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Dance-501 is a preservative-free, recombinant human insulin formulated as a high-purity liquid for pulmonary delivery via a proprietary soft-mist, electronic vibrating-mesh inhaler developed by Dance Biopharm (now Aerami Therapeutics) for prandial treatment of diabetes, primarily type 2 diabetes.[2][3][4][8][11][14] The drug–device combination generates a gentle, aqueous aerosol of insulin that is rapidly absorbed through the lungs, producing glucodynamic effects comparable to subcutaneous insulin lispro but with a faster onset of action and greater early glucose-lowering effect in clamp studies.[3][4][8][9] Phase 2 crossover trials have shown linear dose–response, predictable pharmacokinetics and pharmacodynamics, and good pulmonary tolerability, with no cough or acute changes in lung function reported, supporting its potential as an alternative to rapid‑acting injectable insulin for mealtime glucose control.[2][3][4][8][9]
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