Mineralys reports 46% blood pressure target achievement with lorundrostat 50 mg in Launch-HTN, alongside an 11.1 mmHg morning SBP reduction in Explore-OSA.
Written By: Aasritha Thippavajjala, PharmD
Reviewed By: Pharmacally Editorial Team
Mineralys Therapeutics reported new clinical findings for lorundrostat on October 9, 2026, highlighting blood pressure target achievement in the Phase 3 Launch-HTN trial and results from the Phase 2 Explore-OSA trial in adults with obstructive sleep apnea (OSA) and hypertension. The data were presented at the American Heart Association Hypertension Scientific Sessions 2026, held October 7–11 in Arlington, Virginia.
Lorundrostat is an investigational oral aldosterone synthase inhibitor that blocks CYP11B2, the enzyme responsible for aldosterone production. The drug is being developed for uncontrolled or treatment-resistant hypertension and related conditions associated with dysregulated aldosterone.
Launch-HTN: Blood Pressure Target Achievement
Launch-HTN (NCT06153693) was 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 the dose to 100 mg at Week 6 according to prespecified criteria, or placebo. The primary endpoint was the change from baseline in systolic blood pressure (SBP) at Week 6 compared with placebo, measured using automated office blood pressure monitoring.
In the new Week 12 analysis, 46% of participants receiving lorundrostat 50 mg achieved the guideline-recommended office SBP target of below 130 mmHg. The principal investigator, Manish Saxena, MBBS, also reported that 70% of lorundrostat-treated participants achieved an SBP reduction of at least 10 mmHg.
Saxena noted that a sustained SBP reduction of this magnitude is associated with a 20% reduction in cardiovascular-event risk. This estimate provides clinical context and was not a cardiovascular outcome measured in Launch-HTN.
Explore-OSA: Lower Morning Blood Pressure Without AHI Change
Explore-OSA (NCT06785454) was a randomized, double-blind, placebo-controlled crossover Phase 2 trial in overweight or obese adults with moderate-to-severe OSA and hypertension. Participants received lorundrostat 50 mg once daily in the evening and placebo during sequential treatment periods.
The primary endpoint was the change from baseline in the apnea-hypopnea index (AHI) after four weeks of active treatment compared with placebo. AHI measures the frequency of apneas and hypopneas during sleep.
At Week 4, morning SBP decreased by 11.1 mmHg with lorundrostat, compared with a 1.0 mmHg reduction with placebo. The reduction with lorundrostat was statistically significant (p<0.0001), whereas the placebo change was not statistically significant.
Despite the reduction in morning blood pressure, the company reported no measurable change in AHI. The findings therefore indicate a blood pressure effect without a demonstrated improvement in the trial’s primary sleep-apnea measure.
Mineralys described lorundrostat’s safety and tolerability profile in Explore-OSA as favorable, reporting no evidence of significant safety events, including hyperkalemia. However, the announcement did not provide detailed adverse-event counts.
Pharmacology and Regulatory Status
Mineralys reports that lorundrostat has 374-fold selectivity for aldosterone synthase over cortisol synthase in vitro, an observed half-life of 10–12 hours, and a 40–70% reduction in plasma aldosterone concentrations in participants with hypertension.
The company has reported completing six late-stage clinical trials, including the pivotal Launch-HTN and Advance-HTN studies. Lorundrostat remains investigational. Separately, Mineralys has reported that the U.S. Food and Drug Administration accepted its New Drug Application for hypertension, with a Prescription Drug User Fee Act target date of December 22, 2026.
The new analyses add information on blood pressure target achievement and morning blood pressure reduction. However, the Explore-OSA findings do not demonstrate an improvement in AHI, and the reported blood pressure changes should not be interpreted as evidence of reduced cardiovascular events in these trials.
Reference
Mineralys Therapeutics Presents New Data for Lorundrostat at the American Heart Association Hypertension Scientific Sessions 2026, Mineralys Therapeutics, 09 October 2026
Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension, ClinicalTrials.gov ID NCT06153693
A Study to Assess the Efficacy and Safety of Lorundrostat in Participants with Obstructive Sleep Apnea and Hypertension, ClinicalTrials.gov ID NCT06785454
About the Writer
Aasritha Thippavajjala (Linkedin) is a pharm D student and aspiring medical writer with medical writing, clinical training experience and a strong interest in clinical research and patient safety She has hands-on exposure to clinical pharmacy activities including medication profile assessment, clinical case review, identification of potential drug-related problems, ADR awareness, patient counselling, and clinical documentation. She has also gained experience in medical literature review, evidence synthesis, and scientific communication through her published review article on digital twin-based patient simulation and her poster presentation at the 74th Indian Pharmaceutical Congress. Certified in ICH Good Clinical Practice (E6(R3)) and Scientific Writing in Health Research, she is passionate about applying her clinical knowledge and research skills to medical writing ,clinical research and contributing to accurate, evidence-based healthcare.