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AstraZeneca Moves Closer to FDA Approval for Hard-to-Treat Hypertension Drug

MarketDash Editorial Team
5 days ago
The FDA has accepted AstraZeneca's application for baxdrostat, a drug targeting stubborn high blood pressure. Phase 3 trial data showed meaningful reductions in blood pressure for patients who haven't responded to standard treatments, with a decision expected in mid-2026.

AstraZeneca Plc (AZN) just cleared an important regulatory hurdle. On Tuesday, the FDA accepted the company's New Drug Application for baxdrostat, a medication designed to help adults whose high blood pressure refuses to cooperate despite taking multiple medications.

This matters because hypertension is surprisingly stubborn. About 1.4 billion people worldwide live with high blood pressure, and in the United States alone, roughly half of patients taking multiple blood pressure medications still can't get their numbers under control. That's a massive problem when you consider the cardiovascular and kidney risks that come with uncontrolled hypertension.

The Science Behind the Drug

Baxdrostat targets aldosterone, a hormone increasingly recognized as a major culprit in hard-to-control hypertension. When aldosterone levels run high, they contribute to elevated cardiovascular and kidney disease risk, making it a logical therapeutic target for patients who've exhausted standard options.

The FDA's acceptance is based on results from the BaxHTN Phase 3 trial, which were presented at the European Society of Cardiology Congress 2025 and published simultaneously in the New England Journal of Medicine. The trial tested baxdrostat as an add-on therapy for patients already taking either two antihypertensive agents (for uncontrolled hypertension) or more than three agents (for treatment-resistant hypertension), with at least one being a diuretic.

The Numbers Look Promising

At the 12-week mark, baxdrostat hit both its primary and secondary endpoints. The 2mg dose produced a 15.7 mmHg reduction in systolic blood pressure from baseline, with a 9.8 mmHg advantage over placebo. The 1mg dose showed a 14.5 mmHg reduction from baseline and an 8.7 mmHg edge over placebo.

For context, systolic blood pressure is the top number in your blood pressure reading. It measures the pressure in your arteries when your heart beats. Those reductions are clinically meaningful, particularly for a patient population that hasn't responded well to existing treatments.

The results held up consistently across both the uncontrolled and treatment-resistant patient subgroups, suggesting the drug works broadly within its target population. The safety profile looked reasonable too, with most adverse events classified as mild and no unexpected safety concerns emerging.

Timeline and What's Next

The FDA's decision is expected during the second quarter of 2026, following AstraZeneca's use of a Priority Review voucher. Beyond this application, the company is conducting an ambitious clinical development program for baxdrostat, with more than 20,000 patients enrolled in trials globally. Those studies are exploring the drug as a standalone treatment for hypertension and primary aldosteronism, as well as in combination with dapagliflozin for chronic kidney disease and heart failure prevention in high-risk patients.

AZN Price Action: AstraZeneca shares were up 0.96% at $91.04 at the time of publication on Wednesday.

Back to News

AstraZeneca Moves Closer to FDA Approval for Hard-to-Treat Hypertension Drug

MarketDash Editorial Team
5 days ago
The FDA has accepted AstraZeneca's application for baxdrostat, a drug targeting stubborn high blood pressure. Phase 3 trial data showed meaningful reductions in blood pressure for patients who haven't responded to standard treatments, with a decision expected in mid-2026.

AstraZeneca Plc (AZN) just cleared an important regulatory hurdle. On Tuesday, the FDA accepted the company's New Drug Application for baxdrostat, a medication designed to help adults whose high blood pressure refuses to cooperate despite taking multiple medications.

This matters because hypertension is surprisingly stubborn. About 1.4 billion people worldwide live with high blood pressure, and in the United States alone, roughly half of patients taking multiple blood pressure medications still can't get their numbers under control. That's a massive problem when you consider the cardiovascular and kidney risks that come with uncontrolled hypertension.

The Science Behind the Drug

Baxdrostat targets aldosterone, a hormone increasingly recognized as a major culprit in hard-to-control hypertension. When aldosterone levels run high, they contribute to elevated cardiovascular and kidney disease risk, making it a logical therapeutic target for patients who've exhausted standard options.

The FDA's acceptance is based on results from the BaxHTN Phase 3 trial, which were presented at the European Society of Cardiology Congress 2025 and published simultaneously in the New England Journal of Medicine. The trial tested baxdrostat as an add-on therapy for patients already taking either two antihypertensive agents (for uncontrolled hypertension) or more than three agents (for treatment-resistant hypertension), with at least one being a diuretic.

The Numbers Look Promising

At the 12-week mark, baxdrostat hit both its primary and secondary endpoints. The 2mg dose produced a 15.7 mmHg reduction in systolic blood pressure from baseline, with a 9.8 mmHg advantage over placebo. The 1mg dose showed a 14.5 mmHg reduction from baseline and an 8.7 mmHg edge over placebo.

For context, systolic blood pressure is the top number in your blood pressure reading. It measures the pressure in your arteries when your heart beats. Those reductions are clinically meaningful, particularly for a patient population that hasn't responded well to existing treatments.

The results held up consistently across both the uncontrolled and treatment-resistant patient subgroups, suggesting the drug works broadly within its target population. The safety profile looked reasonable too, with most adverse events classified as mild and no unexpected safety concerns emerging.

Timeline and What's Next

The FDA's decision is expected during the second quarter of 2026, following AstraZeneca's use of a Priority Review voucher. Beyond this application, the company is conducting an ambitious clinical development program for baxdrostat, with more than 20,000 patients enrolled in trials globally. Those studies are exploring the drug as a standalone treatment for hypertension and primary aldosteronism, as well as in combination with dapagliflozin for chronic kidney disease and heart failure prevention in high-risk patients.

AZN Price Action: AstraZeneca shares were up 0.96% at $91.04 at the time of publication on Wednesday.