Mineralys lorundrostat cuts blood pressure and albuminuria in CKD

Mineralys Therapeutics has presented a new sub-group analysis from its pivotal Phase 3 Launch-HTN trial showing that lorundrostat, its investigational aldosterone synthase inhibitor, reduced blood pressure consistently in patients with and without chronic kidney disease, while also cutting a key marker of kidney damage in those with CKD.

The data were delivered in an oral presentation at the American Society of Nephrology Kidney Week 2026 in Denver by Liffert Vogt, Professor of Clinical Nephrology and Renal Physiology at Amsterdam University Medical Center.

Trial findings

At week 12, lorundrostat reduced placebo-adjusted systolic blood pressure by 9.6 mmHg in participants with CKD (p=0.0022) and by 12.2 mmHg in those without CKD (p less than 0.0001). Blood pressure reductions were detectable as early as week two in the CKD cohort. In both groups, lorundrostat more than doubled the proportion of participants reaching a target systolic blood pressure below 130 mmHg: 44% versus 18% with placebo in CKD patients, and 48% versus 22% in those without CKD.

Albuminuria, measured by the urine albumin-to-creatinine ratio, fell by 52.2% versus placebo at week 12 in CKD participants who had elevated protein at baseline (p less than 0.0001). The finding is broadly consistent with earlier results from the company's Explore-CKD trial, which demonstrated UACR reductions in patients with more severe albuminuria. Rates of confirmed hyperkalaemia, a concern common to drugs acting on the renin-angiotensin-aldosterone system, were low: 2.4% in the CKD group and zero in non-CKD participants.

"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 Dr Vogt.

Regulatory context and market backdrop

Lorundrostat is currently under FDA review for the treatment of uncontrolled hypertension in combination with existing antihypertensive drugs, with a PDUFA target action date of 22 December 2026. Approval, if granted, would make lorundrostat the first aldosterone synthase inhibitor to reach the US market in its class.

The CKD data carry commercial weight beyond the immediate hypertension indication. Approximately 37 million adults in the United States are estimated to have CKD, and up to 75% of those patients have uncontrolled hypertension, according to Mineralys. The convergence of the two conditions represents a large addressable population that existing drug classes have struggled to fully address.

The broader landscape for cardiorenal therapies has been transformed in recent years by the success of SGLT2 inhibitors, which carry regulatory approvals for both CKD and heart failure. Any aldosterone inhibitor seeking to carve out positioning in this space will need to demonstrate either complementary mechanism, superior tolerability, or utility in patients who are not candidates for or who have failed established agents. The Mineralys dataset does not yet include long-term renal outcome data, such as changes in estimated glomerular filtration rate or time to dialysis, which regulators and payers are likely to require before lorundrostat can be positioned as a CKD-modifying therapy in its own right.

Chief Medical Officer Terry Ferguson noted that aldosterone drives both conditions simultaneously, characterising lorundrostat's mechanism as addressing a common upstream cause. Mineralys said it has now completed six late-stage clinical trials of the compound.

The company has not disclosed plans for a formal CKD indication filing at this stage, and investors will be watching the December PDUFA date as the primary near-term catalyst.