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AMP-005

Development stage: Preclinical
Lead developer: Amphastar Pharmaceuticals
Modality: Recombinant Proteins and Enzymes
Administration: Subcutaneous, Intravenous

Overview

AMP-005 is a recombinant human insulin biosimilar developed by Amphastar Pharmaceuticals and its subsidiary, Amphastar France Pharmaceuticals. It functions as an agonist of the insulin receptor, mimicking the action of endogenous insulin to facilitate glucose uptake into cells and suppress hepatic glucose output. This injectable recombinant protein is intended for the management of diabetes mellitus. The manufacturing process utilizes recombinant DNA technology at the company's facility in France. As of early 2026, AMP-005 is in the IND-enabling stage of development and is being designed as an interchangeable insulin product.

Other names: Recombinant Human Insulin

Targets

INSR (Insulin receptor)

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