Inhaled insulin first entered clinical human testing in the mid 1990s. Since then, the commercial potential and technical challenges of an inhaled insulin product have grown increasingly clear, with several pharmaceutical partnerships now targeting treatment of diabetes mellitus through inhalation products in clinical development. While clinical results to date show the therapy to be generally promising, recent data have raised questions related to human safety and slowed progress toward a commercial product. Answering these questions positively in the coming years will be critical to making inhalation therapy a practical diabetes-care reality.