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 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
STIVARGA (regorafenib) is an oral small-molecule tyrosine kinase inhibitor approved in 2012 for treatment of metastatic colorectal cancer, gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma. It works by inhibiting multiple kinases involved in tumor angiogenesis and oncogenesis. The drug is administered as a once-daily oral tablet on a 3-weeks-on, 1-week-off dosing schedule.
$111MPart D
Peak6.1 years to LOEProduct is at peak lifecycle stage with sustained Medicare spending, indicating established market presence and stable commercial team headcount.
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)
Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma
Started Aug 2026
30 enrolled
Unresectable 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
A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer
Started May 2025
23 enrolled
Pancreatic Cancer Metastatic
Worked on STIVARGA at Bayer? Share your interview experience or compensation data (+7 days Pro)
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.