1 | 1 |
| Glomerulonephritis | D005921 | HP_0000099 | N05 | — | — | — | — | 1 | 1 |
| Membranoproliferative glomerulonephritis | D015432 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Bortezomib |
| INN | bortezomib |
| 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 class | proteozome 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
| PDB | — |
| CAS-ID | 179324-69-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL325041 |
| ChEBI ID | 52717 |
| PubChem CID | 387447 |
| DrugBank | DB00188 |
| UNII ID | 69G8BD63PP (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
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Velcade – Takeda
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Velcade – Johnson & Johnson
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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64,236 adverse events reported
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