Alogliptin

Medical uses

Alogliptin is a dipeptidyl peptidase-4 inhibitor (DDP-4) that decreases blood sugar levels similar to other DPP-4 inhibitors.

Side effects

Adverse events include hypoglycemia, Like other DDP-4 inhibitors, alogliptin is weight-neutral.

A 2014 letter to the editor claimed alogliptin is not associated with increased risk of cardiovascular events. In April 2016, the U.S. Food and Drug Administration (FDA) added a warning about increased risk of heart failure.

Market access

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 The company also filed a Marketing Authorization Application elsewhere outside the United States, which was withdrawn in June 2009 needing more data.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.

References

References

1. "Vipidia". European Medicines Agency.
2. "www.aace.com".
3. "FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin".
4. "The San Diego Union-Tribune - San Diego, California & National News".
5. "The Top 300 of 2020".
6. "Alogliptin - Drug Usage Statistics".
7. (2015). "Alogliptin benzoate for management of type 2 diabetes". Vascular Health and Risk Management.
8. (2015-08-28). "DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain".
9. (January 2014). "Saxagliptin, alogliptin, and cardiovascular outcomes". The New England Journal of Medicine.
10. (May 2025). "Highlights of Prescribing Information: Nesina". US Food and Drug Administration.
11. (May 2025). "Highlights of Prescribing Information: Kazano". US Food and Drug Administration.
12. "Highlights of Prescribing Information: Oseni". US Food and Drug Administration.
13. (June 4, 2009). "GEN News Highlights: Takeda Pulls MAA for Type 2 Diabetes Therapy". [[Genetic Engineering & Biotechnology News]].
14. (April 26, 2012). "FDA wants yet more data on Takeda diabetes drug alogliptin". PharmaTimes.
15. (May 2007). "Discovery of alogliptin: a potent, selective, bioavailable, and efficacious inhibitor of dipeptidyl peptidase IV". Journal of Medicinal Chemistry.
16. (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.
17. (June 2012). "Alogliptin as an initial therapy in patients with newly diagnosed, drug naïve type 2 diabetes: a randomized, control trial". Endocrine.
18. (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.
19. (January 3, 2008). "Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.". [[Takeda Pharmaceutical Company]].