BIOD-090

BIOD-090 is an experimental ultra-rapid-acting prandial insulin formulation consisting of recombinant human insulin at 25 U/mL in an acidic solution containing disodium EDTA and other excipients designed to accelerate hexamer dissociation and absorption after subcutaneous injection.[1][7] Developed by Biodel as an early member of its ultra-rapid insulin family, BIOD-090 showed consistently faster insulin absorption, earlier onset of metabolic action, and improved early postprandial glycemic control compared with regular human insulin and insulin lispro in phase 1 studies, but was associated with increased injection-site discomfort attributed to its low pH and higher injection volume.[1][7] BIOD-090 advanced into phase 3 open-label safety and efficacy trials in type 1 and type 2 diabetes, where it achieved non-inferior HbA1c versus regular human insulin but with a higher incidence of mild-to-moderate local injection-site reactions, and it was later superseded by neutral pH U-100 follow-on formulations such as BIOD-100 (Linjeta/Viaject).[1]