Phase III LAUNCH-HTN data for Mineralys’ lorundrostat

US biopharma company Mineralys Therapeutics (Nasdaq: MLYS), which is focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today presented new clinical data for lorundrostat at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026) in Gdańsk, Poland.

“Despite the availability of current therapies, up to 75 percent of patients with chronic kidney disease still have uncontrolled or resistant blood pressure, contributing to a high risk of cardiovascular events and kidney disease progression,” said Jon Congleton, chief executive of Mineralys Therapeutics. “These results, together with our Explore-CKD trial findings, demonstrate lorundrostat’s potential to address the compounded burden of hypertension and CKD, underscoring its promise as an important potential treatment option for this difficult-to-treat population with high unmet need,” he noted.

Key study findings

The analysis evaluated the efficacy and safety of once-daily lorundrostat 50mg by CKD status among 800 participants with uncontrolled or resistant hypertension enrolled in the randomized, double-blind, placebo-controlled Phase III Launch-HTN trial. Among participants with CKD (n=192), 71% were receiving three or more anti-hypertensive medications at baseline, compared with 56% of those without CKD. In addition, 31% of participants with CKD had systolic blood pressure (SBP) ≥160 mmHg at baseline, versus 17% of participants without CKD.

Lorundrostat demonstrated significant reductions in SBP that were comparable between CKD and non-CKD participants. At week 12, placebo-adjusted SBP reductions were 9.6 mmHg in participants with CKD (p=0.0022) and 12.2 mmHg in those without CKD (p<0.0001). A greater proportion of lorundrostat-treated participants also achieved target SBP of <130 mmHg at week 12 compared with placebo, both among CKD participants (44% vs 18%) and non-CKD participants (48% versus 22%).

Lorundrostat treatment was also associated with a significant placebo-adjusted reduction in urinary albumin-to-creatinine ratio (UACR) among 84 participants with CKD and baseline albuminuria, achieving a 52.2% placebo-adjusted reduction at 12 weeks (p<0.0001). Lorundrostat had a favorable safety profile in both CKD and non-CKD participants with low rates of confirmed hyperkalemia, 2.4% and 0% respectively.

Market opportunity

The global hypertension treatment market is currently valued between $34 billion and $46 billion, depending on the therapeutic scope analyzed. Driven by an aging population and rising rates of cardiovascular disease, the sector is projected to reach between $47 billion and $69 billion by 2032–2033.

“These findings are compelling because they show that lorundrostat achieves comparable blood pressure reductions regardless of kidney disease status, while also significantly reducing albuminuria, a key marker of kidney injury and disease progression, in these patients,” said Dr Liffert Vogt, Professor of Nephrology and Renal Transplantation at Amsterdam University Medical Center and University of Amsterdam, adding: “Aldosterone is a key driver of both chronic kidney disease and difficult-to-treat hypertension, and these findings demonstrate the potential for lorundrostat to provide needed cardiorenal protection for these patients.”