WILMINGTON, DE — New data from the BaxHTN Phase III trial indicate that baxdrostat, an investigational aldosterone synthase inhibitor, achieved significant reductions in systolic blood pressure among patients with uncontrolled and resistant hypertension. Results were presented at the European Society of Cardiology Congress 2025 and simultaneously published in the New England Journal of Medicine.
The trial demonstrated that both 2mg and 1mg doses of baxdrostat delivered clinically meaningful reductions compared to placebo. At 12 weeks, the 2mg dose lowered mean seated systolic blood pressure by 15.7 mmHg from baseline, representing a placebo-adjusted reduction of 9.8 mmHg. The 1mg dose reduced pressure by 14.5 mmHg, a placebo-adjusted drop of 8.7 mmHg. In contrast, placebo produced a 5.8 mmHg reduction. These effects were consistent across patient subgroups.
Safety findings showed baxdrostat was generally well tolerated. Rates of hyperkalemia were low and comparable between treatment groups and placebo, and most adverse events were mild. The safety profile aligned with the drug’s mechanism of action.
Secondary endpoints reinforced the primary outcome. Both doses significantly lowered diastolic blood pressure and nearly tripled the likelihood of patients achieving a target systolic pressure below 130 mmHg. Longer-term benefits were also observed, with the 2mg dose demonstrating durable reductions over time. In exploratory analyses, baxdrostat improved 24-hour and nighttime blood pressure readings, which are considered key predictors of cardiovascular risk.
“Achieving a nearly 10 mmHg placebo-adjusted reduction in systolic blood pressure with baxdrostat is exciting, as this level of reduction is linked to substantially lower risk of heart attack, stroke, heart failure and kidney disease,” said Dr. Bryan Williams, chair of medicine at University College London and primary investigator.
Globally, an estimated 1.3 billion people live with hypertension, and nearly half of U.S. patients on multiple therapies still do not achieve adequate blood pressure control. Researchers highlighted aldosterone’s emerging role as a driver of resistant hypertension, pointing to baxdrostat’s mechanism as a potentially important advance.
Sharon Barr, executive vice president of biopharmaceuticals R&D, said the trial results support advancing regulatory submissions and expanding development programs to include related conditions such as chronic kidney disease and prevention of heart failure.
Baxdrostat is currently being studied in a global clinical program involving more than 20,000 participants, exploring its role as both monotherapy and in combination therapies across multiple cardiovascular and renal indications.
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