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Insulin (recombinant human, concentrated, BIOD-531 formulation)

Development stage: Phase 2
Lead developer: Biodel
Modality: Recombinant Proteins and Enzymes, Small Molecules
Administration: Subcutaneous

Overview

BIOD-531 is a proprietary ultra-rapid-acting concentrated formulation of recombinant human insulin (RHI) developed by Biodel. It is formulated at 400 units/mL (U-400) and includes EDTA, citrate, and magnesium sulfate as excipients. The drug exhibits a biphasic absorption profile characterized by rapid onset to address prandial glucose spikes and an extended duration suitable for basal insulin needs. This unique pharmacokinetic and pharmacodynamic profile allows BIOD-531 to provide both meal-time (prandial) and background (basal) glucose control with a single injection. It was specifically designed for patients with type 2 diabetes who are severely insulin resistant or require premixed insulins but do not achieve adequate glycemic control with existing formulations[1][4][5][8]. Clinical studies have demonstrated that BIOD-531 offers superior postprandial glucose control compared to Humalog Mix 75/25 and Humulin R U-500 in this patient population[1][8].

Other names: Humalog Mix 75/25-Biodel-type 2 diabetes mellitus

Targets

INSR (Insulin receptor)

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