Mineralys Therapeutics Receives FDA IND Clearance for Lorundrostat in Obstructive Sleep Apnea and Hypertension

MLYS
September 20, 2025
On January 9, 2025, Mineralys Therapeutics announced that the U.S. FDA cleared its Investigational New Drug (IND) Application for a Phase 2 clinical trial of lorundrostat. This trial is designed to evaluate lorundrostat for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in patients who also have hypertension. The company anticipates initiating this new Phase 2 trial in the first quarter of 2025. This regulatory clearance marks a strategic expansion of lorundrostat's development program into a third precision, targeted indication. Expanding into OSA and hypertension significantly broadens lorundrostat's potential market and addresses a condition strongly linked to resistant nocturnal hypertension. This move further positions Mineralys in the treatment of aldosterone-driven diseases. The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.