Mineralys lorundrostat sustained a 17.8 mmHg systolic drop through 48 weeks in open-label extension

Mineralys Therapeutics Inc. (Nasdaq: MLYS), based in Radnor, Pennsylvania, reported that its investigational hypertension drug lorundrostat sustained a 17.8 mmHg reduction in systolic blood pressure through 48 weeks, according to mychesco.com mychesco.commychesco.commychesco.comOpen source ↗. The data were presented Nov. 8 at the American Heart Association Scientific Sessions 2026 in Chicago. In the analysis, 56% of patients reached systolic pressure below 130 mmHg after nearly one year of treatment.

The FDA is reviewing lorundrostat for use alongside other antihypertensive medications in patients whose blood pressure remains uncontrolled despite treatment. The agency's decision is expected on Dec. 22, 2026.

Transform-HTN extension results

Transform-HTN is an open-label extension of the Phase 3 Launch-HTN trial. According to Mineralys, it is the largest long-term clinical evaluation of an aldosterone synthase inhibitor for hypertension to date. It enrolled 632 of the 808 patients assigned to lorundrostat groups in Launch-HTN. They received an additional 36 weeks of treatment while continuing their existing medications, and 583 of them (92%) completed 48 weeks of follow-up.

The efficacy analysis included 504 patients. It showed an average reduction of 17.8 mmHg in automated office systolic pressure from the Launch-HTN baseline, with a reported p-value below 0.0001 mychesco.commychesco.commychesco.comOpen source ↗. The reductions were similar in patients taking two background medications and in those taking three or more.

Because the extension was open-label, it does not establish a 48-week advantage over a concurrent placebo group. Participants had an average age of 61 years, 46% were women, and 63% had a body mass index of at least 30.

Safety, mechanism and regulatory status

Serious adverse events occurred in 27 patients (4.3%), and investigators classified two cases (0.3%) as treatment-related. Adverse events led 5.9% of patients to discontinue the drug, including 10 patients (1.6%) who stopped because of hyperkalemia. Hyperkalemia requiring a dose reduction, interruption or discontinuation occurred in 32 patients (5.1%).

Early increases in serum potassium and decreases in estimated glomerular filtration rate remained stable through Week 48. Mineralys reported no new clinically relevant safety findings compared with the original trial.

Lorundrostat inhibits CYP11B2, the enzyme that produces aldosterone. In laboratory testing it showed 374-fold selectivity for aldosterone synthase over cortisol synthase. Its observed half-life is 10 to 12 hours, and it reduced plasma aldosterone concentrations by 40% to 70% in patients with hypertension mychesco.commychesco.commychesco.comOpen source ↗.