TSR-066

**TSR-066** is a novel drug-device combination product developed by TSRL, Inc., consisting of a swellable microarray patch (MAP) or microneedle array patch that continuously delivers **zanamivir (ZAN)**, a neuraminidase inhibitor, over 5 days via transdermal administration. This approach addresses limitations of inhaled zanamivir (Relenza®), which is contraindicated in patients with respiratory compromise, by providing painless, self-administered systemic delivery with >60% bioavailability demonstrated in preclinical models (rats and minipigs). TSR-066 leverages a 505(b)(2) regulatory pathway, with FDA agreement on preclinical requirements, IND-enabling toxicology studies completed, and a Phase 1 pharmacokinetics, safety, and tolerability trial planned for 2H 2025 in healthy subjects.[1][2][4][7][10][15][19]