On May 18, AstraZeneca announced that its baxdrostat (trade name: Baxfendy) has been approved in the United States as the first aldosterone synthase inhibitor (ASI) to be used in combination with other antihypertensive drugs to treat hypertension and lower blood pressure in adults with poorly controlled blood pressure.
The product was submitted for market approval in China in February of this year.
Source: AstraZeneca official website
Baxdrostat is a first-in-class, highly selective aldosterone synthase inhibitor that lowers blood pressure by inhibiting aldosterone production.
In February 2023, AstraZeneca acquired CinCor for $1.8 billion, gaining access to Baxdrostat . In December 2025, AstraZeneca submitted a marketing application for the product to the FDA and was granted priority review status, allowing it to be used as adjunctive therapy to other antihypertensive drugs in cases where these drugs fail to adequately lower blood pressure, for the treatment of adult patients with refractory hypertension (uncontrolled or treatment-resistant).
This approval is based on data from the Phase III BaxHTN trial . BaxHTN was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III study designed to evaluate the safety, tolerability, and efficacy of Baxdrostat in patients with hypertension who had poor blood pressure control despite treatment with two different antihypertensive drugs, and in patients with hypertension who had poor blood pressure control despite treatment with three or more antihypertensive drugs (including one diuretic).
This study will be presented at the 2025 European Society of Cardiology (ESC) Congress in the session on Breakthrough Research. Results showed that Baxdrostat met all primary and secondary endpoints in the BaxHTN trial, achieving significant and durable blood pressure reduction in patients with refractory hypertension.
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At week 12 of treatment, the mean absolute reduction in sitting systolic blood pressure from baseline was 15.7 mmHg in the Baxdrostat 2 mg dose group, and 9.8 mmHg after placebo correction.
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The mean absolute decrease in sitting systolic blood pressure in the 1 mg dose group was 14.5 mmHg, which was 8.7 mmHg after placebo adjustment. The mean decrease in sitting systolic blood pressure in the placebo group was 5.8 mmHg.
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The above results were consistent in the uncontrolled and refractory hypertension subgroups.
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Baxdrostat was generally well tolerated, with no unexpected safety events observed. The incidence of definitively diagnosed hyperkalemia was lower in both Baxdrostat dose groups compared to the placebo group (0.0%). Its safety profile is consistent with its mechanism of action, with most adverse events being mild.
Source: Insight Database
Furthermore, Baxdrostat met all confirmatory secondary endpoints. The 2 mg dose group demonstrated a durable long-term blood pressure-lowering effect. Both the 2 mg and 1 mg dose groups achieved more significant reductions in diastolic blood pressure, and the rate of patients achieving systolic blood pressure <130 mmHg was nearly three times higher than in the placebo group.
In addition to hypertension, AstraZeneca is also conducting clinical trials of Baxdrostat for indications such as chronic kidney disease and heart failure .

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