India Pharma Outlook Team | Wednesday, 03 December 2025
AstraZeneca's baxdrostat has taken a major step forward today as the US FDA accepted its New Drug Application (NDA) for Priority Review.
The drug is aimed at adults with hard-to-control hypertension who need added help even after multiple blood pressure treatments. The FDA decision sets a PDUFA date for the second quarter of 2026, supported by a Priority Review voucher.
Hypertension continues to affect 1.4 billion people worldwide, and in the US, nearly half of patients on several medications still fail to control their blood pressure. Aldosterone, a key hormone that drives this condition, plays a central role in poor outcomes. That is where baxdrostat stands out.
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Sharon Barr, executive vice president, biopharmaceuticals R&D, said: "This Priority Review demonstrates our commitment to advancing baxdrostat as a potential first- and best-in-class aldosterone synthase inhibitor for the millions of people living with hard-to-control hypertension as quickly as possible."
“The substantial reduction in systolic blood pressure seen in the BaxHTN trial underscores baxdrostat’s novel mechanism of action and its potential to bring innovation to a disease area that has seen limited progress in over two decades,” she added.
The NDA rests on results from the phase III BaxHTN trial, presented at ESC Congress 2025 and published in the New England Journal of Medicine. The study showed significant reductions in systolic blood pressure at week 12, with both 1mg and 2mg doses outperforming placebo. Benefits were consistent across uncontrolled and treatment-resistant groups. The drug was generally well tolerated, with mostly mild adverse events.
Designed as a selective aldosterone synthase inhibitor, the treatment targets aldosterone production without affecting cortisol. AstraZeneca continues to evaluate the therapy across global trials in hypertension, primary aldosteronism and chronic kidney disease.
