Alogliptin, sold under the brand namesNesina andVipidia,[2][3] is an oralanti-diabetic drug in theDPP-4 inhibitor (gliptin) class.[4] Like other members of the gliptin class, it causes little or no weight gain, exhibits relatively little risk of hypoglycemia, and has relatively modest glucose-lowering activity.[1] Alogliptin and other gliptins are commonly used in combination with metformin in people whose diabetes cannot adequately be controlled with metformin alone.[1]
In April 2016, the U.S.Food and Drug Administration (FDA) added a warning about increased risk ofheart failure.[5] It was developed by Syrrx, a company which was acquired byTakeda Pharmaceutical Company in 2005.[6] In 2020, it was the 295th most commonly prescribed medication in the United States, with more than 1million prescriptions.[7][8]
A 2014 letter to the editor claimed alogliptin is not associated with increased risk of cardiovascular events.[15][better source needed] In April 2016, the U.S. Food and Drug Administration (FDA) added a warning about increased risk ofheart failure.[5]
Alogliptin tablets sales in mainland China. Specification is 25 mg × 10 tablets.
In December 2007, Takeda submitted aNew Drug Application (NDA) for alogliptin to theUnited States Food and Drug Administration (FDA),[16] after positive results fromPhase III clinical trials.[2] In September 2008, the company also filed for approval in Japan,[17] winning approval in April 2010.[16] The company also filed aMarketing Authorization Application elsewhere outside the United States, which was withdrawn in June 2009 needing more data.[17] The first NDA failed to gain approval and was followed by a pair of NDAs (one for alogliptin and a second for a combination of alogliptin andpioglitazone) in July 2011.[16] In 2012, Takeda received a negative response from the FDA on both of these NDAs, citing a need for additional data.[16]
In 2013, the FDA approved the drug in three formulations: as a stand-alone with the brand-name Nesina,[13] combined withmetformin using the name Kazano,[18] and when combined withpioglitazone as Oseni.[19]
^Seino Y, Fujita T, Hiroi S, Hirayama M, Kaku K (September 2011). "Efficacy and safety of alogliptin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, dose-ranging comparison with placebo, followed by a long-term extension study".Current Medical Research and Opinion.27 (9):1781–1792.doi:10.1185/03007995.2011.599371.PMID21806314.S2CID24082863.
^Kutoh E, Ukai Y (June 2012). "Alogliptin as an initial therapy in patients with newly diagnosed, drug naïve type 2 diabetes: a randomized, control trial".Endocrine.41 (3) (published January 17, 2012):435–441.doi:10.1007/s12020-012-9596-0.PMID22249941.S2CID45948727.
^Bosi E, Ellis GC, Wilson CA, Fleck PR (December 2011). "Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52-week, randomized, double-blind, active-controlled, parallel-group study".Diabetes, Obesity & Metabolism.13 (12) (published October 27, 2011):1088–1096.doi:10.1111/j.1463-1326.2011.01463.x.PMID21733058.S2CID1092260.
^White WB, Zannad F (January 2014). "Saxagliptin, alogliptin, and cardiovascular outcomes".The New England Journal of Medicine.370 (5): 484.doi:10.1056/NEJMc1313880.PMID24482824.
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