Mineralys reports Phase 3 lorundrostat data showing blood pressure reductions in participants with and without CKD and a 52.2% UACR reduction in those with baseline albuminuria.
Written By: Sravani Pamanji, PharmD
Reviewed By: Pharmacally Editorial Team
Mineralys Therapeutics announced new clinical data for lorundrostat from the Phase 3 Launch-HTN trial at the American Society of Nephrology (ASN) Kidney Week 2026 on October 22, 2026. The analysis evaluated blood pressure outcomes in participants with hypertension, with and without chronic kidney disease (CKD). At Week 12, lorundrostat demonstrated placebo-adjusted systolic blood pressure (SBP) reductions of 9.6 mmHg in participants with CKD and 12.2 mmHg in those without CKD. Among participants with CKD and baseline albuminuria, treatment also reduced urine albumin-to-creatinine ratio (UACR) by 52.2% versus placebo.
The findings suggest that lorundrostat’s blood pressure-lowering effects extend to participants with mild-to-moderate CKD, while the albuminuria result provides an additional short-term biomarker signal. However, these findings do not establish long-term kidney protection.
Lorundrostat and the Launch-HTN Trial
Lorundrostat is an investigational, orally administered, selective aldosterone synthase inhibitor designed to reduce aldosterone production by inhibiting CYP11B2. Mineralys is developing the drug for uncontrolled or resistant hypertension and related conditions.
Launch-HTN (NCT06153693) is a global, randomized, double-blind, placebo-controlled Phase 3 trial involving adults whose blood pressure remained uncontrolled despite treatment with two to five antihypertensive medications.
Participants received lorundrostat 50 mg once daily, lorundrostat 50 mg once daily with the option to increase to 100 mg at Week 6 according to prespecified criteria, or placebo. The primary endpoint was the change from baseline in SBP at Week 6 versus placebo, measured using automated office blood pressure monitoring. The newly reported findings highlight Week 12 outcomes in participants with Stage 1–3 CKD and those without CKD.
Blood Pressure Outcomes Across CKD Subgroups
At Week 12, the placebo-adjusted SBP reduction was 9.6 mmHg among participants with CKD (p=0.0022) and 12.2 mmHg among those without CKD (p<0.0001). Among participants with CKD, blood pressure reductions were observed as early as Week 2.
A greater proportion of lorundrostat-treated participants also achieved an SBP below 130 mmHg at Week 12. Among those with CKD, 44% receiving lorundrostat reached this threshold, compared with 18% receiving placebo. Among participants without CKD, the corresponding proportions were 48% and 22%.
These results indicate blood pressure-lowering activity in both reported subgroups. However, the numerical difference between the SBP reductions does not establish that lorundrostat works differently according to CKD status. The announcement does not provide subgroup sample sizes or establish whether the difference in treatment effects was statistically significant.
Albuminuria Reduction and Safety Findings
Among participants with CKD and baseline albuminuria, lorundrostat reduced UACR by 52.2% versus placebo at Week 12 (p<0.0001). Mineralys stated that this finding adds to results from the earlier Explore-CKD trial, which also reported UACR reductions among participants with more severe albuminuria. The announcement did not provide detailed numerical results from Explore-CKD.
The UACR reduction is a potentially relevant finding because albuminuria is an important marker of kidney damage. Nevertheless, the short-term change does not demonstrate that lorundrostat slows CKD progression, preserves kidney function, or prevents kidney failure. Longer-term clinical outcomes are needed to determine whether this biomarker improvement translates into meaningful renal benefits.
Mineralys reported an acceptable safety profile in participants with and without CKD. Confirmed hyperkalemia occurred in 2.4% of participants with CKD and 0% of those without CKD. Because the announcement did not include a comprehensive breakdown of adverse events, these subgroup findings alone are insufficient to characterize the drug’s overall safety profile. Hyperkalemia remains an important safety consideration when evaluating aldosterone-lowering therapies.
Regulatory Status and Clinical Interpretation
Mineralys reported that lorundrostat was under review by the U.S. Food and Drug Administration for hypertension treatment in combination with other antihypertensive medications. The Prescription Drug User Fee Act (PDUFA) target date was December 22, 2026. The announcement did not report a regulatory decision, and lorundrostat remains investigational.
The Launch-HTN analysis supports further evaluation of lorundrostat as an add-on treatment for uncontrolled hypertension in people with and without Stage 1–3 CKD. The Week 12 SBP reductions, together with the improvement in UACR among participants with baseline albuminuria, provide complementary evidence of short-term activity.
However, the findings should not be interpreted as proof of kidney protection or cardiovascular risk reduction. The available announcement also leaves uncertainty about subgroup sizes, comparative treatment effects and the broader safety profile. Further evidence will be needed to establish the durability of these effects and determine whether the observed changes translate into improved long-term kidney or cardiovascular outcomes.
Reference
Mineralys Therapeutics Presents New Lorundrostat Data in Participants with Hypertension and Chronic Kidney Disease at ASN Kidney Week 2026, Mineralys Therapeutics, 22 October 2026
Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension, ClinicalTrials.gov ID NCT06153693
About the Writer
Sravani Pamanji is a PharmD (LinkedIn) professional with experience in scientific writing, medical literature review, drug profile preparation, and clinical case documentation. She has contributed to scientific publication and presented at the 74th Indian Pharmaceutical Congress. Her training includes ICH GCP E6(R3), scientific research, and medication safety. She is passionate about evidence-based medical communication and accurate dissemination of clinical and pharmaceutical information.