STIVARGA
PeakNDAORALTABLETPriority Review
Approved
Feb 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
Priority Review
STIVARGA by Bayer is membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, metastasis and tumor immunity. Approved for oxaliplatin-, irinotecan-based chemotherapy, an anti-vegf therapy and 5 more indications. First approved in 2013.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
STIVARGA (regorafenib) is an oral small-molecule tyrosine kinase inhibitor approved by the FDA in February 2013 for treatment of advanced colorectal cancer and other solid tumors. The drug works by inhibiting multiple kinases involved in tumor angiogenesis and oncogenesis. It represents Bayer's targeted oncology portfolio in the kinase inhibitor space.
Peak
Product is in peak commercial lifecycle with established market presence; competitive pressure at 30% suggests room for growth but requires sustained commercial execution.
Mechanism of Action
membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, metastasis and tumor immunity. In in vitro biochemical or cellular assays, regorafenib or its major human active metabolites M-2 and M-5 inhibited the…
Indications (8)
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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.