Alogliptin Shines in Three Recent FDA Approvals


Alogliptin is a current newsmaker in the pharmaceutical industry. On January 25, 2013 Takeda announced that Alogliptin, CAS# 850649-62-6, was approved alongside Metformin HCl, CAS# 1115-70-4, in the novel type 2 diabetes medication Kazano. As an efficacious and highly selective DPP-4 inhibitor, Alogliptin, when combined in this single dose tablet with metformin HCI effectively aids patients, alongside dietary and lifestyle changes. The easy once a day dosing schedule, in one tablet, makes Kazano a preferable choice for many patients. Adverse effects of Kazano may include upper respiratory tract infections, mild diarrhea, headache and mild back pain.  For many patients with type 2 diabetes the side effects are outweighed greatly by the benefits of this dynamic combination of alogliptin and metformin. Metformin has been a gold standard member of the biguanide class of medications, and it is typically a first-line therapy in addition to diet and exercise for patients with type 2 diabetes. The addition of alogliptin with metformin makes for a formidable combination, by helping to regulate blood glucose levels and improve pancreatic beta-cell function.

“The FDA approved these three formulations of alogliptin, to be taken alongside a dietary and exercise program to control type 2 diabetes.”

The FDA approval of Kazano was based on positive findings from the clinical trials of alogliptin and metformin, which involved over 4,000 patients.  Results from studies showed that when alogliptin was administered with either metformin or Pioglitazone, CAS# 112529-15-4, patients experienced significant improvements in their glycemic control, as compared to monotherapies.  In the same class of drugs as Januvia, which generated sales of roughly $3.3 billion in 2011, alogliptin is slated to succeed. In fact, three formulation of alogliptin were approved in late January 2013 by the FDA:  Nesina, which are fixed dose alogliptin tablets; Oseni, which combine both alogliptin and pioglitazone; and the aforementioned Kazano, which is the alogliptin and metformin hydrochloride tablet. The FDA approved these three formulations of alogliptin, to be taken alongside a dietary and exercise program to control type 2 diabetes. These approvals are based on data from separate studies for all 3 formulations.  There were 14 clinical trials of alogliptin as a monotherapy, which involved 8,500 patients with type 2 diabetes. Results from these 14 trials were noteworthy, producing hemoglobin A1C reductions of 0.4 to 0.6 percentage points at 26 weeks when compared with a placebo. The alogliptin and pioglitazone combination was involved in 4 clinical trials, which included a little over 1,500 patients. Results from these studies indicated additional A1C reductions of 0.4 to 0.6 percentage points over pioglitazone monotherapy, and 0.4 to 0.9 percentage points over alogliptin alone.  Dosages of these 3 formulations of alogliptin, all developed and marketed by Takeda are: Nesina (alogliptin) 6.25 mg, 12.5 mg, and 25 mg Tablets; Kazano (alogliptin and metformin HCl) 12.5 mg/500 mg and 12.5 mg/1000 mg Tablets; and Oseni (alogliptin and pioglitazone) 25 mg/15 mg, 25 mg/30 mg, 25 mg/45 mg, 12.5 mg/15 mg, 12.5 mg/30 mg, and 12.5 mg/45 mg tablets.

LGM Pharma provides alogliptin for research and development purposes, and offers clients continued support throughout the R&D process. Type 2 diabetes is the most common form of diabetes affecting patients globally, and the United States alone has over 23 million people suffering from this condition. Continued research and development of new and innovative treatments to combat this ever growing patient population is not only prudent, but also extremely necessary.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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