WILMINGTON, Del.– Full results from the BaxHTN Phase III trial showed baxdrostat achieved a statistically significant and clinically meaningful reduction in systolic blood pressure in patients with hard-to-control hypertension. The findings were presented today at the European Society of Cardiology (ESC) Congress 2025 and published simultaneously in the New England Journal of Medicine.
At 12 weeks, baxdrostat 2 mg lowered mean seated systolic blood pressure by 15.7 mmHg (9.8 mmHg placebo-adjusted; p<0.001) from baseline. The 1 mg dose lowered systolic pressure by 14.5 mmHg (8.7 mmHg placebo-adjusted; p<0.001). The placebo group showed a reduction of 5.8 mmHg. Results were consistent across both uncontrolled and resistant hypertension subgroups.
Baxdrostat met the primary and all secondary endpoints, including durable long-term reductions in blood pressure. Both 2 mg and 1 mg doses led to greater reductions in diastolic blood pressure and nearly tripled the odds of patients reaching a target systolic pressure below 130 mmHg compared with placebo. In exploratory analyses, baxdrostat also reduced 24-hour and nighttime systolic blood pressure, with the 2 mg dose lowering 24-hour pressure by 16.9 mmHg and pooled dosing lowering nighttime pressure by 11.7 mmHg.
The therapy was generally well tolerated, with low rates of confirmed hyperkalemia (1.1 percent in both active groups vs. 0.0 percent placebo) and no unexpected safety issues. Most adverse events were mild, and the safety profile aligned with its mechanism of action.
“Achieving a nearly 10 mmHg placebo-adjusted reduction in systolic blood pressure with baxdrostat in the BaxHTN Phase III trial is exciting, as this level of reduction is linked to substantially lower risk of heart attack, stroke, heart failure and kidney disease,” said Bryan Williams, M.D., Chair of Medicine at University College London and primary investigator. “These data show that aldosterone plays a greater role in hard-to-control hypertension than previously recognized, underscoring the importance of baxdrostat’s novel mechanism of action, and potential impact for the millions of people living with hard-to-control hypertension despite being on multiple treatments.”
“The BaxHTN Phase III results demonstrate baxdrostat’s potential in tackling one of the toughest challenges in cardiovascular care, which is hypertension that is hard to control despite multiple therapies,” said Sharon Barr, Executive Vice President, BioPharmaceuticals R&D. “We look forward to advancing our regulatory filings for baxdrostat with health authorities in the months ahead, in addition to rapidly progressing a robust clinical development program across indications where aldosterone plays a key role, including chronic kidney disease and heart failure prevention.”
Globally, an estimated 1.3 billion people live with hypertension. In the United States, about half of patients treated with multiple therapies still do not have their blood pressure under control. Dysregulation of aldosterone is increasingly recognized as a key driver of the disease, contributing to cardiovascular and renal complications. Research has shown that reducing systolic pressure by 10 mmHg can cut the risk of major adverse cardiovascular events by roughly 20 percent.
Baxdrostat is a potential first-in-class, highly selective aldosterone synthase inhibitor that targets a hormone central to blood pressure regulation and cardiovascular and renal risk. It is being studied in trials enrolling more than 20,000 patients worldwide, both as monotherapy and in combination regimens.
