On Saturday, AstraZeneca Plc (NASDAQ:AZN) released full results from the BaxHTN Phase 3 trial evaluating baxdrostat. The company released the topline data in July.
The study showed baxdrostat demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure (SBP) at two doses (2mg and 1mg) compared with placebo at 12 weeks.
Results were seen in patients with hard-to-control (uncontrolled and resistant) hypertension who received baxdrostat or placebo on top of standard of care.
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The data was presented at the European Society of Cardiology (ESC) Congress 2025 and also simultaneously published in the New England Journal of Medicine.
Baxdrostat met the primary and all secondary endpoints in the BaxHTN Phase 3 trial, delivering meaningful and sustained blood pressure reductions in patients with hard-to-control hypertension.
At week 12, the absolute reduction from baseline in mean seated SBP was 15.7 mmHg, and the placebo-adjusted reduction was 9.8 mmHg for the 2mg dose.
For the 1mg dose, the absolute reduction from baseline was 14.5 mmHg, and the placebo-adjusted reduction was 8.7 mmHg.
The reduction in mean seated SBP with placebo was 5.8 mmHg. Results were consistent across both uncontrolled and treatment-resistant subgroups.
Baxdrostat was generally well tolerated with no unanticipated safety findings, and low rates of confirmed hyperkalaemia (>6 mmol/L in both dose groups [1.1% each]) compared with placebo (0.0%).
The safety profile of baxdrostat was consistent with its mechanism of action, and most adverse events were mild.
The trial also met all confirmatory secondary endpoints with baxdrostat, including durable long-term blood pressure reduction with baxdrostat 2mg.
Both 2mg and 1mg doses also led to greater reductions in diastolic blood pressure and nearly tripled the odds of patients reaching their target SBP <130 mmHg compared with placebo.
In a prespecified exploratory analysis of a subgroup of patients, baxdrostat meaningfully reduced 24-hour and ambulatory nighttime SBP compared with placebo, key indicators of sustained blood pressure control and reduced cardiovascular risk.
The 2mg dose lowered 24-hour SBP by 16.9 mmHg, and the pooled 2mg and 1mg doses lowered nighttime SBP by 11.7 mmHg.
The Bax24 Phase 3 trial, evaluating 24-hour ambulatory effects, is expected to read out later this year.
Baxdrostat is a potential first-in-class, highly selective aldosterone synthase inhibitor (ASI) that targets one of the hormones driving elevated blood pressure and increased cardiovascular and renal risk.
It is currently being investigated in clinical trials enrolling more than 20,000 patients globally, as a monotherapy for hypertension and primary aldosteronism, and in combination with dapagliflozin for chronic kidney disease and hypertension, and the prevention of heart failure in patients with hypertension.
Price Action: AZN stock is trading higher by 0.45% to $80.26 at last check Tuesday.
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