AstraZeneca’s Baxdrostat Shows Promising Phase III Results In Treatment-Resistant Hypertension With Sustained Efficacy

Positive results from the Bax24 Phase III clinical trial revealed that baxdrostat achieved a statistically significant and clinically meaningful reduction in ambulatory 24-hour average systolic blood pressure (SBP) compared with placebo after 12 weeks. The blood pressure-lowering effect remained consistent throughout the day, including early morning hours, when patients with hypertension face the greatest cardiovascular risks.

Dr. Bryan Williams, Chair of Medicine at University College London, primary investigator, said: “The Bax24 results show that a once-daily baxdrostat regimen can deliver highly clinically meaningful reductions in 24-hour systolic blood pressure, including in the morning when patients are at greater risk of heart attack and stroke. These results are groundbreaking and together with the BaxHTN results mean we have the potential to change our treatment approach for the many patients whose hypertension remains uncontrolled despite current therapies.”

In the trial, patients with treatment-resistant hypertension (rHTN) received baxdrostat 2mg or placebo alongside standard-of-care medications. The treatment demonstrated a favorable safety profile, consistent with prior findings from the BaxHTN study, with no unexpected adverse events reported. These results reinforce baxdrostat’s promise in addressing persistent hypertension that remains uncontrolled despite multiple therapies.

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, said: “This second Phase III trial of baxdrostat shows substantial improvement in blood pressure, which reflects its durable half-life of up to 30 hours and highly selective inhibition of aldosterone synthase. Too many patients today have hypertension that remains hard-to-control throughout the day and night, making them especially vulnerable to cardiac events. We are advancing our regulatory filings and rapidly progressing our robust clinical development programme for baxdrostat, as both a mono- and combination-therapy, across additional conditions where aldosterone plays a key role, including primary aldosteronism, chronic kidney disease and heart failure prevention.”

Hypertension affects more than 1.4 billion people worldwide, and in the United States, about half of all treated patients still fail to maintain healthy blood pressure levels. Sustained 24-hour SBP control is a critical determinant of cardiovascular risk—research shows that a 9.5 mmHg rise in SBP can increase overall mortality by 30%. By selectively inhibiting aldosterone, baxdrostat helps regulate blood pressure and protect against heart and kidney complications. It continues to be studied as a standalone and combination therapy for hypertension, primary aldosteronism, chronic kidney disease, and heart failure prevention.