My watch list  


Systematic (IUPAC) name
CAS number 284461-73-0
ATC code L01XE05
PubChem 216239
DrugBank APRD01304
Chemical data
Formula C21H16ClF3N4O3 
Mol. mass 464.825 g/mol
SMILES search in eMolecules, PubChem
Synonyms Nexavar
Sorafenib tosylate
Pharmacokinetic data
Bioavailability 29-49%
Protein binding 99.5%
Metabolism Hepatic oxidation and glucuronidation (CYP3A4-mediated)
Half life 25–48 hours
Excretion Fecal (77%) and renal (19%)
Therapeutic considerations
Licence data


Pregnancy cat.


Legal status


Routes Oral

Sorafenib (rINN), marketed as Nexavar by Bayer, is a drug approved for the treatment of advanced renal cell carcinoma (primary kidney cancer). It has also received "Fast Track" designation by the FDA[1] for the treatment of advanced hepatocellular carcinoma (primary liver cancer), and has since performed well in Phase III trials[2].



It is a small molecular inhibitor of Raf kinase, PDGF (platelet-derived growth factor), VEGF receptor 2 & 3 kinases and c Kit the receptor for Stem cell factor. A growing number of drugs target most of these pathways. The originality of Sorafenib lays in its simultaneous targeting of the Raf/Mek/Erk pathway.[3]


Sorafenib was approved by the U.S. Food and Drug Administration (FDA) on December 20, 2005 and received a E.U. marketing authorisation on July 19, 2006[4].

The European Commission has granted marketing authorization to Nexavar® (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer, on October 30, 2007. [5].


A New England Journal of Medicine article published in January 2007 showed compared with placebo, treatment with sorafenib prolongs progression-free survival in patients with advanced clear-cell renal-cell carcinoma in whom previous therapy has failed; the median progression-free survival was 5.5 months in the sorafenib group and 2.8 months in the placebo group (hazard ratio for disease progression in the sorafenib group, 0.44; 95% confidence interval [CI], 0.35 to 0.55; P<0.01). The first interim analysis of overall survival in May 2005 showed that sorafenib reduced the risk of death, as compared with placebo (hazard ratio, 0.72; 95% CI, 0.54 to 0.94; P=0.02), although this benefit was not statistically significant according to the O'Brien–Fleming threshold. Partial responses were reported as the best response in 10% of patients receiving sorafenib and in 2% of those receiving placebo (P<0.001).

At ASCO 2007, results from the SHARP trial were presented, which showed efficacy of sorafenib in hepatocellular carcinoma. The primary endpoint was overall survival, which showed a 44% improvement in patients who received sorafenib compared to placebo (hazard ratio 0.69; 95% CI, 0.55 to 0.87; p=0.0001). Both median survival and time to progression showed 3-month improvements.

Regulatory filing is planned.

Side effects

Side effects of sorafenib included skin rash, hand-foot skin reactions, diarrhea, and hypertension.

  • [http:/] Two year experience blog on nexavar, sutent, side effects, etc.
This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Sorafenib". A list of authors is available in Wikipedia.
Your browser is not current. Microsoft Internet Explorer 6.0 does not support some functions on Chemie.DE