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Baxdrostat Cuts Blood Pressure in Phase 3 Trial as AstraZeneca Prepares Regulatory Filings

ESC‑presented NEJM data show a new aldosterone‑synthesis inhibitor delivered meaningful reductions with manageable electrolyte risks.

Overview

  • In the 12‑week BaxHTN trial, baxdrostat lowered seated systolic blood pressure by 8.7 to 9.8 mmHg versus placebo, with about 40% of patients reaching under 130 mmHg compared with 18.7% on placebo.
  • The multinational study enrolled roughly 796–800 adults with uncontrolled or resistant hypertension across 214 clinics, and an ambulatory substudy showed 24‑hour reductions of about 13.7–16.0 mmHg and lower night‑time averages.
  • Safety findings were dominated by electrolyte changes: hyperkalaemia (>6 mmol/L) occurred in 2.3% at 1 mg and 3.0% at 2 mg vs 0.4% with placebo, and mild hyponatraemia was more frequent on baxdrostat.
  • AstraZeneca says it will file for approval before year‑end 2025 and is aiming for potential U.S. and EU approvals in 2026, while projecting peak annual sales above $5 billion.
  • Investigators and commentators praised the mechanistic approach and potential for hard‑to‑control cases, as editorials called for longer‑term efficacy, safety and patient‑selection data.