NDAORALTABLETPriority Review
Approved
Sep 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
59
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 13h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
STIVARGA (regorafenib) is an oral small-molecule kinase inhibitor developed by Bayer and approved in 2012. It is indicated for metastatic colorectal cancer, gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma. The drug works by inhibiting multiple tyrosine kinases involved in tumor angiogenesis and oncogenesis.
$0.111BPart D
Peak5.8 years to LOEAt peak lifecycle with $111M in Part D spending (2023), STIVARGA supports a mature commercial organization focused on maximizing market penetration in its established oncology segments.
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 (59)
A Study of Velzatinib in Participants With Metastatic and/or Unresectable GIST After Imatinib, Sunitinib, Regorafenib, and Pimitespib
Started Aug 2026
24 enrolled
Gastrointestinal Neoplasms
Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma
Started Aug 2026
0Unresectable Hepatocellular CarcinomaHepatocellular Carcinoma
A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer
Started Mar 2026
60 enrolled
Colorectal Cancer Metastatic
Regorafenib (Reg) and Lorigerlimab (Lor), RELO Regimen, in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy [ReLOAD Trial]
Started Feb 2026
16 enrolled
Colorectal CancerRegorafenibHigh Risk Patients
A Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cancer
Started Oct 2025
0Rectal CancerRectal Cancer Recurrent
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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.