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Drug ReportsSorafenib
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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Events Timeline
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
digestive system diseasesD004066
urogenital diseasesD000091642
endocrine system diseasesD004700
Trade Name
FDA
EMA
Nexavar, Sorafenib
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sorafenib tosylate
Tradename
Company
Number
Date
Products
NEXAVARBayerN-021923 RX2005-12-20
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
nexavarNew Drug Application2023-08-28
sorafenibANDA2024-12-11
sorafenib tosylateANDA2024-07-26
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Sorafenib Tosylate, Nexavar, Bayer Hlthcare
97374882028-09-10DPU-1480, U-1696, U-2107
88779332027-12-24DS, DPU-1624
86181412023-02-11U-1480
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
L01EX: Other protein kinase inhibitors in atc
L01EX02: Sorafenib
HCPCS
No data
Clinical
Clinical Trials
864 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277C80.07291222170
Renal cell carcinomaD002292EFO_0000376715611239
Hepatocellular carcinomaD006528C22.0217611238
Liver neoplasmsD008113EFO_1001513C22.0216611237
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C801782125
Lung neoplasmsD008175C34.9069317
Non-small-cell lung carcinomaD00228977416
Breast neoplasmsD001943EFO_0003869C50491113
MelanomaD0085452417
Thyroid neoplasmsD013964EFO_00038412125
Thyroid diseasesD013959E00-E072125
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C957911
Myeloid leukemiaD007951C92579
Myeloid leukemia acuteD015470C92.0568
Myelodysplastic syndromesD009190D46567
PreleukemiaD011289456
Colorectal neoplasmsD015179335
SyndromeD013577345
Neoplasm metastasisD009362EFO_0009708235
GlioblastomaD005909EFO_0000515235
Pancreatic neoplasmsD010190EFO_0003860C25234
Show 43 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain neoplasmsD001932EFO_0003833C7122
Gastrointestinal neoplasmsD005770C26.911
Digestive system neoplasmsD00406711
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A11
Pancreatic ductal carcinomaD02144111
Acinar cell carcinomaD01826711
Neuroendocrine tumorsD018358EFO_1001901D3A.811
Carcinoid tumorD002276D3A.0011
AstrocytomaD001254EFO_000027111
OligodendrogliomaD009837EFO_000063111
Show 14 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Meningeal neoplasmsD008577EFO_0003851C7011
Meningeal carcinomatosisD055756EFO_100101211
MeningitisD008581EFO_0000584G0311
Barrett esophagusD001471EFO_0000280K22.711
Covid-19D000086382U07.111
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSorafenib
INNsorafenib
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 classrapidly accelerated fibrosarcoma (RAF) kinase inhibitors
Image (chem structure or protein)Loading
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-ID284461-73-0
RxCUI
ChEMBL IDCHEMBL1336
ChEBI ID50924
PubChem CID216239
DrugBankDB00398
UNII ID9ZOQ3TZI87 (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
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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30,605 adverse events reported
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