Vinorelbine
Navelbine (vinorelbine) is a small molecule pharmaceutical. Vinorelbine was first approved as Navelbine on 1994-12-23. It is used to treat breast neoplasms, hodgkin disease, non-small-cell lung carcinoma, and ovarian neoplasms in the USA.
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Trade Name
FDA
EMA
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Vinorelbine tartrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NAVELBINE | Laboratoires Pierre Fabre | N-020388 DISCN | 1994-12-23 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| vinorelbine | ANDA | 2022-05-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| hodgkin disease | — | D006689 | C81 |
| non-small-cell lung carcinoma | — | D002289 | — |
| ovarian neoplasms | EFO_0003893 | D010051 | C56 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9390 | Injection, vinorelbine tartrate, 10 mg |
Clinical
Clinical Trials
898 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 45 | 75 | 36 | 19 | 8 | 163 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 30 | 48 | 18 | 2 | 1 | 80 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 19 | 27 | 10 | 1 | 2 | 52 | |
| Follicular lymphoma | D008224 | C82 | 13 | 12 | 8 | 1 | — | 26 | |
| Mantle-cell lymphoma | D020522 | C83.1 | 6 | 13 | 4 | 1 | — | 20 | |
| Burkitt lymphoma | D002051 | C83.7 | 10 | 10 | — | 2 | — | 19 | |
| Neoplasms | D009369 | C80 | 9 | 4 | 1 | 1 | — | 14 | |
| Large-cell lymphoma anaplastic | D017728 | C84.6 | 5 | 4 | 1 | 1 | — | 9 | |
| Wilms tumor | D009396 | 2 | 3 | 2 | 1 | — | 7 | ||
| Enteropathy-associated t-cell lymphoma | D058527 | C86.2 | 1 | 3 | — | 1 | — | 4 |
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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 | 22 | 99 | 51 | — | 9 | 170 | |
| Leukemia | D007938 | C95 | 9 | 39 | 30 | — | 5 | 77 | |
| Neuroblastoma | D009447 | EFO_0000621 | 12 | 19 | 13 | — | 3 | 47 | |
| Central nervous system neoplasms | D016543 | 6 | 18 | 13 | — | 5 | 41 | ||
| Sarcoma | D012509 | 5 | 17 | 10 | — | 2 | 34 | ||
| Hodgkin disease | D006689 | C81 | 4 | 12 | 14 | — | 1 | 29 | |
| T-cell lymphoma peripheral | D016411 | C84.9 | 6 | 8 | 5 | — | — | 18 | |
| B-cell lymphoma | D016393 | 11 | 8 | 3 | — | — | 18 | ||
| Retinoblastoma | D012175 | 3 | 9 | 3 | — | 2 | 16 | ||
| Medulloblastoma | D008527 | 3 | 8 | 5 | — | — | 15 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biphenotypic leukemia acute | D015456 | C95.0 | 3 | 5 | — | — | — | 7 | |
| Myelodysplastic syndromes | D009190 | D46 | 4 | 2 | — | — | — | 5 | |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | 4 | 3 | — | — | — | 5 | ||
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 2 | 3 | — | — | — | 5 | |
| Plasmablastic lymphoma | D000069293 | C83.3 | 4 | 2 | — | — | — | 4 | |
| B-cell lymphoma marginal zone | D018442 | C88.4 | 2 | 3 | — | — | — | 4 | |
| Primary effusion lymphoma | D054685 | C83.8 | 3 | 3 | — | — | — | 3 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 2 | — | — | — | 3 |
| Myeloid leukemia chronic-phase | D015466 | — | 2 | — | — | — | 2 | ||
| Adult t-cell leukemia-lymphoma | D015459 | C91.5 | 2 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoid leukemia | D007945 | C91 | 2 | — | — | — | — | 2 | |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 1 | — | — | — | — | 1 |
| Pinealoma | D010871 | 1 | — | — | — | — | 1 | ||
| Neoplasm metastasis | D009362 | EFO_0009708 | 1 | — | — | — | — | 1 | |
| Deltaretrovirus infections | D006800 | EFO_1001303 | 1 | — | — | — | — | 1 | |
| Syndrome | D013577 | 1 | — | — | — | — | 1 | ||
| Composite lymphoma | D058617 | 1 | — | — | — | — | 1 | ||
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | — | — | — | — | 1 |
| Melanoma | D008545 | 1 | — | — | — | — | 1 | ||
| Recurrence | D012008 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vomiting | D014839 | HP_0002013 | R11.1 | — | — | — | — | 2 | 2 |
| Nausea | D009325 | HP_0002018 | R11.0 | — | — | — | — | 1 | 1 |
| Ataxia telangiectasia | D001260 | Orphanet_100 | G11.3 | — | — | — | — | 1 | 1 |
| Ototoxicity | D000081015 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | VINORELBINE |
| INN | vinorelbine |
| Description | Vinorelbine (NVB), sold under the brand name Navelbine among others, is a chemotherapy medication used to treat a number of types of cancer. This includes breast cancer and non-small cell lung cancer. It is given by injection into a vein or by mouth.
|
| Classification | Small molecule |
| Drug class | vinca alkaloids |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCC1=C[C@@H]2CN(C1)Cc1c([nH]c3ccccc13)[C@@](C(=O)OC)(c1cc3c(cc1OC)N(C)[C@H]1[C@@](O)(C(=O)OC)[C@H](OC(C)=O)[C@]4(CC)C=CCN5CC[C@]31[C@@H]54)C2 |
Identifiers
| PDB | — |
| CAS-ID | 71486-22-1 |
| RxCUI | 39541 |
| ChEMBL ID | CHEMBL553025 |
| ChEBI ID | 480999 |
| PubChem CID | 60780 |
| DrugBank | DB00361 |
| UNII ID | Q6C979R91Y (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Vinorelbine
Adverse Events
Top Adverse Reactions
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64,083 adverse events reported
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