Policy & Regulation
AstraZeneca's Baxdrostat meets all endpoints in pivotal Phase III hypertension trial
14 July 2025 -

Science-led biopharmaceutical company AstraZeneca PLC (LSE: AZN) (STO: AZN) (Nasdaq: AZN) reported on Monday that baxdrostat met its primary and all secondary endpoints in the Phase III BaxHTN trial, demonstrating statistically significant and clinically meaningful reductions in systolic blood pressure (SBP) among patients with uncontrolled or treatment-resistant hypertension.

The study evaluated once-daily doses of 1mg and 2mg baxdrostat over 12 weeks, with both doses achieving superior SBP reduction versus placebo. All secondary endpoints - including reductions in diastolic blood pressure, SBP control rates below 130 mmHg, and tolerability - were also met. Baxdrostat was well tolerated with a favourable safety profile.

Baxdrostat, a potential first-in-class aldosterone synthase inhibitor, is designed to target a key hormonal driver of elevated blood pressure. The therapy is also being investigated for primary aldosteronism, chronic kidney disease and heart failure prevention in combination with dapagliflozin.

The BaxHTN trial enrolled 796 patients with difficult-to-control hypertension, randomised to receive either 2mg, 1mg baxdrostat or placebo. A randomised withdrawal period and a 52-week safety follow-up were also included. Detailed data will be presented at the European Society of Cardiology Congress in August 2025.

AstraZeneca acquired baxdrostat through its February 2023 purchase of CinCor Pharma Inc, with a potential USD500m contingent payment linked to regulatory submissions.

This development reinforces AstraZeneca's Cardiovascular, Renal & Metabolism (CVRM) portfolio as a key driver of long-term growth. The company remains focused on disease-modifying therapies that address interlinked conditions and improve outcomes across global patient populations.

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