AstraZeneca's Novel Oral Agent Baxdrostat Achieves Positive Phase 3 Results in Difficult-to-Control Hypertension

August 31, AstraZeneca（AstraZeneca）Announced that the positive full results of the BaxHTN Phase 3 trial showed, compared with placeboPatients with difficult-to-control (uncontrolled and refractory) hypertension experienced a statistically and clinically significant reduction in mean seated systolic blood pressure (SBP) after receiving two doses (2 mg and 1 mg) of baxdrostat for 12 weeks on top of standard antihypertensive therapy.The relevant data were announced on August 30 during the Hot Line session at the 2025 European Society of Cardiology (ESC) Annual Meeting and simultaneously published in The New England Journal of Medicine.

Baxdrostat Achieved Primary and All Secondary Endpoints in the BaxHTN Phase 3 Trial, Demonstrating Significant and Sustained Blood Pressure Reduction in Patients with Resistant Hypertension. At Week 12 of Treatment,The absolute reduction in mean seated systolic blood pressure from baseline in the Baxdrostat 2 mg dose group was 15.7 mmHg, with a placebo-adjusted reduction of 9.8 mmHg.The absolute reduction in mean seated systolic blood pressure in the 1 mg dose group was 14.5 mmHg, with a placebo-adjusted reduction of 8.7 mmHg. The mean seated systolic blood pressure in the placebo group decreased by 5.8 mmHg. These results were consistent in the uncontrolled and resistant hypertension subgroups.

Baxdrostat was generally well-tolerated, with no unexpected safety events observed. Compared with the placebo group (0.0%), the incidence of definitively diagnosed hyperkalemia (serum potassium >6 mmol/L) was lower in the two Baxdrostat dose groups (both at 1.1%). Its safety profile is consistent with the mechanism of action, and most adverse events were mild.

In this trial, Baxdrostat also met all confirmatory secondary endpoints. Notably, the 2 mg dose group of Baxdrostat demonstrated sustained long-term blood pressure reduction. Both the 2 mg and 1 mg dose groups achieved more significant diastolic blood pressure reductions, with nearly three times as many patients reaching the target systolic blood pressure of <130 mmHg compared to the placebo group.

In a pre-specified exploratory subgroup analysis, baxdrostat significantly reduced 24-hour and nighttime ambulatory systolic blood pressure compared to placebo, both of which are important indicators for sustained blood pressure control and reduction of cardiovascular risk. The 2 mg dose group reduced 24-hour systolic blood pressure by 16.9 mmHg (95% CI, –25.6 to –8.3), and the combined analysis of the 2 mg and 1 mg dose groups showed an 11.7 mmHg reduction in nighttime systolic blood pressure (95% CI, –19.5 to –3.8). Results from the Bax24 Phase 3 trial, which evaluates the effect on 24-hour ambulatory blood pressure control, are expected to be announced later this year.

"BaxHTN III Phase clinical trial results are exciting," said Dr. Bryan Williams, Head of the Department of Medicine at University College London and Chief Researcher.After placebo correction, baxdrostat achieved a nearly 10 mmHg reduction in systolic blood pressure, a decrease that is expected to significantly reduce the risk of heart attacks, strokes, heart failure, and kidney disease. These study data suggest that aldosterone plays a more important role in treatment-resistant hypertension than previously understood, highlighting the importance and potential impact of baxdrostat's innovative mechanism of action."Is expected to benefit millions of hypertensive patients whose blood pressure remains difficult to control despite having received various treatments."

Sharon Barr, Executive Vice President of AstraZeneca and Head of Global Biopharmaceuticals R&D, said: "The results of the BaxHTN Phase 3 trial demonstrate the potential of baxdrostat in addressing difficult-to-control hypertension despite multiple treatments, one of the toughest challenges in cardiovascular therapy."We look forward to advancing the registration and submission of baxdrostat in multiple countries in the coming months, and rapidly progressing clinical development programs in indications where aldosterone plays a crucial role, such as chronic kidney disease and heart failure prevention.。"

Increasing evidence suggests that aldosterone dysregulation is one of the key biological drivers of hypertension, which can lead to elevated cardiovascular and renal risks in patients.A large meta-analysis found that every 10 mmHg reduction in systolic blood pressure can decrease the risk of major cardiovascular adverse events by approximately 20%.Further highlighting the urgent need for innovative treatments targeting the causes of hypertension.

Baxdrostat isHighly selective, potent oral small molecule drug,It is a highly selective aldosterone synthase inhibitor (ASI), targeting one of the hormones that cause increased blood pressure and elevated cardiovascular and renal risks.Clinical studies show that baxdrostat significantly reduces aldosterone levels over a wide dose range without affecting cortisol levels.Currently, the drug is undergoing clinical trials worldwide, with more than 20,000 patients enrolled cumulatively. The trials include its use as a monotherapy for treating hypertension and primary aldosteronism, combination therapy with dapagliflozin for chronic kidney disease and hypertension, as well as the prevention of heart failure in patients with hypertension.

References:
[1] Baxdrostat Demonstrates Statistically and Clinically Significant Reduction in Systolic Blood Pressure in Patients with Resistant Hypertension in the BaxHTN Phase III Trial. From https://www.prnasia.com/story/501548-1.shtml

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