An FDA Advisory Committee recommended the approval of Canagliflozin, CAS# 842133-18-0, for the treatment of type 2 diabetes. The approval in January 2013 was an encouraging move for Johnson and Johnson, who will market Canagliflozin as the brand Invokana. As an inhibitor of subtype 2 sodium-glucose transport protein (SGLT2), which is responsible for at least 90% of the glucose reabsorption in the kidney, Canagliflozin has proven to be efficacious in studies.
On June 9, 2012 Janssen Research & Development announced the results from five Phase lll clinical trials, which were presented at the 72nd American Diabetes Association Annual Scientific Sessions. Two of these studies compared Canagliflozin to the current standard treatments of sitagliptin and glimepiride. Results in favor of Canagliflozin were positive, showing that a 300 mg dose of Canagliflozin once daily provided significantly greater reductions in A1C levels relative to both comparators. In addition, when compared to the standard treatments of sitagliptin and glimepiride the incidence of adverse effects was similar.
“This is the largest late-stage clinical trial and development program for an investigational product to treat type 2 diabetes submitted to health authorities worldwide, as of late 2012.”
The global Phase 3 Canagliflozin trial enrolled over 10,300 patients in nine studies. This is the largest late-stage clinical trial and development program for an investigational product to treat type 2 diabetes submitted to health authorities worldwide, as of late 2012. Both the efficacy and safety profile of Canagliflozin was diligently studied across a wide spectrum of type 2 diabetes management. The vast array of treatment management included adult patients with type 2 diabetes who were treated only with diet and exercise, to adult patients with type 2 diabetes who needed regular insulin injections to maintain their glycemic control. There were also three large studies which encompassed patients in special populations, which were older adult patients with type 2 diabetes, adult patients with type 2 diabetes who currently had moderate renal impairment, and patients with type 2 diabetes who had or were considered to be at high risk for cardiovascular disease. These widespread and inclusive studies have created a genuine excitement and hope for Canagliflozin among not only the pharmaceutical industry, but also for those physicians and patients dealing with type 2 diabetes on a daily basis.
LGM Pharma provides the API Canagliflozin for research and development purposes. Clients can be assured of quality products and continuous support throughout the R&D process.
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.