Routes ofadministration Oral Bioavailability 100% | ATC code A10BH04 (WHO) Protein binding 20% | |
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Pregnancycategory US: B (No risk in non-human studies) Legal status In general: ℞ (Prescription only) Metabolism | ||
Alogliptin and metformin to improve blood sugar control for type 2 diabetes overview
Alogliptin (trade name Nesina in the US and Vipidia in Europe) is an orally administered anti-diabetic drug in the DPP-4 inhibitor class, developed by Syrrx, a company which was acquired by Takeda Pharmaceutical Company in 2005. Like other medications for the treatment of Type 2 diabetes, 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 causing hypoglycemia, and exhibits relatively modest glucose-lowering activity. Alogliptin and other gliptins are commonly used in combination with metformin in patients whose diabetes cannot adequately be controlled with metformin alone. In April 2016, the U.S. FDA added a warning about increased risk of heart failure.
Contents
- Alogliptin and metformin to improve blood sugar control for type 2 diabetes overview
- Unintened effects of fda diabetes guidelines alogliptin case mov
- Medical uses
- Side effects
- Market access
- References
Unintened effects of fda diabetes guidelines alogliptin case mov
Medical uses
Alogliptin is a dipeptidyl peptidase-4 inhibitor that decreases blood sugar similar to the other.
Side effects
Adverse events include mild hypoglycemia based on clinical studies. It may cause severe joint pain.
Alogliptin is not associated with increased weight, increased risk of cardiovasular events. In April 2016, the U.S. 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 (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 The company also filed a Marketing Authorization Application (MAA) elsewhere outside the United States, which was withdrawn in June 2009 needing more data.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.
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.