India Pharma Outlook Team | Tuesday, 15 July 2025
AstraZeneca reported encouraging top-line results from the Phase III BaxHTN trial, demonstrating baxdrostat's statistically significant and clinically significant decrease in mean seated systolic blood pressure (SBP) in patients with uncontrolled or treatment-resistant hypertension. As once-daily 1mg and 2mg doses with standard-of-care, baxdrostat beat placebo at 12 weeks. The trial also achieved all secondary endpoints.
Baxdrostat was generally well tolerated with an acceptable safety profile, AstraZeneca stated. The positive results will be submitted to the world's regulatory bodies and at the August 2025 European Society of Cardiology (ESC) Congress.
Approximately 1.3 billion individuals globally suffer from hypertension. In the US alone, almost half of all patients receiving combination therapy still do not achieve blood pressure control. Dysregulation of aldosterone, a hormone associated with greater cardiovascular and renal risk, is being increasingly recognized as a central biological driving force for hypertension.
Dr. Bryan Williams, University College London Professor of Medicine and trial principal investigator, stated, "A lot of patients are still unable to control their blood pressure on multiple medications. The BaxHTN Phase III results indicate that baxdrostat can decrease systolic BP appreciably and provide a useful new alternative for patients."
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Sharon Barr, EVP BioPharmaceuticals R&D, AstraZeneca, stated, "These results demonstrate the potential of baxdrostat to address an unmet, urgent need by blocking aldosterone dysregulation with a new mechanism in the treatment of hypertension after two decades of restricted innovation."
Baxdrostat is an investigational first-in-class aldosterone synthase inhibitor under study as monotherapy and combination for the treatment of hypertension, primary aldosteronism, chronic kidney disease, and heart failure prevention.
