AstraZeneca announces new phase III clinical data for baxdrostat

AstraZeneca announced new Phase III clinical data for baxdrostat, an investigational, first-in-class, oral aldosterone synthase inhibitor being studied for patients with uncontrolled or resistant hypertension. The results of the BaxHTN phase III study were presented at the European Society of Cardiology (ESC) Congress and published simultaneously in the New England Journal of Medicine (NEJM). Another phase III study Bax24 was also presented at the AHA (American Heart Association) Global Conference in November, reinforcing baxdrostat’s positioning as a next-generation aldosterone synthase inhibitor for hard-to-treat hypertension.

Hypertension is a leading contributor to cardiovascular morbidity and mortality in India, with estimates attributing approximately 1.6 million deaths annually to ischemic heart disease and stroke. Uncontrolled blood pressure is linked to nearly 57% of stroke deaths and 24% of coronary deaths in India, according to the National Health Mission, Ministry of Health and Family Welfare. Despite available therapies, treatment and control rates remain low—about 30% and 15%, respectively—leaving a substantial unmet clinical need.

Baxdrostat’s potential significance lies in its novel mechanism of directly inhibiting aldosterone production, offering a targeted approach for patients whose blood pressure remains above goal despite multiple antihypertensive agents. In the Phase III BaxHTN study, baxdrostat 2 mg achieved a placebo-adjusted reduction in seated systolic blood pressure of 9.8 mmHg at 12 weeks, meeting the primary endpoint. Reductions of this magnitude are commonly associated with clinically meaningful improvements in cardiovascular risk at the population level [3]. Secondary endpoints, including changes in diastolic blood pressure and the proportion of patients reaching target blood pressure, were also achieved.

Speaking on the importance of these clinical trial results, Dr Sandeep Arora, Director Medical Affairs, AstraZeneca India, said, “These results add to the growing body of evidence supporting aldosterone synthase inhibition as a promising approach for patients with hard-to-control hypertension. In a country like India, where many people live with uncontrolled blood pressure, an oral, targeted mechanism has the potential to help address a significant disease burden. Further evaluation is underway to better characterise which patients may benefit most from baxdrostat, inform early monitoring strategies, and assess long-term durability of blood pressure reduction and impact on cardiovascular outcomes.”

Further research will focus on identifying patients most likely to benefit from Baxdrostat for precision therapy, standardising early monitoring, and providing long-term data on durability and cardiovascular event reduction. These robust and promising results could be a crucial step toward making this innovative therapy available to patients in India and worldwide, a promising advancement against resistant hypertension.