Baxdrostat Phase III Trial Delivers Breakthrough in Hard-to-Control Hypertension

Baxdrostat Phase III Trial Delivers Breakthrough in Hard-to-Control Hypertension

By, Admin 3 September 2025

Baxdrostat has achieved positive full results in the BaxHTN Phase III trial, showing a statistically significant and clinically meaningful reduction in systolic blood pressure (SBP) compared with placebo at 12 weeks. The findings were presented during a Hot Line session at the European Society of Cardiology (ESC) Congress 2025 and published in the New England Journal of Medicine.

Key Efficacy Results

  • 2mg dose: Mean SBP reduction of 15.7 mmHg, with a placebo-adjusted drop of 9.8 mmHg (p<0.001).
  • 1mg dose: Mean SBP reduction of 14.5 mmHg, with a placebo-adjusted drop of 8.7 mmHg (p<0.001).
  • Placebo group: Reduction of 5.8 mmHg.
  • Results consistent across both uncontrolled and treatment-resistant hypertension subgroups.
  • Both doses nearly tripled the odds of patients reaching SBP <130 mmHg.

Safety Profile

  • Generally well tolerated with no unexpected safety signals.
  • Confirmed hyperkalaemia: 1.1% in each baxdrostat group vs 0% placebo.
  • Most adverse events were mild.

Secondary & Exploratory Findings

  • Durable effect: Sustained reductions during the withdrawal phase, supporting long-term benefit.
  • Diastolic pressure: Both doses lowered DBP significantly.
  • Ambulatory BP: 2mg dose reduced 24-hour SBP by 16.9 mmHg; pooled doses cut night-time SBP by 11.7 mmHg.
  • Bax24 trial (24-hour ambulatory BP effects) to read out later this year.

Expert Insights

Dr. Bryan Williams, University College London:

“Achieving nearly a 10 mmHg placebo-adjusted reduction in SBP is exciting. This level of reduction is strongly linked to lower risks of heart attack, stroke, heart failure and kidney disease. These results highlight aldosterone’s central role in hypertension and the promise of baxdrostat’s novel mechanism.”

Sharon Barr, EVP BioPharmaceuticals R&D, AstraZeneca:

“The BaxHTN Phase III results show baxdrostat’s potential to address one of the toughest challenges in cardiovascular care. We are preparing regulatory filings and expanding trials into chronic kidney disease and heart failure prevention.”

The Bigger Picture in Hypertension

  • Global burden: 1.3 billion people live with hypertension.
  • U.S. challenge: ~50% of patients on multiple treatments still lack BP control.
  • Impact: A 10 mmHg SBP reduction can lower major adverse cardiovascular events by ~20%.
  • Aldosterone’s role: Elevated levels drive sodium retention, poor BP control, and increased renal/cardiovascular risks.

About Baxdrostat

  • Mechanism: First-in-class aldosterone synthase inhibitor (ASI), targeting the hormone that drives elevated BP.
  • Selectivity: Lowers aldosterone without affecting cortisol.
  • Development: Being studied in 20,000+ patients globally for:
    - Hypertension
    - Primary aldosteronism
    - Chronic kidney disease (with dapagliflozin)
    - Prevention of heart failure

AstraZeneca acquired baxdrostat via its CinCor Pharma purchase in 2023, with contingent milestone payments tied to regulatory filings.

AstraZeneca’s CVRM Strategy

Cardiovascular, Renal & Metabolism (CVRM) is a core growth driver for AstraZeneca. The company is advancing therapies that protect organs, slow disease progression, and address interconnected conditions across the heart, kidneys, liver, and pancreas.

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