FDA accepted AstraZeneca’s New Drug Application for baxdrostat under the Priority Review program on December 2, 2025, a designation that signals the agency views the drug as a significant improvement for patients with resistant or uncontrolled hypertension.
Baxdrostat is a selective aldosterone synthase inhibitor that reduces aldosterone production, targeting a root cause of hypertension that many patients fail to control with existing therapies. The Phase III BaxHTN trial demonstrated a clinically meaningful reduction in systolic blood pressure, with the 2 mg dose lowering seated SBP by 9.8 mmHg and the 1 mg dose by 8.7 mmHg after 12 weeks, and a favorable safety profile.
The priority review is expected to shorten the FDA review timeline to about six months, potentially bringing the drug to market in the second quarter of 2026. Analysts project peak annual sales of $4–5 billion, reflecting the large unmet need among the estimated 1.4 billion people with hypertension worldwide and the 10–20% of patients with resistant hypertension.
AstraZeneca acquired the drug through its 2023 purchase of CinCor Pharma for $1.3 billion, integrating baxdrostat into its cardiorenal portfolio. The company is also exploring combination therapy with Farxiga for chronic kidney disease and heart failure, positioning baxdrostat within its broader therapeutic strategy.
Executive Vice President Sharon Barr highlighted the priority review as evidence of the company’s commitment to advancing a first‑and‑best‑in‑class aldosterone synthase inhibitor, noting that the trial’s reduction in systolic blood pressure underscores the drug’s novel mechanism and potential to fill a long‑standing gap in hypertension treatment.
The regulatory milestone strengthens AstraZeneca’s competitive stance against other ASI candidates, such as Mineralys Therapeutics’ lorundrostat, and enhances the company’s market share in the high‑growth cardiorenal segment.
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