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.
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