AstraZeneca Seeks Approval for Antihypertensive Treatment This Year

AstraZeneca plans to submit regulatory filings for its blood pressure treatment baxdrostat by the end of this year, with potential approval expected in 2026. The small molecule therapy is a key part of the company's cardiovascular strategy, aiming to expand its presence in the hypertension market. AstraZeneca's senior executive believes the treatment has the potential to be a significant contributor to the company's future growth.

AstraZeneca is poised to submit regulatory filings for its novel blood pressure treatment, baxdrostat, by the end of 2025, with potential approval expected in 2026. This small molecule therapy is a key component of the company's cardiovascular strategy, aiming to expand its presence in the hypertension market.

Baxdrostat, a potential first-in-class, highly selective aldosterone synthase inhibitor (ASI), has shown promising results in clinical trials. The BaxHTN Phase III trial, published in the New England Journal of Medicine and presented at the European Society of Cardiology Congress 2025, demonstrated that baxdrostat significantly reduced systolic blood pressure (SBP) in patients with hard-to-control hypertension. The 2mg dose lowered SBP by 15.7 mmHg (9.8 mmHg placebo-adjusted) from baseline, while the 1mg dose reduced it by 14.5 mmHg (8.7 mmHg placebo-adjusted). These reductions were statistically significant and clinically meaningful, indicating a substantial improvement in blood pressure control [1].

The trial also showed that baxdrostat was generally well-tolerated, with no unanticipated safety findings. The low rates of confirmed hyperkalaemia (1.1% each for the 2mg and 1mg doses, compared to 0.0% for placebo) were consistent with its mechanism of action [1].

AstraZeneca's senior executive believes that baxdrostat has the potential to be a significant contributor to the company's future growth. The treatment targets aldosterone, a hormone that plays a key role in hard-to-control hypertension. Lowering aldosterone levels can lead to reduced cardiovascular and renal risk, making baxdrostat an attractive option for patients who are not adequately controlled by existing treatments [1].

The BaxHTN Phase III trial supports the primary and all secondary endpoints, including the demonstration of durable long-term blood pressure reduction with baxdrostat 2mg. Both 2mg and 1mg doses led to greater reductions in diastolic blood pressure and nearly tripled the odds of patients reaching their target SBP 130 mmHg compared to placebo [1].

AstraZeneca is currently investigating baxdrostat in various indications, including chronic kidney disease, heart failure prevention, and primary aldosteronism. The company acquired baxdrostat through its purchase of CinCor Pharma, Inc. in February 2023, and a contingent value right of $10 per share in cash ($0.5 billion) is payable to former CinCor shareholders upon the submission of a new drug application either in the US or Europe [19].

AstraZeneca's ambition is to improve and save the lives of millions of people by better understanding the interconnections between cardiovascular, renal, and metabolic diseases. The company's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide [19].

References:
[1] https://www.astrazeneca.com/media-centre/press-releases/2025/baxdrostat-demonstrated-statistically-significant-clinically-meaningful-reduction-sbp-patients-hard-control-hypertension-baxhtn-phase-iii-trial.html
[19] AstraZeneca's website