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Sold as Stivarga. Every FDA application for this active ingredient: 2 branded and 1 generic.
As of Nov 14, 2026, FDA lists 3 applications for Regorafenib (sold as Stivarga), first approved Sep 27, 2012, with 2 new uses approved and 0 published complete response letters.
First approved: Sep 27, 2012
Applications: 3
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $109M
First approved in the EU: Aug 26, 2013
First approved in Japan: Mar 25, 2013
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 6 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
StivargaA drug with a new additional indication for the treatment of unresectable hepatocellular carcinoma which has progressed after cancer chemotherapy. · Bayer Yakuhin, Ltd. · Jun 26, 2017 · Review report
StivargaA drug with a new additional indication for the treatment of gastrointestinal stromal tumor which has progressed after cancer chemotherapy. · Bayer Yakuhin, Ltd. · Aug 20, 2013
Stivarga tablets, new ingredientA drug with a new active ingredient indicated for the treatment of unresectable advanced or recurrent colorectal cancer. · Bayer Yakuhin, Ltd. · Mar 25, 2013 · Review report
Clinical Trials
96 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Bayer Hlthcare