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03 Dec 2025
Admin
News Article

AstraZeneca’s Baxdrostat Moves Into Priority Review: A New Hope for Hard-to-Control Hypertension

Hypertension affects 1.4 billion people worldwide. Yet half of the treated patients in the US still can’t control their blood pressure. Progress has been painfully slow for decades.
AstraZeneca is trying to change that.

Baxdrostat Gets Priority Review

The US FDA has accepted AstraZeneca’s New Drug Application for baxdrostat, a first-in-class aldosterone synthase inhibitor. The drug also received Priority Review, speeding up the regulatory timeline. A decision is expected in Q2 2026.

Why Baxdrostat Matters?

Aldosterone is now recognized as a major driver of hard-to-control hypertension. It pushes blood pressure higher by promoting sodium and water retention. Many patients stay uncontrolled even on multiple medications.

Baxdrostat directly targets this pathway with high selectivity, offering a new mechanism after two decades of limited innovation.

Strong Phase III Data

The NDA is based on results from the BaxHTN Phase III trial, presented at the ESC Congress 2025.

Key findings:

Met all primary and secondary endpoints
Significant SBP reductions at 12 weeks
2 mg dose: 15.7 mmHg reduction (placebo-adjusted: 9.8 mmHg)
1 mg dose: 14.5 mmHg reduction (placebo-adjusted: 8.7 mmHg)
Consistent results across uncontrolled and resistant patients
Generally well tolerated with no major safety concerns

The trial also included withdrawal and long-term safety phases, reinforcing durability and safety over 52 weeks.

Hard-to-Control Hypertension: The Unmet Need

Hard-to-control hypertension remains a massive public-health challenge. Despite lifestyle changes and multi-drug therapy, many patients still fail to reach target blood pressure. Elevated aldosterone, high salt intake, obesity, and genetics worsen outcomes.

Long-term uncontrolled hypertension drives severe complications like stroke, heart failure, and kidney disease.

Baxdrostat’s Mechanism

Baxdrostat inhibits aldosterone synthase, the enzyme controlling aldosterone production. It lowers aldosterone without affecting cortisol, which is a key differentiator. The therapy is now being tested across more than 20,000 patients globally.

It’s also being explored alongside dapagliflozin for chronic kidney disease and heart failure prevention.

AstraZeneca’s CVRM Strategy

Baxdrostat strengthens AstraZeneca’s growing portfolio across cardiovascular, renal, and metabolic diseases. The company aims to slow disease progression, protect organs, and move towards future regenerative solutions.

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