MLYS

The obstructive sleep apnea (OSA) therapeutic landscape is rapidly expanding with 18+ companies developing 22+ pipeline drugs across multiple mechanisms of action. Eli Lilly's ZEPBOUND (tirzepatide) became the first FDA-approved pharmacological treatment for OSA in December 2024. Other major players including Apnimed, Amgen, Mosanna Therapeutics, and Incannex Healthcare are advancing late-stage candidates targeting weight loss, neuromuscular function, and airway control through diverse delivery methods.

Mineralys Therapeutics presented positive Phase 3 Launch-HTN trial data showing lorundrostat achieved significant blood pressure reductions in participants with and without chronic kidney disease, with a 52% reduction in albuminuria in CKD patients. The drug demonstrated an acceptable safety profile with low hyperkalemia rates and is under FDA review with a PDUFA target date of December 22, 2026.

Mineralys Therapeutics presented new clinical trial data for lorundrostat, its investigational aldosterone synthase inhibitor for treating difficult-to-treat hypertension. The Launch-HTN trial showed 46% of participants achieved AHA/ACC guideline systolic blood pressure targets (<130 mmHg) at 12 weeks, with over two-thirds achieving ≥10 mmHg reduction. The Explore-OSA trial demonstrated clinically meaningful morning blood pressure reductions in obstructive sleep apnea patients with no adverse effects on sleep apnea indices.