Lorundrostat - (Launch-HTN)

October 9, 2026: Mineralys Therapeutics (NASDAQ: MLYS) reported new lorundrostat data at the American Heart Association Hypertension Scientific Sessions 2026.

Launch-HTN (Phase 3, uncontrolled/treatment-resistant hypertension): a new analysis showed 46% of participants receiving lorundrostat 50 mg reached the AHA/ACC office systolic blood pressure target of <130 mmHg at Week 12, and 70% achieved at least a 10 mmHg systolic BP reduction. The pivotal trial enrolled adults uncontrolled on two to five antihypertensive drugs; the primary endpoint was change in systolic BP at 6 weeks versus placebo.

Explore-OSA (Phase 2, overweight/obese adults with moderate-to-severe obstructive sleep apnea and hypertension): final results showed lorundrostat 50 mg once daily in the evening reduced morning systolic BP by 11.1 mmHg at Week 4 (p<0.0001) versus a 1.0 mmHg reduction with placebo (p=NS). No measurable change was seen in apnea-hypopnea index, the primary endpoint. Mineralys said lorundrostat had a favorable safety/tolerability profile with no evidence of significant safety events, including hyperkalemia.

The release also states Mineralys has an accepted NDA for lorundrostat, but no FDA action date was provided.