Mineralys Therapeutics Achieves Phase 3 Albuminuria and Blood Pressure Data for Lorundrostat in CKD Patients

With a PDUFA date of December 22, 2026 already on the calendar, Mineralys Therapeutics has added a clinically significant data layer to its lorundrostat NDA package, Phase 3 evidence that the aldosterone synthase inhibitor reduces both systolic blood pressure and albuminuria in patients with concurrent hypertension and chronic kidney disease.

Data presented at ASN Kidney Week 2026 in Denver drew from the pivotal Launch-HTN trial (NCT06153693), a global, randomized, double-blind, placebo-controlled study enrolling adults with uncontrolled blood pressure on two to five antihypertensive agents. In the CKD subpopulation, lorundrostat reduced placebo-adjusted systolic blood pressure by 9.6 mmHg at week 12 (p=0.0022), consistent with the 12.2 mmHg reduction observed in participants without CKD (p<0.0001). Target SBP below 130 mmHg was reached in 44% of lorundrostat-treated CKD participants versus 18% on placebo.

The albuminuria finding carries particular weight for nephrology-focused regulatory reviewers. Among CKD participants with baseline albuminuria, lorundrostat reduced urine albumin-to-creatinine ratio by 52.2% versus placebo at week 12 (p<0.0001). That result reinforces earlier data from the Explore-CKD trial, which demonstrated UACR reductions in patients with more advanced albuminuria, strengthening the consistency argument across disease severity strata.

For QA and pharmacovigilance leads, the safety profile warrants attention. Confirmed hyperkalemia, a known class risk with agents targeting the renin-angiotensin-aldosterone axis, occurred in 2.4% of CKD participants and 0% of non-CKD participants, rates the company characterizes as acceptable. Lorundrostat is dosed at 50 mg once daily, with an option to escalate to 100 mg at week six under prespecified criteria.

Regulatory affairs teams tracking emerging therapeutic classes should note that lorundrostat, if approved, would represent the first aldosterone synthase inhibitor to reach the U.S. market for hypertension. The FDA is currently reviewing the NDA for lorundrostat in combination with other antihypertensive drugs; the agency's decision window closes on December 22, 2026.

The consistency of blood pressure outcomes across CKD Stages 1 through 3, combined with the UACR reduction data, positions the Launch-HTN dataset as a substantive addition to the submission dossier ahead of that action date.

Source: Mineralys Therapeutics, Inc. via GlobeNewswire, October 22, 2026.