Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats advanced renal cell carcinoma (RCC). Sold as Inlyta. Every FDA application for this active ingredient: 1 branded and 3 generic.
As of Nov 14, 2026, FDA lists 4 applications for Axitinib (sold as Inlyta), first approved Jan 27, 2012, with 2 new uses approved and 0 published complete response letters.
First approved: Jan 27, 2012
Applications: 4
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $488M
First approved in the EU: Sep 3, 2012
First approved in Japan: Jun 29, 2012
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 5 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Inlyta, new ingredientDrugs with a new active ingredient indicated for the treatment of unresectable or metastatic renal cell carcinoma. · Pfizer Japan Inc. · Jun 29, 2012
Clinical Trials
56 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