Key Facts
- Lorundrostat: aldosterone synthase inhibitor
- Population: hypertension with CKD
- Trial: phase 3 Launch-HTN post hoc analysis
- Week 12 SBP: −9.6 mm Hg vs placebo in CKD
- FDA PDUFA: December 22, 2026
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Lorundrostat Lowers BP, Albuminuria in Phase 3 CKD Hypertension Analysis
Phase 3 post hoc data linked lorundrostat to lower systolic blood pressure and albuminuria in patients with hypertension and CKD.
According to post hoc data from the phase 3 Launch-HTN trial, lorundrostat was associated with lower systolic blood pressure (SBP) and reduced albuminuria among participants with hypertension and chronic kidney disease (CKD).1
Lorundrostat is an investigational, orally administered aldosterone synthase inhibitor under review by the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act target action date of December 22, 2026. The agent is being developed for uncontrolled or resistant hypertension and related aldosterone-driven comorbidities, including CKD. The present findings were presented at the 35th European Meeting on Hypertension and Cardiovascular Protection in Gdańsk, Poland.1
“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,” Liffert Vogt, MD. PhD, professor of nephrology and renal transplantation at Amsterdam University Medical Center and University of Amsterdam, said in a statement. “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.”1
The Launch-HTN CKD Analysis
Launch-HTN was a global, randomized, double-blind, placebo-controlled phase 3 trial enrolling adults whose blood pressure remained uncontrolled despite treatment with 2-5 antihypertensive medications. Participants were assigned to placebo, lorundrostat 50 mg once daily, or lorundrostat 50 mg once daily with optional uptitration to 100 mg at week 6. The primary endpoint was change from baseline in SBP at 6 weeks versus placebo, measured by automated office blood pressure monitoring.1,2
The post hoc analysis presented at ESH 2026 evaluated once-daily lorundrostat 50 mg by CKD status among 800 participants with uncontrolled or resistant hypertension. Of these, 192 participants had CKD. The CKD subgroup appeared to have more difficult-to-treat hypertension at baseline: 71% were receiving 3 or more antihypertensive medications, compared with 56% of participants without CKD. Baseline SBP of at least 160 mm Hg was reported in 31% of participants with CKD and 17% of those without CKD.1
At week 12, placebo-adjusted SBP reductions with lorundrostat were 9.6 mm Hg among participants with CKD (P = .0022) and 12.2 mm Hg among participants without CKD (P <.0001). A larger proportion of lorundrostat-treated participants reached SBP less than 130 mm Hg compared with placebo in both subgroups: 44% vs 18% among those with CKD and 48% vs 22% among those without CKD.1
Among 84 participants with CKD and baseline albuminuria, lorundrostat was associated with a 52.2% placebo-adjusted reduction in urinary albumin-to-creatinine ratio at 12 weeks (P <.0001). Albuminuria reduction is a relevant intermediate kidney measure in CKD studies, although the analysis did not report longer-term kidney outcomes.1
Lorundrostat Safety and Mechanism in Hypertension
Mineralys reported a favorable safety profile over 12 weeks in participants with and without CKD. Confirmed hyperkalemia occurred in 2.4% of participants with CKD and 0% of participants without CKD, according to the company.1
Lorundrostat is designed to inhibit CYP11B2, the enzyme responsible for aldosterone production. Mineralys described the drug as selective for aldosterone synthase inhibition relative to cortisol synthase inhibition in vitro, with an observed half-life of 10 to 12 hours and reductions in plasma aldosterone concentration in hypertensive participants.1
Aldosterone-targeted approaches remain of interest in resistant hypertension because mineralocorticoid receptor activation contributes to sodium retention and vascular effects. Current hypertension and CKD guidance emphasizes standardized BP measurement, individualized BP targets, and use of established therapies including renin-angiotensin system inhibition when clinically appropriate.3,4
Remaining Questions
The company stated lorundrostat is under FDA review for uncontrolled or resistant hypertension. If approved, the final indication, monitoring recommendations, contraindications, and safety language would be determined by FDA review.1
“Despite the availability of current therapies, up to 75% 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,” Jon Congleton, chief executive officer of Mineralys Therapeutics, said in a statement. “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.”1
References
Mineralys Therapeutics. Mineralys Therapeutics presents new data from the phase 3 Launch-HTN trial of lorundrostat in participants with hypertension and chronic kidney disease at European Meeting on Hypertension and Cardiovascular Protection (ESH 2026). Published May 30, 2026. https://www.globenewswire.com/news-release/2026/05/30/3303889/0/en/mineralys-therapeutics-presents-new-data-from-the-phase-3-launch-htn-trial-of-lorundrostat-in-participants-with-hypertension-and-chronic-kidney-disease-at-european-meeting-on-hyper.html
Mineralys Therapeutics. Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension. ClinicalTrials.gov Identifier: NCT06153693. Updated May 1, 2026. Accessed June 2, 2026. https://clinicaltrials.gov/study/NCT06153693
Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71(6):1269-1324. doi:10.1161/HYP.0000000000000066
Kidney Disease: Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease. Kidney Int. 2021;99(3S):S1-S87. doi:10.1016/j.kint.2020.11.003
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