Nexavar(sorafenib)
Nexavar, Sorafenib (sorafenib) is a small molecule pharmaceutical. Sorafenib was first approved as Nexavar on 2005-12-20. It is used to treat hepatocellular carcinoma, renal cell carcinoma, and thyroid neoplasms in the USA. It has been approved in Europe to treat hepatocellular carcinoma and renal cell carcinoma. The pharmaceutical is active against vascular endothelial growth factor receptor 2, mast/stem cell growth factor receptor Kit, and receptor-type tyrosine-protein kinase FLT3. In addition, it is known to target proto-oncogene tyrosine-protein kinase receptor Ret, platelet-derived growth factor receptor beta, vascular endothelial growth factor receptor 3, serine/threonine-protein kinase B-raf, RAF proto-oncogene serine/threonine-protein kinase, fibroblast growth factor receptor 1, cyclin-dependent kinase 8, cyclin-dependent kinase 19, and discoidin domain-containing receptor 2.
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FDA approval date
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Study first post date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Nexavar, Sorafenib (discontinued: Sorafenib)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nexavar | New Drug Application | 2023-08-28 |
| sorafenib | ANDA | 2025-06-19 |
| sorafenib tosylate | ANDA | 2024-07-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| renal cell carcinoma | EFO_0000376 | D002292 | — |
| hepatocellular carcinoma | — | D006528 | C22.0 |
| thyroid neoplasms | EFO_0003841 | D013964 | — |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
868 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 7 | 29 | 12 | 2 | 21 | 70 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 7 | 15 | 6 | 1 | 12 | 39 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 2 | 17 | 6 | 1 | 12 | 38 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 2 | 16 | 6 | 1 | 12 | 37 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 17 | 8 | 2 | — | 1 | 25 |
| Lung neoplasms | D008175 | — | C34.90 | 6 | 9 | 3 | — | — | 17 |
| Non-small-cell lung carcinoma | D002289 | — | — | 7 | 7 | 4 | — | — | 16 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 9 | 1 | — | 1 | 13 |
| Melanoma | D008545 | — | — | 2 | 4 | 1 | — | — | 7 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | 2 | 1 | — | 2 | 5 |
| Thyroid diseases | D013959 | — | E00-E07 | — | 2 | 1 | — | 2 | 5 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 7 | 9 | — | — | — | 11 |
| Myeloid leukemia | D007951 | — | C92 | 5 | 7 | — | — | — | 9 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 5 | 6 | — | — | — | 8 |
| Myelodysplastic syndromes | D009190 | — | D46 | 5 | 6 | — | — | — | 7 |
| Preleukemia | D011289 | — | — | 4 | 5 | — | — | — | 6 |
| Colorectal neoplasms | D015179 | — | — | 3 | 3 | — | — | — | 5 |
| Syndrome | D013577 | — | — | 3 | 4 | — | — | — | 5 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | 3 | — | — | — | 5 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | 3 | — | — | — | 5 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 3 | — | — | — | 4 |
Show 43 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | — | — | — | — | 2 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 1 | — | — | — | — | 1 |
| Digestive system neoplasms | D004067 | — | — | 1 | — | — | — | — | 1 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 1 | — | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | — | — | — | — | 1 |
| Acinar cell carcinoma | D018267 | — | — | 1 | — | — | — | — | 1 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 1 | — | — | — | — | 1 |
| Carcinoid tumor | D002276 | — | D3A.00 | 1 | — | — | — | — | 1 |
| Astrocytoma | D001254 | EFO_0000271 | — | 1 | — | — | — | — | 1 |
| Oligodendroglioma | D009837 | EFO_0000631 | — | 1 | — | — | — | — | 1 |
Show 14 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Meningeal neoplasms | D008577 | EFO_0003851 | C70 | — | — | — | — | 1 | 1 |
| Meningeal carcinomatosis | D055756 | EFO_1001012 | — | — | — | — | — | 1 | 1 |
| Meningitis | D008581 | EFO_0000584 | G03 | — | — | — | — | 1 | 1 |
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | — | — | — | — | 1 | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sorafenib |
| INN | sorafenib |
| Description | Sorafenib is a member of the class of phenylureas that is urea in which one of the nitrogens is substituted by a 4-chloro-3-trifluorophenyl group while the other is substituted by a phenyl group which, in turn, is substituted at the para position by a [2-(methylcarbamoyl)pyridin-4-yl]oxy group. It has a role as an antineoplastic agent, an EC 2.7.11.1 (non-specific serine/threonine protein kinase) inhibitor, a tyrosine kinase inhibitor, an angiogenesis inhibitor, an anticoronaviral agent and a ferroptosis inducer. It is a pyridinecarboxamide, a member of monochlorobenzenes, an aromatic ether, a member of (trifluoromethyl)benzenes and a member of phenylureas. |
| Classification | Small molecule |
| Drug class | rapidly accelerated fibrosarcoma (RAF) kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)cc2)ccn1 |
Identifiers
| PDB | — |
| CAS-ID | 284461-73-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1336 |
| ChEBI ID | 50924 |
| PubChem CID | 216239 |
| DrugBank | DB00398 |
| UNII ID | 9ZOQ3TZI87 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CDK19
CDK19
BRAF
BRAF
FGFR1
FGFR1
Organism
Homo sapiens
Gene name
CDK19
Gene synonyms
CDC2L6, CDK11, KIAA1028
NCBI Gene ID
Protein name
cyclin-dependent kinase 19
Protein synonyms
CDC2-related protein kinase 6, CDK8-like cyclin-dependent kinase, cell division cycle 2-like 6 (CDK8-like), Cell division cycle 2-like protein kinase 6, Cell division protein kinase 19, cyclin-dependent kinase (CDC2-like) 11, Cyclin-dependent kinase 11, Death-preventing kinase
Uniprot ID
Mouse ortholog
Cdk19 (78334)
cyclin-dependent kinase 19 (Q8BWD8)
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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30,816 adverse events reported
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