Mineralys Therapeutics has reported Phase 3 data showing lorundrostat reduced blood pressure and albuminuria in participants with hypertension and chronic kidney disease.

Blood pressure reductions in participants with CKD

Mineralys Therapeutics has reported new clinical data for lorundrostat, an investigational aldosterone synthase inhibitor, showing significant blood pressure reductions in participants with hypertension, including those with chronic kidney disease (CKD).

The analysis of the Phase 3 Launch-HTN trial found that lorundrostat reduced systolic blood pressure by 9.6 mmHg compared with placebo at week 12 in participants with CKD. Among participants without CKD, the placebo-adjusted reduction was 12.2 mmHg.

Both reductions were statistically significant. The results were consistent across CKD stages 1 to 3, and blood pressure reductions in participants with CKD were observed as early as week 2.

At week 12, 44% of participants with CKD receiving lorundrostat achieved a systolic blood pressure below 130 mmHg, compared with 18% receiving placebo. Among participants without CKD, the corresponding proportions were 48% and 22%.

The findings were presented at the American Society of Nephrology’s Kidney Week 2026 meeting.

Lorundrostat is designed to inhibit CYP11B2, the enzyme responsible for producing aldosterone. This hormone regulates sodium retention and blood pressure, while excess aldosterone can contribute to cardiovascular and kidney damage.

The drug is being developed for uncontrolled and resistant hypertension, including in patients whose blood pressure remains elevated despite treatment with existing antihypertensive medicines.

Lorundrostat reduces albuminuria

In participants with CKD who had albuminuria at baseline, lorundrostat reduced the urine albumin-to-creatinine ratio (UACR) by 52.2% compared with placebo at week 12. The result was statistically significant, with a p-value below 0.0001.

Albuminuria refers to the presence of albumin, a protein, in the urine. Elevated levels can indicate kidney damage and are associated with an increased risk of kidney and cardiovascular complications.

The finding builds on results from Mineralys’ earlier Explore-CKD trial, which also reported reductions in albuminuria among participants with established CKD.

However, the reduction in this marker over 12 weeks does not establish that lorundrostat slows the progression of kidney disease or prevents kidney failure. Longer-term studies will be needed to determine whether the changes translate into improved clinical outcomes.

Liffert Vogt, professor of clinical nephrology and renal physiology at Amsterdam University Medical Center and the University of Amsterdam, said: “These results are encouraging. Besides impacting blood pressure in participants with and without kidney disease, treatment with lorundrostat showed a meaningful reduction in albuminuria, a key marker for cardiovascular and kidney risk control.”

He added: “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.”

FDA decision expected in December

The Launch-HTN study was a global, randomised, double-blind, placebo-controlled Phase 3 trial involving adults whose hypertension remained uncontrolled despite treatment with two to five antihypertensive medicines.

Participants received lorundrostat at 50 mg once daily, lorundrostat at 50 mg with the option to increase the dose to 100 mg at week 6, or placebo. The primary endpoint was the change in systolic blood pressure at week 6, measured using automated office blood pressure monitoring.

The new CKD analysis reports blood pressure and albuminuria outcomes at week 12.

Mineralys said lorundrostat had an acceptable safety profile in participants with and without CKD. Confirmed hyperkalaemia, a potentially serious increase in blood potassium levels, occurred in 2.4% of participants with CKD and none of those without CKD.

The company is awaiting an FDA decision on lorundrostat for the treatment of hypertension in combination with other antihypertensive medicines. The Prescription Drug User Fee Act target date is 22 December 2026.

If approved, lorundrostat would provide another treatment option for people whose blood pressure remains uncontrolled despite existing medicines. Its potential benefits for patients with CKD will depend on further evidence establishing whether its effects on blood pressure and albuminuria translate into improved long-term kidney and cardiovascular outcomes.