RADNOR, PA — Mineralys Therapeutics Inc. (Nasdaq: MLYS) reported that its experimental hypertension drug lorundrostat reduced a key marker of kidney damage by 52.2% compared with placebo in patients with chronic kidney disease, strengthening the drug’s clinical profile ahead of a December 22 decision deadline from U.S. regulators.
The Radnor-based biotechnology company presented the findings from its Phase 3 Launch-HTN trial at the American Society of Nephrology’s Kidney Week 2026 conference in Denver.
The analysis found that lorundrostat significantly reduced systolic blood pressure in patients with and without chronic kidney disease, or CKD, suggesting its blood pressure-lowering effects extend to patients with impaired kidney function.
At 12 weeks, patients with CKD receiving lorundrostat experienced a placebo-adjusted systolic blood pressure reduction of 9.6 millimeters of mercury, compared with 12.2 mmHg among participants without CKD.
Both reductions were statistically significant. Among patients with CKD, blood pressure improvements were observed as early as the second week of treatment.
The proportion of CKD patients reaching a systolic blood pressure below 130 mmHg was 44% in the lorundrostat group, compared with 18% receiving placebo.
Among participants without CKD, 48% of lorundrostat-treated patients reached that target, compared with 22% in the placebo group.
The kidney-related findings provide an additional potential clinical benefit beyond blood pressure control.
Among participants with CKD and albuminuria at baseline, lorundrostat reduced the urine albumin-to-creatinine ratio by 52.2% relative to placebo at week 12, a statistically significant result.
Albuminuria, the presence of elevated albumin in urine, is an indicator of kidney damage and is associated with increased cardiovascular and kidney disease risk.
The findings were consistent with results from Mineralys’ earlier Explore-CKD trial, which demonstrated reductions in albuminuria among patients with more severe elevations of the marker.
“In patients with chronic kidney disease, high blood pressure and albuminuria are two of the most important risk factors we can modify, and lorundrostat improved both in this trial,” said Liffert Vogt, professor of clinical nephrology and renal physiology at Amsterdam University Medical Center and the University of Amsterdam.
Vogt presented the findings at the conference.
The results do not establish that lorundrostat prevents kidney failure or slows long-term disease progression. The reported kidney-related benefit was measured through changes in albuminuria over 12 weeks.
Mineralys also reported low rates of confirmed hyperkalemia, a potentially serious elevation of potassium in the blood.
The condition occurred in 2.4% of lorundrostat-treated participants with CKD and none of those without CKD. The company characterized the drug’s overall safety profile as acceptable in both groups.
Lorundrostat is an oral aldosterone synthase inhibitor designed to reduce production of aldosterone, a hormone involved in regulating blood pressure and fluid balance.
Excess aldosterone can contribute to sodium retention, vascular inflammation and kidney injury, making it a potential treatment target for patients whose hypertension remains uncontrolled despite multiple medications.
The Launch-HTN trial was a global, randomized, double-blind, placebo-controlled Phase 3 study involving adults whose blood pressure remained uncontrolled while taking two to five antihypertensive medications.
Participants received either lorundrostat at 50 milligrams daily, a 50-milligram dose with the option to increase to 100 milligrams after six weeks, or placebo.
The trial’s primary endpoint was the change in systolic blood pressure at six weeks compared with placebo.
The new analysis examined treatment responses among participants with and without CKD, including those with stages 1 through 3 kidney disease.
Mineralys is awaiting a U.S. Food and Drug Administration decision on lorundrostat for treating hypertension in combination with other blood pressure medications.
The FDA has established a Prescription Drug User Fee Act target date of December 22, 2026, for completing its review.
The pending application concerns hypertension treatment, not a separate approval for chronic kidney disease.
Mineralys has completed six late-stage clinical trials of lorundrostat, including the Launch-HTN and Advance-HTN studies supporting its regulatory submission.
The company is also investigating the drug’s potential in conditions associated with excessive aldosterone activity, including chronic kidney disease and obstructive sleep apnea.
According to estimates cited by Mineralys, approximately 37 million U.S. adults have chronic kidney disease, and as many as 75% of patients with CKD have uncontrolled hypertension.
The overlap between the conditions increases cardiovascular risk and complicates treatment, particularly for patients who do not achieve adequate blood pressure control with existing medications.
The December FDA decision will determine whether lorundrostat can enter the U.S. market as an additional treatment option for patients with hypertension.
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