STIVARGA
PeakNDAORALTABLETPriority Review
Approved
Feb 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 11h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
STIVARGA (regorafenib) is an oral small-molecule multi-kinase inhibitor that targets membrane-bound and intracellular kinases involved in tumor growth, angiogenesis, and metastasis. It is indicated for metastatic colorectal cancer (after prior chemotherapy and anti-VEGF therapy), unresectable or metastatic gastrointestinal stromal tumor (GIST) after sunitinib failure, and hepatocellular carcinoma. The drug works by inhibiting VEGFR, KIT, PDGFR, FGFR, RAF, and other kinases to suppress tumor angiogenesis and growth.
Peak
Product at peak maturity with moderate competitive pressure (30/100) suggests stable but not expanding commercial infrastructure.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
An Observational Study, Called RegoFlex EU, to Learn More About the Use of Stivarga at Reduced Doses as Recommended (Flexible Dosing) to Treat People With Metastatic Colorectal Cancer in Real World Settings in Europe
Started Aug 2022
300 enrolled
Metastatic Colorectal Cancer
Stivarga Real Life Evidence in Hungary
Started Jul 2016
400 enrolled
Colorectal Neoplasms
Stivarga Regulatory Post-Marketing Surveillance Study in Korea
Started Jun 2014
316 enrolled
Colorectal Neoplasms
Refametinib (BAY86-9766) in Combination With Regorafenib (Stivarga, BAY73-4506) in Patients With Advanced or Metastatic Cancer
Started Jun 2014
20 enrolled
Neoplasms
Investigating the Use of Regorafenib (Stivarga®) in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy
Started Oct 2013
483 enrolled
Colorectal Neoplasm
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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.