RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) said its Phase 3 Launch-HTN clinical trial evaluating lorundrostat was selected by JAMA editors as one of the most impactful medical studies of 2025, placing the hypertension research among a short list of nine studies highlighted in the journal’s inaugural Research of the Year Roundup.
The recognition covers studies published between October 2024 and September 2025 that JAMA editors deemed most important to patients, clinicians, and public health. The selected research spans multiple disciplines, including dementia, artificial intelligence, and cardiovascular disease. Mineralys’ trial was featured under the heading “New Hope for Treatment-Resistant Hypertension.”
Launch-HTN is the largest clinical trial to date of an aldosterone synthase inhibitor in patients with uncontrolled or treatment-resistant hypertension. The study enrolled 1,083 participants already receiving background antihypertensive therapy and evaluated the efficacy and safety of lorundrostat, a once-daily oral therapy designed to reduce excess aldosterone production.
Unlike existing therapies that block aldosterone at the receptor level, lorundrostat inhibits the enzyme responsible for producing the hormone itself. JAMA highlighted this mechanism as a key differentiator, targeting what researchers describe as a root driver of hypertension.
According to the published results, lorundrostat 50 milligrams produced statistically significant and clinically meaningful reductions in systolic blood pressure. At six weeks, patients experienced a 16.9 mmHg reduction in automated office blood pressure, compared with placebo-adjusted reductions of 9.1 mmHg. Blood pressure lowering was sustained through week 12, with a 19.0 mmHg reduction and an 11.7 mmHg placebo-adjusted difference. The effects were consistent across age, sex, race, body mass index, and baseline treatment regimens.
JAMA editors also pointed to the trial’s diverse enrollment, including a high proportion of women, Black or African American participants, and older adults, groups that are often underrepresented in late-stage cardiovascular trials.
Safety findings showed higher rates of hyponatremia, hyperkalemia, and reduced kidney function in the treatment group, but discontinuation due to adverse events remained below 1 percent, which the journal described as favorable given the severity of disease in the study population.
In commentary accompanying the roundup, JAMA Executive Editor Gregory Curfman, MD, said lorundrostat opens a new treatment pathway for patients whose blood pressure remains uncontrolled despite multiple medications, a population that may account for as many as 40 percent of people with hypertension and faces elevated risks of heart attack, stroke, and kidney disease.
Mineralys Chief Executive Officer Jon Congleton said the recognition underscores the unmet need in hypertension care and reflects the work of trial investigators and participants. He said the results reinforce the company’s strategy of addressing hypertension by targeting its biological drivers.
The Launch-HTN manuscript, titled “Lorundrostat in Participants with Uncontrolled and Treatment-Resistant Hypertension,” appeared in JAMA’s June 30, 2025, issue. Mineralys is continuing to evaluate the drug in the Transform-HTN open-label extension study and recently completed enrollment in Explore-OSA, a trial examining lorundrostat in patients with hypertension and moderate-to-severe obstructive sleep apnea. Data from that study are expected in the first quarter of 2026.
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