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Regorafenib · Stivarga

Small molecule · Inhibitor of RET, VEGFR1 (FLT1) and VEGFR2 (KDR) · developed by Bayer Hlthcare

Approved FDA, Sep 2012
1 Registered trials

What is Regorafenib?

Regorafenib is a small-molecule kinase inhibitor targeting multiple receptor tyrosine kinases including VEGFR, KIT, PDGFR, and RET. It inhibits angiogenesis and tumor growth in colorectal, gastrointestinal stromal, and hepatocellular carcinomas.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Stivarga, Regorafinib
Drug type
Small molecule
Targets
RET, VEGFR1 (FLT1), VEGFR2 (KDR), VEGFR3 (FLT4), KIT, PDGFR-alpha (PDGFRA)
Mechanism
Inhibitor of RET, VEGFR1 (FLT1) and VEGFR2 (KDR)
Pathways
angiogenesis, tumor growth inhibition
Therapy area
Oncology
Developer
Bayer Hlthcare
In trials of
BMY
FDA status
Approved as Stivarga (September 27, 2012), NDA203085 · FDA label
UNII
MGN125FS9D

✅ FDA-approved uses

From the indications section of the FDA label (version of Feb 9, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT03899155 Phase 2 Cancer Recruiting BMY

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Cancer

Other drugs acting on RET / FLT1 / KDR / FLT4 / KIT / PDGFRA

Midostaurin FDA approved Nintedanib FDA approved Pexidartinib FDA approved Selpercatinib FDA approved Sunitinib FDA approved 89Zr-DFOsq-olaratumab Phase 1 Barzolvolimab Phase 3 Bezuclastinib Phase 3 Briquilimab Phase 1/2 CDX 0158 Phase 1 Cediranib Phase 3 Olverembatinib Phase 3

Sources

Updated Oct 3, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.