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Nexavar (SORAFENIB)
Nexavar (Sorafenib) is a small molecule kinase inhibitor developed by Bayer Healthcare, targeting vascular endothelial growth factor receptor 2. It is a multi-kinase inhibitor used to treat various cancers, including thyroid, liver, and renal cell carcinoma. Nexavar was FDA-approved in 2005 and remains a commercial product, with multiple generic manufacturers available. Key safety considerations include its potential to cause liver damage, skin reactions, and hypertension. As a patented product, Nexavar's commercial status is subject to ongoing patent protection.
At a glance
| Generic name | SORAFENIB |
|---|---|
| Sponsor | Bayer |
| Drug class | Kinase Inhibitor [EPC] |
| Target | Vascular endothelial growth factor receptor 2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2005 |
| Annual revenue | 200 |
Approved indications
- Carcinoma of thyroid
- Liver cell carcinoma
- Renal cell carcinoma
Common side effects
- Diarrhea
- Fatigue
- Infection
- Alopecia
- Hand-foot skin reaction
- Rash
- Weight loss
- Decreased appetite
- Nausea
- Gastrointestinal and abdominal pains
- Hypertension
- Hemorrhage
Drug interactions
- High Risk QT Prolonging Agents
- amiodarone
- artemether
- bepridil
- carbamazepine
- cisapride
- dexamethasone
- disopyramide
- dronedarone
- droperidol
- fosphenytoin
- levomethadyl acetate
Key clinical trials
- A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma (PHASE3)
- Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer (PHASE3)
- Bortezomib, Sorafenib Tosylate, and Decitabine in Treating Patients With Acute Myeloid Leukemia (PHASE1)
- Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma (PHASE1)
- Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer (PHASE2)
- Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma (PHASE1)
- Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (PHASE3)
- MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nexavar CI brief — competitive landscape report
- Nexavar updates RSS · CI watch RSS
- Bayer portfolio CI