AstraZeneca’s Baxdrostat Demonstrates Strong 24-Hour Blood Pressure Reduction In Phase III Resistant Hypertension Trial

Positive topline results from the Bax24 Phase III trial revealed that baxdrostat achieved a statistically significant and clinically meaningful reduction in 24-hour ambulatory systolic blood pressure (SBP) in patients with treatment-resistant hypertension (rHTN). Over a 12-week period, patients receiving baxdrostat 2 mg on top of standard therapy demonstrated a placebo-adjusted 14.0 mmHg reduction in 24-hour average SBP (95% CI -17.2, -10.8; p<0.0001). The effect was consistent throughout the entire day, including early morning hours, when cardiovascular risk peaks. Baxdrostat was well tolerated, with a safety profile similar to that observed in prior BaxHTN trial findings.

Dr. Bryan Williams, Chair of Medicine at University College London, primary investigator, said: “The landmark results from Bax24 Phase III trial demonstrate that patients with the hardest-to-control hypertension treated with baxdrostat achieved a highly clinically meaningful 14 mmHg placebo-adjusted reduction in 24-hour systolic blood pressure, which could transform treatment practice. It's remarkable to see this magnitude of reduction coupled with the fact that just over 70% of baxdrostat patients achieved guideline targets, consistently over 24 hours.”

Baxdrostat also met key secondary endpoints, including a 13.9 mmHg reduction in night-time SBP and a 10.3 mmHg decrease in seated SBP versus placebo (both p<0.0001). Notably, 71% of patients receiving baxdrostat achieved 24-hour SBP below 130 mmHg, compared with only 17% in the placebo group (OR 15.2, 95% CI 6.6–35.2; p<0.0001). These results reinforce baxdrostat’s potential to provide continuous, 24-hour blood pressure control—critical in reducing cardiovascular risk in patients whose hypertension remains uncontrolled despite multiple medications.

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, said: “The Bax24 data demonstrate the significant impact that baxdrostat’s long half-life and highly selective inhibition of aldosterone synthase can have in improving 24-hour and overnight blood pressure for patients with resistant hypertension. Patients with elevated night-time blood pressure are especially vulnerable to cardiovascular events, including heart attack and stroke. Together with the results from BaxHTN, these findings demonstrate the potential of baxdrostat to redefine what is possible for the millions of patients whose hypertension remains uncontrolled despite current therapies.”

With 1.4 billion people worldwide living with hypertension, and nearly half of U.S. patients on treatment still not achieving control, the need for novel, targeted therapies remains urgent. Baxdrostat works by selectively inhibiting aldosterone, a hormone that drives high blood pressure and contributes to heart and kidney complications. Early clinical studies have shown that baxdrostat achieves its peak plasma concentration within 2–4 hours and has a half-life of 26–30 hours, supporting once-daily dosing. Ongoing investigations are exploring its role as a monotherapy for hypertension and primary aldosteronism, as well as in combination with dapagliflozin for chronic kidney disease and heart failure prevention.