NDAORALTABLETPriority Review
Approved
Dec 2005
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
NEXAVAR (sorafenib) by Bayer is protein kinase inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2005.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEXAVAR (sorafenib) is an oral small-molecule protein kinase inhibitor approved in 2005 for treating various cancers including hepatocellular carcinoma, renal cell carcinoma, and differentiated thyroid cancer. It works by blocking multiple kinases involved in tumor growth and angiogenesis. The drug represents a foundational kinase inhibitor in Bayer's oncology portfolio.
$8MPart D
LOE ApproachingDeclining
2.0 years to LOEProduct approaching loss of exclusivity with modest Part D spending signals a mature, declining commercial phase requiring transition planning and focus on managed markets rather than growth.
Mechanism of Action
Protein Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Real World Study of Effectiveness of Sunitinib or Sorafenib to Chinese Unresectable Locally Advanced or Metastatic PRCC
Started Mar 2025
150 enrolled
Papillary Renal Cell Carcinoma
An Observational Study, Called ROCURS, to Learn About COVID-19 Related Outcomes in People With Cancer Who Are Treated With Tyrosine Kinase Inhibitors (TKIs) Including Regorafenib or Sorafenib
Started Oct 2022
4,103 enrolled
Malignant Solid TumorsCoronavirus Disease 2019 (COVID-19)SARS-CoV-2 Infection
Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer
Started Oct 2021
10 enrolled
Pancreas Cancer
A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
Started Apr 2021
557 enrolled
Unresectable Hepatocellular Carcinoma
A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC
Started Feb 2021
344 enrolled
Hepatocellular Carcinoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.