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HDV-insulin (hepatic-directed vesicle insulin) is an investigational formulation designed to deliver insulin directly to the liver using a proprietary hepatocyte-targeting molecule embedded in a phospholipid vesicle. The technology mimics physiological portal vein delivery of insulin by targeting hepatocytes after subcutaneous or oral administration. The vesicles are less than 150 nm in diameter and contain biotin-phosphatidylethanolamine as the targeting moiety. This targeted approach aims to enhance hepatic glucose uptake and glycogen storage while reducing peripheral exposure and risk of hypoglycemia compared to conventional insulins. Preclinical studies have shown that HDV-insulin can stimulate hepatic glucose uptake at much lower doses than regular insulin, with favorable safety profiles in animal models[1][2][6]. Clinical trials have demonstrated noninferiority for glycemic control versus standard rapid-acting insulins in type 1 diabetes, with potential benefits for reducing hypoglycemia—especially nocturnal events—when added to basal-bolus regimens[5][7]. The drug is being developed primarily for type 1 diabetes but may also be relevant for type 2 diabetes management[4].
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