AstraZeneca has announced positive high-level results from its BaxHTN phase III trial showed baxdrostat at two doses (2mg and 1mg) demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure (SBP) compared with placebo at 12 weeks.
The trial also successfully met all secondary endpoints. Patients with uncontrolled or treatment resistant hypertension received baxdrostat or placebo on top of standard of care. Baxdrostat was generally well tolerated with a favourable safety profile.
There are 1.3bn people worldwide living with hypertension. When uncontrolled, hypertension can lead to a higher risk of heart attack, stroke, heart failure and kidney disease. In the US, approximately 50% of hypertensive patients who are on multiple treatments do not have their blood pressure under control. Growing evidence points to aldosterone dysregulation as one of the key biological drivers of hypertension.
Bryan Williams, chair of Medicine at University College London, primary investigator, said: “Many people continue to struggle with high blood pressure that is hard to control, even when taking multiple medications. The highly promising BaxHTN Phase III results show that once-daily baxdrostat on top of standard of care can meaningfully lower systolic blood pressure and offer a potential new treatment approach for controlling hypertension, the leading risk factor for cardiovascular disease.”
Sharon Barr, executive vice president, BioPharmaceuticals R&D, said: “We are very excited with the BaxHTN phase III results, which show statistically significant and clinically meaningful reductions in systolic blood pressure. These findings provide compelling evidence of baxdrostat’s potential to address a critical unmet need by targeting aldosterone dysregulation, bringing a novel mechanism to a field that has seen little innovation in over two decades.”
BaxHTN is a phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of baxdrostat in patients with uncontrolled hypertension being treated with two different antihypertensive medications and patients with resistant hypertension being treated with three or more different antihypertensive medications, one of which is a diuretic.
The data will be shared with regulatory authorities around the world and presented in a late‑breaking Hot Line session at the European Society of Cardiology (ESC) Congress in August 2025.
Baxdrostat is a potential first-in-class, highly selective aldosterone synthase inhibitor (ASI) that targets the hormone driving elevated blood pressure and increased cardiovascular and renal risk. It is currently being investigated in clinical trials as a monotherapy for hypertension and primary aldosteronism, and in combination with dapagliflozin for chronic kidney disease and the prevention of heart failure in high-risk hypertensive patients.
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