RADNOR, PA — Mineralys Therapeutics Inc. (Nasdaq: MLYS) reported that its experimental hypertension drug lorundrostat sustained a 17.8 mmHg reduction in systolic blood pressure through 48 weeks, providing additional long-term clinical evidence ahead of a Dec. 22, 2026, Food and Drug Administration decision on the Radnor company’s proposed treatment for patients whose blood pressure remains uncontrolled despite medication.
The results, presented Nov. 8 at the American Heart Association Scientific Sessions 2026 in Chicago, showed that 56% of patients achieved systolic blood pressure below 130 mmHg after nearly one year of treatment.
The findings came from Transform-HTN, an open-label extension of the company’s Phase 3 Launch-HTN trial, and represent the largest long-term clinical evaluation of an aldosterone synthase inhibitor for hypertension to date, according to Mineralys.
Lorundrostat is under FDA review for use alongside other antihypertensive medications. The agency’s decision could determine whether the drug becomes an additional treatment option for patients who have difficulty controlling their blood pressure with existing therapies.
The 48-week results showed an average reduction of 17.8 mmHg in automated office systolic blood pressure from the original Launch-HTN baseline, a statistically significant change with a reported p-value below 0.0001.
The reductions were similar among patients taking two background blood pressure medications and those receiving three or more.
Manish Saxena, clinical co-director of Queen Mary University of London’s William Harvey Clinical Research Centre and a hypertension specialist at Barts Health NHS Trust, emphasized the importance of maintaining blood pressure control in patients already receiving multiple medications.
“In Transform-HTN, lorundrostat demonstrated sustained blood pressure reductions for nearly a year, with more than half of participants achieving the guideline-recommended systolic blood pressure target of less than 130 mmHg,” Saxena stated.
The extension enrolled 632 participants from the 808 patients assigned to lorundrostat treatment groups in Launch-HTN, a randomized, double-blind, placebo-controlled Phase 3 study.
Participants received an additional 36 weeks of lorundrostat after completing the initial 12-week trial while continuing their existing blood pressure medications.
Of the 632 participants, 583, or 92%, completed 48 weeks of follow-up.
The efficacy analysis included 504 patients, excluding those assigned to placebo during a four-week randomized treatment withdrawal substudy conducted between Weeks 24 and 28.
The safety analysis covered all 632 participants who received at least one dose of lorundrostat during the open-label extension.
The longer-term safety findings were generally consistent with those observed in Launch-HTN, although some patients experienced adverse events requiring treatment changes.
Serious adverse events occurred in 27 patients, or 4.3% of participants. Investigators classified two cases, representing 0.3%, as treatment-related.
Thirty-seven patients, or 5.9%, discontinued lorundrostat because of adverse events, including 10 patients, or 1.6%, who stopped treatment because of hyperkalemia, a condition involving elevated potassium levels in the blood.
Hyperkalemia requiring a dose reduction, treatment interruption or discontinuation occurred in 32 patients, or 5.1%.
Researchers also observed early increases in serum potassium and decreases in estimated glomerular filtration rate, a measure of kidney function. Both measures remained stable through Week 48.
The findings are relevant to lorundrostat’s mechanism of action because the drug inhibits aldosterone production, which affects blood pressure regulation, potassium balance and kidney function.
Mineralys reported no new clinically relevant safety findings during the 36-week extension compared with the original trial.
The study population included patients with several characteristics associated with elevated cardiovascular risk.
Participants had an average age of 61 years, and 46% were women. Black or African American patients represented 25% of the population, while Hispanic or Latino patients accounted for 39%.
Nearly two-thirds of participants, or 63%, had a body mass index of at least 30, meeting the threshold for obesity.
At baseline, 41% were taking two antihypertensive medications, while 59% were receiving three or more.
The initial open-label lorundrostat dose was 50 milligrams once daily, or 25 milligrams for patients whose previously blinded treatment dose had been reduced.
Transform-HTN is designed to evaluate longer-term safety, efficacy and tolerability among patients completing one of three eligible parent studies: Advance-HTN, Launch-HTN or Explore-CKD.
The results presented at the American Heart Association meeting specifically involved participants from the lorundrostat treatment groups in Launch-HTN.
That Phase 3 study enrolled adults whose hypertension remained uncontrolled despite treatment with two to five medications.
Patients were randomized to receive lorundrostat 50 milligrams daily, lorundrostat 50 milligrams with a potential increase to 100 milligrams at Week 6, or placebo.
Its primary endpoint measured the change in automated office systolic blood pressure at Week 6 compared with placebo.
The extension findings provide evidence of sustained blood pressure reductions but, because the longer-term treatment period was open-label, do not establish a 48-week treatment advantage over a concurrent placebo group.
Lorundrostat works by inhibiting CYP11B2, the enzyme responsible for producing aldosterone, a hormone that helps regulate blood pressure and electrolyte balance.
The investigational oral medication demonstrated 374-fold selectivity for aldosterone synthase inhibition compared with cortisol synthase inhibition in laboratory testing.
The drug has an observed half-life of 10 to 12 hours and produced reductions of 40% to 70% in plasma aldosterone concentrations among patients with hypertension.
Mineralys has completed six late-stage clinical trials involving lorundrostat, including the pivotal Phase 3 Launch-HTN and Phase 2 Advance-HTN studies supporting its regulatory application.
The company is also developing the drug for conditions associated with dysregulated aldosterone, including chronic kidney disease and obstructive sleep apnea.
Hypertension remains a major public health and economic burden in the United States.
More than 685,000 U.S. deaths in 2022 listed hypertension as a primary or contributing cause, according to figures cited by Mineralys. The annual economic burden of hypertension and related health problems was estimated at approximately $219 billion in 2019.
Fewer than half of patients with hypertension achieve their blood pressure goals using currently available medications, while dysregulated aldosterone is estimated to contribute to hypertension in approximately 30% of affected patients.
Jon Congleton, Mineralys’ chief executive officer, connected the long-term findings to the company’s pending regulatory review.
“As we advance toward a potential FDA approval, these findings further strengthen the evidence supporting lorundrostat as an important new treatment option,” Congleton stated.
The FDA’s Prescription Drug User Fee Act target date of Dec. 22 marks the next major regulatory milestone for lorundrostat, with the agency evaluating its use in combination with other blood pressure medications.
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