Innovative medication displays potential for tackling difficult cases of hypertension
New Drug Shows Promise in Treating Resistant Hypertension
A groundbreaking Phase III trial, known as Launch-HTN, has shown significant success in the treatment of treatment-resistant hypertension (rHTN) with the drug lorundrostat. The trial, conducted by researchers at the University of California San Diego School of Medicine, has demonstrated promising results in lowering systolic blood pressure for patients who have not responded to standard medications [1][2].
The 285-participant study, which focused on targeting aldosterone as a novel pathway for treating hypertension, was designed to investigate the impact of lorundrostat on lowering blood pressure in patients with rHTN. The trial was conducted in collaboration with the Cleveland Clinic Coordinating Center for Clinical Research [1].
After an initial three-week period during which all participants followed a standardized regimen of antihypertensive medication, 190 participants were assigned lorundrostat, while 95 received a placebo. The results were impressive, with the lorundrostat 25 mg dose achieving a 9.25 mmHg reduction in systolic blood pressure (SBP), compared to a 7.5 mmHg reduction for the placebo group at week four. These reductions were statistically significant (p = 0.0024) based on automated office blood pressure measurements [1].
The positive outcomes of the trial, which were published in the June 30, 2025 issue of the Journal of the American Medical Association (JAMA) and presented as a late-breaking presentation at the 2025 European Society of Hypertension Meeting in Milan, Italy, have led to plans for a larger Phase III trial to further assess lorundrostat's safety and effectiveness [1][2].
The trial featured a diverse patient group, potentially benefiting a broader population at risk for heart disease. Systolic blood pressure is a critical measure because high readings increase the risk of heart disease, the leading cause of death in the United States. Participants who received lorundrostat experienced an average drop of 15 millimeters of mercury (mmHg) in their systolic blood pressure, while those who received a placebo experienced an average drop of 7 points [1].
Lorundrostat works by halting the production of aldosterone, offering a new strategy for managing difficult-to-treat high blood pressure. The drug is part of a new class of aldosterone synthase inhibitors (ASIs) aimed at controlling hypertension by targeting aldosterone production, potentially reducing cardiovascular risk linked with resistant hypertension [1][4].
Mineralys Therapeutics, the company behind lorundrostat, is progressing toward regulatory submission, with a pre-New Drug Application (NDA) meeting with the FDA scheduled for the fourth quarter of 2025, signaling plans to advance toward potential market approval [1]. The positive findings from the Launch-HTN trial, as well as two other clinical trials of lorundrostat, further reinforce the drug’s favorable benefit-risk profile in this difficult-to-treat population [2].
Dr. Michael Wilkinson, the principal investigator for the study, found the results promising, despite some participants' blood pressure readings remaining elevated at the end of the trial [1]. The research team is now planning a larger Phase III trial to further investigate lorundrostat's safety and effectiveness.
[1] Mineralys Therapeutics. (2025). Press release: Mineralys Therapeutics Announces Positive Topline Results from Phase 3 Launch-HTN Trial of Lorundrostat in Participants with Uncontrolled and Treatment-Resistant Hypertension. Retrieved from https://mineralystx.com/news-events/press-releases/detail/186/mineralys-therapeutics-announces-positive-topline-results-from-phase-3-launch-htn-trial-of-lorundrostat-in-participants-with-uncontrolled-and-treatment-resistant-hypertension
[2] Mineralys Therapeutics. (2025). Presentation: Lorundrostat in Participants with Uncontrolled and Treatment-Resistant Hypertension. Retrieved from https://mineralystx.com/news-events/presentations/detail/185/presentation-lorundrostat-in-participants-with-uncontrolled-and-treatment-resistant-hypertension
[3] Mineralys Therapeutics. (2025). Press release: Mineralys Therapeutics Announces Positive Topline Results from Phase 3 Advance-HTN Trial of Lorundrostat in Participants with Uncontrolled Hypertension. Retrieved from https://mineralystx.com/news-events/press-releases/detail/184/mineralys-therapeutics-announces-positive-topline-results-from-phase-3-advance-htn-trial-of-lorundrostat-in-participants-with-uncontrolled-hypertension
[4] Mineralys Therapeutics. (2025). Fact sheet: Lorundrostat. Retrieved from https://mineralystx.com/pipeline/lorundrostat/
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