Alogliptin, sold under the brand names Nesina and Vipidia,) is an oral

anti-diabetic drug Drugs used in diabetes treat diabetes mellitus by altering the glucose level in the blood. With the exceptions of insulin, most GLP receptor agonists ( liraglutide, exenatide, and others), and pramlintide, all are administered orally and are ...

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. In April 2016, the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) added a warning about increased risk of

heart failure Heart failure (HF), also known as congestive heart failure (CHF), is a syndrome, a group of signs and symptoms caused by an impairment of the heart's blood pumping function. Symptoms typically include shortness of breath, excessive fatigue, a ...

. It was developed by Syrrx, a company which was acquired by

Takeda Pharmaceutical Company The is a Japanese multinational pharmaceutical company, with partial American and British roots. It is the largest pharmaceutical company in Asia and one of the top 20 largest pharmaceutical companies in the world by revenue (top 10 followin ...

in 2005. In 2020, it was the 295th most commonly prescribed medication in the United States, with more than 1million prescriptions.

Medical uses

Alogliptin is a

dipeptidyl peptidase-4 inhibitor Inhibitors of dipeptidyl peptidase 4 (DPP-4 inhibitors or gliptins) are a class of oral hypoglycemics that block the enzyme dipeptidyl peptidase-4 (DPP-4). They can be used to treat diabetes mellitus type 2. The first agent of the class – sita ...

that decreases blood sugar similar to the other.

Side effects

Adverse events include mild

hypoglycemia Hypoglycemia, also called low blood sugar, is a fall in blood sugar to levels below normal, typically below 70 mg/dL (3.9 mmol/L). Whipple's triad is used to properly identify hypoglycemic episodes. It is defined as blood glucose belo ...

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. Food and Drug Administration (FDA) added a warning about increased risk of

Market access

In December 2007, Takeda submitted a New Drug Application (NDA) for alogliptin to the

United States Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...

(USFDA), after positive results from

Phase III clinical trials The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases ...

. In September 2008, the company also filed for approval in Japan, winning approval in April 2010. The company also filed a

Marketing Authorization Application Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market. MAA is pa ...

(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 Pioglitazone, sold under the brand name Actos among others, is an anti-diabetic medication used to treat type 2 diabetes. It may be used with metformin, a sulfonylurea, or insulin. Use is recommended together with exercise and diet. It is not re ...

) in July 2011. In 2012, Takeda received a negative response from the USFDA 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 Metformin, sold under the brand name Glucophage, among others, is the main first-line medication for the treatment of type 2 diabetes, particularly in people who are overweight. It is also used in the treatment of polycystic ovary syndrome. ...

using the name Kazano, and when combined with

as Oseni.

References

External links

* * {{Portal bar , Medicine Dipeptidyl peptidase-4 inhibitors Nitriles Piperidines Ureas Imides Pyrimidinediones Enantiopure drugs Takeda Pharmaceutical Company brands Sanofi