In December 2007, Takeda submitted a New Drug Application (NDA) for alogliptin to the United States Food and Drug Administration (FDA), 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  The company also filed a Marketing Authorization Application elsewhere outside the United States, which was withdrawn in June 2009 needing more data.  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 and pioglitazone) in July 2011.  In 2012, Takeda received a negative response from the FDA on both of these NDAs, citing a need for additional data.
In 2013, the FDA approved the drug in three formulations: as a stand-alone with the brand-name Nesina, combined with metformin using the name Kazano, and when combined with pioglitazone as Oseni.