|Trade names||Nesina, Vipidia|
Kazano, Vipidomet (with metformin)
Oseni, Incresync (with pioglitazone)
|Metabolism||Limited, hepatic (CYP2D6- and 3A4-mediated)|
|Elimination half-life||12–21 hours|
|Excretion||Renal (major) and fecal (minor)|
|CompTox Dashboard (EPA)|
|Chemical and physical data|
|Molar mass||339.39 g/mol g·mol−1|
|3D model (JSmol)|
|(what is this?)|
Alogliptin (trade name Nesina and Vipidia) is an oral anti-diabetic drug in the DPP-4 inhibitor (gliptin) class. Alogliptin does not decrease the risk of heart attack and stroke. 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. Alogliptin and other gliptins are commonly used in combination with metformin in people whose diabetes cannot adequately be controlled with metformin alone.
Adverse events include mild hypoglycemia based on clinical studies. Alogliptin is not associated with increased weight, increased risk of cardiovascular events. It may also cause joint pain that can be severe and disabling. In April 2016, the U.S. FDA added a warning about increased risk of heart failure.
In December 2007, Takeda submitted a New Drug Application (NDA) for alogliptin to the United States Food and Drug Administration (USFDA), after positive results from Phase III clinical trials. In September 2008, the company also filed for approval in Japan, winning approval in April 2010. The company also filed a Marketing Authorization Application (MAA) elsewhere outside the United States, which was withdrawn in June 2009 needing more data. The first USFDA NDA failed to gain approval and was followed by a pair of NDAs (one for alogliptin and a second for a combination of alogliptin and pioglitazone) in July 2011. In 2012, Takeda received a negative response from the USFDA on both of these NDAs, citing a need for additional data.
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- Bosi, Emanuele; Ellis, G.C.; Wilson, C.A.; Fleck, P.R. (October 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 and Metabolism (published October 27, 2011), 13 (12): 1088–1096, doi:10.1111/j.1463-1326.2011.01463.x, PMID 21733058
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- "DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain". FDA. 2015-08-28. Retrieved 1 September 2015.
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