Long-Term Phase 3 BaxHTN Data Confirm Baxdrostat Efficacy and Safety in Resistant Hypertension
核心洞察
Baxdrostat 2 mg produced a mean seated systolic blood pressure reduction of -12.6 mmHg versus placebo/standard therapy, with the antihypertensive effect maintained through 52 weeks of treatment.
The 52-week safety profile remained consistent with the initial 12-week findings, with no additional clinically relevant safety signals emerging.
Baxdrostat, a highly selective aldosterone synthase (搜索) inhibitor, would represent the first therapeutic option based on aldosterone synthase inhibition for resistant hypertension (搜索), pending EMA approval.
Results from the Phase 3 BaxHTN study document the long-term efficacy and safety of baxdrostat in patients with uncontrolled or treatment-resistant arterial hypertension. The research, presented at the European Society of Cardiology (ESC) 2026 congress in Munich, evaluated the drug's long-term efficacy and safety in this patient population.
Baxdrostat at the 2 mg dose produced a mean reduction in seated systolic blood pressure of -12.6 mmHg compared with placebo/standard therapy, with the antihypertensive effect maintained up to 52 weeks of treatment. The safety profile up to 52 weeks was consistent with that observed in the first 12 weeks of treatment, with no emergence of additional clinically relevant safety signals.
Unmet Need in Resistant Hypertension
Arterial hypertension affects approximately one in three Italians and is among the most relevant modifiable risk factors for cardiovascular, cerebrovascular, and renal events. Despite guideline recommendations and the availability of standard pharmacological therapies, only 33% of patients in Italy reach the recommended therapeutic target.
"Hypertension is a chronic condition characterized by systematically elevated blood pressure levels, strongly impacting daily life and health status. Despite lifestyle changes and the use of standard therapies, a significant proportion of patients still does not reach ideal blood pressure levels, evidence of an important unmet clinical need," explained Massimo Volpe, President of SIPREC, Professor Emeritus at La Sapienza University and IRCCS San Raffaele in Rome.
Mechanism of Action
Baxdrostat is a highly selective inhibitor of aldosterone synthase (搜索), the enzyme responsible for aldosterone synthesis in the adrenal gland. Aldosterone is a hormone that contributes significantly to blood pressure elevation and to increased cardiovascular and renal risk. By acting upstream on hormone synthesis, baxdrostat intervenes at the level of the central pathophysiology of resistant hypertension (搜索), differentiating itself from mineralocorticoid receptor blockers, which act downstream by counteracting the already-produced effects of aldosterone.
This mechanism of action reflects the recognition of aldosterone as a principal determinant of organ damage in hypertension, with a central role in the development of heart failure, chronic kidney disease, and atherosclerotic disease.
Long-Term Efficacy and Safety Data
The 52-week data add to those from the 12-week BaxHTN study, published in the New England Journal of Medicine in 2025, which documented an absolute reduction in mean seated systolic blood pressure of -15.7 mmHg at the 2 mg dose and -14.5 mmHg at the 1 mg dose. The Phase 3 Bax24 study also documented a placebo-adjusted reduction of 14.0 mmHg in mean 24-hour systolic blood pressure in patients with treatment-resistant hypertension (搜索).
"Hypertension remains one of the areas characterized by the greatest unmet clinical need in the cardiovascular field. The lack of therapeutic innovation over the last twenty years has consolidated substantially unchanged therapeutic approaches over time. The 52-week results confirm long-term safety and efficacy, consolidating the role of aldosterone in the pathophysiology of uncontrolled and resistant hypertension (搜索)," stated Raffaela Fede, Medical Director of AstraZeneca Italia.
Regulatory Outlook
The approval of baxdrostat would introduce the first therapeutic option based on aldosterone synthase (搜索) inhibition for resistant hypertension (搜索). The next step for its dissemination is EMA approval, followed by the AIFA reimbursement pathway.