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I004

Development stage: Phase 3
Lead developer: Amphastar Pharmaceuticals
Modality: Recombinant Proteins and Enzymes
Administration: Subcutaneous

Overview

I004 (also known as AMP-004) is a rapid-acting insulin aspart biosimilar candidate developed by Amphastar Pharmaceuticals. It is being developed as a biosimilar to Novo Nordisk's NovoLog (insulin aspart). Insulin aspart is a recombinant human insulin analog where the amino acid proline at position B28 is replaced by aspartic acid, a modification that reduces the tendency of the molecule to form hexamers, thereby increasing the rate of absorption and allowing for a faster onset of action compared to regular human insulin. I004 is intended to improve glycemic control in adults and pediatric patients with diabetes mellitus. The drug has been filed with the FDA, with a commercial launch anticipated in 2027.

Other names: insulin aspart biosimilar

Targets

INSR (Insulin receptor)

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