LIPAGLYN - The world’s first drug for treating diabetic dyslipidemiacombines lipid and glucose lowering effects in one single molecule.
Lipaglyn™, is a novel drug targeted at bridging an unmet healthcare need for treating
Diabetic Dyslipidemia or Hypertriglyceridemia in type 2 diabetes, not controlled by
statins alone. Lipaglyn™, a once-daily, oral drug, recommended in strength of 4 mg, has been rationally designed to have high specificity of PPAR-alpha and moderate activity on PPAR-gamma receptors to optimize beneficial effects on lipids and
glycemic control without any safety concerns.
Discovered by Zydus Research Centre, the dedicated NCE research arm of the Zydus group, Lipaglyn™ is a best-in-class innovation, designed to have a unique cellular mechanism of action following an extensive structure-activity relationship study initiated in the year 2000. Lipaglyn™ has a predominant affinity to PPAR alpha isoform and moderate affinity to PPAR gamma isoform of PPAR nuclear receptor sub-family. The molecule has shown beneficial effects on lipids and glycemic control without side effects. This molecule underwent extensive pre-clinical characterization and the IND was submitted in the year 2004.
As a part of the clinical development programme, extensive Phase-I, Phase-II and Phase-III clinical trials were conducted to evaluate the phamacokinetics, pharmacodynamics, efficacy and safety of Lipaglyn™. The new drug application for Lipaglyn™ was based on a comprehensive clinical development programme spanning eight years.
Results from the first Phase III programme with Pioglitazone as a comparator drug in diabetic patients showed that the 4 mg dose of Lipaglyn™ led to a reduction of triglycerides and LDL (bad) cholesterol, and an increase in HDL (good) cholesterol and also showed a reduction in Fasting Plasma Glucose and glycosylated haemoglobin (HbA1c) thereby confirming its beneficial effects of both lipid and glycemic control in diabetic patients.
In the second Phase III study, Lipaglyn™ was studied in diabetic dyslipidemic patients insufficiently controlled with statin therapy. The results from this study confirmed that Lipaglyn™ had a pronounced beneficial effect on both the lipid and glycemic parameters in these subjects.
In both the studies, Lipaglyn™ was well tolerated and had a better safety profile than the comparators. Importantly, Lipaglyn™ has a non-renal route of elimination, and did not show adverse events like edema, weight gain, myopathies or derangement of liver and/or kidney functions, thus making it safe and efficacious. Lipaglyn™ is recommended for once daily administration as 4 mg tablets.
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