Mineralys Publishes Full Phase 2 Advance-HTN Study Results In NEJM, Highlighting Breakthrough In Hypertension Treatment

Mineralys Therapeutics, Inc., a clinical-stage biopharma company developing treatments for conditions linked to abnormal aldosterone levels—like high blood pressure, chronic kidney disease, and sleep apnea—has announced that the New England Journal of Medicine (NEJM) has published full results from its Phase 2 Advance-HTN trial.

The published study, titled “Lorundrostat Efficacy and Safety in Patients with Uncontrolled Hypertension,” appears in the April 23, 2025 issue of NEJM. The trial tested lorundrostat in people with uncontrolled or resistant hypertension. Results showed that a 50 mg dose of lorundrostat reduced 24-hour blood pressure by 15.4 mmHg overall, and by 7.9 mmHg more than placebo, after 12 weeks of treatment (p=0.001). The drug worked consistently across different groups—regardless of gender, race, or the number of medications patients were already taking.

Jon Congleton, Chief Executive Officer of Mineralys Therapeutics, mentioned, “The publication of our Advance-HTN trial results in the New England Journal of Medicine is a significant milestone that underscores both the strength of our clinical data and the potentially transformative nature of this new class of medicines that could help address dysregulated aldosterone, an unaddressed, key driver of hypertension. Prior studies have shown that even modest reductions in systolic blood pressure can lead to a substantial decrease in the incidence of major cardiovascular events. The blood pressure reductions with lorundrostat observed in the Advance-HTN trial are particularly meaningful given the well-established correlation between elevated blood pressure, dysregulated aldosterone production and cardiovascular risk.”

Luke Laffin, M.D., co-director of the Center for Blood Pressure Disorders in the Heart, Vascular & Thoracic Institute at Cleveland Clinic and the study’s lead author, commented, “The significant blood pressure lowering with lorundrostat 50 mg in the Advance-HTN trial was seen in patients treated by specialists who were taking an optimized standardized antihypertensive regimen – those patients with true uncontrolled or resistant hypertension that desperately need new options to lower their blood pressure. Currently available therapies to treat hypertension do not decrease aldosterone production in the body, and we know aldosterone dysregulation is a driving factor in the blood pressure elevation of many of our patients. The findings reinforce the critical role of aldosterone in the pathogenesis of hypertension and the potential of lorundrostat to address unmet medical needs facing patients with uncontrolled or treatment-resistant disease.”

Lorundrostat also showed a good safety profile, with only small changes in key health markers like potassium, sodium, and kidney function. This NEJM publication follows a late-breaking presentation at the American College of Cardiology’s 2025 conference in Chicago and builds on earlier positive topline results from both the Advance-HTN and Launch-HTN studies. Mineralys plans to share more data from the Phase 3 Launch-HTN trial soon and continues to collect long-term information in its ongoing Transform-HTN open-label study.