Lorundrostat Lowers BP, Albuminuria in CKD With Uncontrolled Hypertension

Lorundrostat, a highly selective aldosterone synthase inhibitor (ASI), produced similar placebo-adjusted reductions in systolic blood pressure in patients with and without chronic kidney disease (CKD) and lowered albuminuria by 52.2% in those with baseline albuminuria, according to a subgroup analysis of the phase 3 Launch-HTN trial.1

Liffert Vogt, MD, PhD, Professor of Clinical Nephrology and Renal Physiology at Amsterdam University Medical Center and the University of Amsterdam, presented the findings at ASN Kidney Week 2026 in Denver, Colorado, and Mineralys Therapeutics announced the results.1,2

“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,” Vogt said in a press release.2 “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.”

In the overall Launch-HTN population, lorundrostat 50 mg reduced automated office systolic blood pressure (AOSBP) by 9.1 mm Hg versus placebo at week 6 and 11.7 mm Hg at week 12.3 In the earlier phase 2 Explore-CKD trial, lorundrostat lowered AOSBP by 7.5 mm Hg and albuminuria by 25.6% compared with placebo in adults with CKD already receiving a renin-angiotensin system inhibitor and an SGLT2 inhibitor.4

How Did Lorundrostat Affect Blood Pressure in Patients With CKD?

The analysis included 808 participants with uncontrolled hypertension receiving > 2 antihypertensive medications, randomized to once-daily lorundrostat 50 mg (n = 538) or placebo (n = 270).1 CKD was defined as an eGFR < 60 mL/min/1.73 m² or a urine albumin-to-creatinine ratio (UACR) ≥ 30 mg/g, and investigators examined AOSBP changes across CKD stages 1 to 3. The trial’s primary end point was the change in AOSBP versus placebo at week 6.2

At week 12, placebo-adjusted AOSBP reduction was 9.6 mm Hg in participants with CKD (P = .0022) and 12.2 mm Hg in those without CKD (P <.0001).¹,² According to Mineralys, reductions in participants with CKD appeared as early as week 2 and were consistent across stages 1 to 3.2

Among participants with CKD, 44% receiving lorundrostat reached systolic blood pressure < 130 mm Hg at week 12, compared with 18% receiving placebo. In participants without CKD, the corresponding rates were 48% with lorundrostat and 22% with placebo.2

What Were the Albuminuria, Potassium, and eGFR Findings With Lorundrostat?

In participants with baseline albuminuria, the placebo-adjusted percent change in geometric mean UACR at week 12 was −52.2% (95% CI, −64.0% to −36.6%; P < .001).¹ Confirmed serum potassium above 6.0 mmol/L occurred in 3 participants (2.4%) with CKD receiving lorundrostat and in none without CKD.1

Among participants receiving lorundrostat, mean cystatin C–based eGFR decreased by 7.3, 4.0, and 4.2 mL/min/1.73 m² in those with CKD stages 1, 2, and 3, respectively. This compared with a decrease of 2.1 mL/min/1.73 m² in participants without CKD. The investigators characterized the safety profile as acceptable in patients with and without CKD.1

“CKD affects approximately 37 million adults in the U.S., and up to 75% of patients with CKD have uncontrolled hypertension. Aldosterone is a common driver of both hypertension and CKD, and lorundrostat is designed to reduce aldosterone at the source,” said Terry Ferguson, MD, Chief Medical Officer of Mineralys Therapeutics.2 “In Launch-HTN, lorundrostat provided similar blood pressure reductions in participants with or without CKD, and it not only did so across a broad spectrum of the disease, but it did it in a way that reduced albuminuria.”

Lorundrostat is under FDA review for the treatment of hypertension in combination with other antihypertensive agents, with a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026. Mineralys described plans to continue developing the agent for related conditions, including CKD and obstructive sleep apnea.2

References

1. Vogt L, Heagerty PJ, Bhaduri S. Blood pressure and albuminuria reduction with lorundrostat in CKD stages 1 to 3 in the Launch-HTN trial. Presented at: ASN Kidney Week 2026; October 21-25, 2026; Denver, CO. doi:10.1681/ASN.2026fy6zb248

2. Mineralys Therapeutics. Mineralys Therapeutics presents new lorundrostat data in participants with hypertension and chronic kidney disease at ASN Kidney Week 2026. GlobeNewswire. Published October 22, 2026. Accessed October 23, 2026. https://www.globenewswire.com/news-release/2026/10/22/3386983/0/en/mineralys-therapeutics-presents-new-lorundrostat-data-in-participants-with-hypertension-and-chronic-kidney-disease-at-asn-kidney-week-2026.html

3. Iapoce C. Lorundrostat significantly lowers blood pressure in key hypertension trials. HCPLive. Published March 10, 2025. Accessed October 23, 2026. https://www.hcplive.com/view/lorundrostat-significantly-lowers-blood-pressure-in-key-hypertension-trials

4. Beyond hypertension: lorundrostat’s potential to protect kidney function, with Matthew Weir, MD. HCPLive. Published November 12, 2025. Accessed October 23, 2026. https://www.hcplive.com/view/beyond-hypertension-lorundrostat-potential-protect-kidney-function-weir