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.
For type 2 diabetes mellitus. Sold as Zituvio. Every FDA application for this active ingredient: 1 branded and 4 generic.
As of Nov 14, 2026, FDA lists 5 applications for Sitagliptin (sold as Zituvio), first approved Oct 18, 2023, with 0 new uses approved and 1 published complete response letter.
First approved: Oct 18, 2023
Applications: 5
New uses approved: 0
Complete response letters: 1
Medicare spending, 2025: $2.17B
First approved in the EU: Mar 20, 2007
First approved in Japan: Oct 16, 2009
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 168 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
JanuviaDrugs with a new indication for the treatment of type 2 diabetes mellitus. · Ono Pharmaceutical Co., Ltd. · May 23, 2014
GlactivDrugs with a new additional indication for the treatment of type 2 diabetes mellitus in patients who have not responded sufficiently to insulin along with… · MSD K.K. · Sep 16, 2011
JanuviaDrugs with a new additional indication for the treatment of type 2 diabetes mellitus in patients who have not responded sufficiently to alpha- glucosidase… · Ono Pharmaceutical Co., Ltd. · May 20, 2011
Januvia, new ingredientDrugs with a new active ingredient indicated for the treatment of type 2 diabetes mellitus (for use only in patients who do not sufficiently respond to any… · Ono Pharmaceutical Co., Ltd. · Oct 16, 2009 · Review report
Clinical Trials
28 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
Zydus Lifesciences