RADNOR, PA — Mineralys Therapeutics (Nasdaq: MLYS) reported new Phase 3 data suggesting its experimental hypertension treatment lorundrostat may provide benefits for patients with chronic kidney disease, a finding that could broaden the drug’s clinical and commercial potential as it awaits a U.S. regulatory decision later this year.
The company presented the results at the European Meeting on Hypertension and Cardiovascular Protection in Poland, highlighting a post hoc analysis of its pivotal Launch-HTN trial involving patients with uncontrolled or resistant hypertension.
Among 192 participants with chronic kidney disease, lorundrostat produced a placebo-adjusted reduction in systolic blood pressure of 9.6 mmHg after 12 weeks. Participants without chronic kidney disease experienced a placebo-adjusted reduction of 12.2 mmHg.
The findings suggest the drug’s blood-pressure-lowering effects remained consistent regardless of kidney disease status, an important consideration because patients with chronic kidney disease often have more difficult-to-control hypertension and elevated cardiovascular risk.
The analysis also identified potential kidney-related benefits.
Among 84 participants with chronic kidney disease and baseline albuminuria, a condition characterized by excess protein in the urine and commonly used as a marker of kidney damage, treatment with lorundrostat produced a 52.2% placebo-adjusted reduction in urine albumin-to-creatinine ratio after 12 weeks.
A greater proportion of treated patients reached target systolic blood pressure levels below 130 mmHg compared with placebo. Among participants with chronic kidney disease, 44% achieved that target versus 18% in the placebo group. Among participants without chronic kidney disease, the rates were 48% and 22%, respectively.
Safety outcomes were generally similar across patient groups.
The company reported confirmed hyperkalemia, or elevated potassium levels, in 2.4% of participants with chronic kidney disease receiving lorundrostat and no confirmed cases among participants without chronic kidney disease.
The data arrive as Mineralys seeks approval for lorundrostat in the treatment of uncontrolled or resistant hypertension.
The drug is currently under review by the U.S. Food and Drug Administration, which has assigned a Prescription Drug User Fee Act target action date of December 22, 2026.
Launch-HTN enrolled 800 patients whose blood pressure remained uncontrolled despite treatment with two to five antihypertensive medications. Participants were randomized to receive placebo or lorundrostat and were followed for changes in systolic blood pressure.
Chronic kidney disease affects an estimated 37 million Americans, according to data cited by the company from the Centers for Disease Control and Prevention. The condition frequently occurs alongside hypertension, increasing the risk of cardiovascular complications, kidney failure, dialysis, and mortality.
Mineralys is developing lorundrostat to target dysregulated aldosterone, a hormone increasingly viewed as a contributor to both resistant hypertension and chronic kidney disease progression.
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