At the 2025 European Society of Cardiology meeting in Madrid, AstraZeneca reported positive high-level Phase III BaxHTN results for baxdrostat, a highly selective aldosterone synthase inhibitor. The drug produced statistically significant and clinically meaningful reductions in systolic blood pressure on top of standard therapy. The trial met the primary endpoint and all secondary endpoints. The overall profile was generally well tolerated, with signals of durable benefit that support rapid regulatory engagement.
Resistant hypertension (RH) is blood pressure that stays above target despite adherence to maximally tolerated doses of at least three different drug classes. These usually include a renin–angiotensin blocker, a calcium channel blocker, and a thiazide-like diuretic. Some patients only reach the target when a fourth drug is added. This population faces excess cardiovascular and renal risk due to persistent haemodynamic load and aldosterone-driven organ damage. Aldosterone dysregulation is central in many cases. Mineralocorticoid receptor antagonists help, but are often limited by hyperkalemia and endocrine side effects. A selective blocker of aldosterone synthesis can therefore fill a clear treatment gap.
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BaxHTN randomised adults with uncontrolled or resistant hypertension on background therapy to baxdrostat 2mg, 1mg, or placebo once daily for 12 weeks. Placebo-adjusted reductions in seated systolic blood pressure were 9.8mmHg with 2mg and 8.7mmHg with 1mg, versus a 5.8mmHg fall on placebo. Absolute reductions were 15.7mmHg and 14.5mmHg, respectively. All secondary endpoints were met, including categorical targets and 24h and nighttime ambulatory measures. Effects were consistent across age, sex, race, baseline blood pressure, kidney function, body mass index, and across uncontrolled and resistant cohorts. Responses were maintained for at least 32 weeks in follow-up.
Baxdrostat was generally well tolerated with mostly mild adverse events. Confirmed serum potassium above 6.0mmol per liter occurred in 1% of baxdrostat arms, and no adrenal insufficiency was reported, which is important for a selective aldosterone synthase inhibitor.
Key opinion leaders (KOLs) interviewed by GlobalData were positive but measured. Experts said that “baxdrostat is a promising therapy for resistant hypertension patients,” while stressing that “we need to see long-term data” on durability, electrolyte safety, and cardiovascular outcomes before changing treatment guidelines.
From a pharmaceutical strategy perspective, BaxHTN de‑risks the aldosterone synthase mechanism and supports accelerated filings in major markets. The data create competitive pressure on generic mineralocorticoid receptor antagonists and centrally acting add‑ons. Early adoption is most likely in patients limited by hyperkalemia, endocrine effects, or inadequate response to current options. Lifecycle opportunities exist in chronic kidney disease and heart failure prevention, which align with AstraZeneca’s cardiovascular, renal, and metabolic portfolio. Payer value will depend on cost‑effective positioning versus generics, advantages in ambulatory blood pressure, and real‑world persistence.
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By GlobalDataDespite some concerns for longer follow-up, BaxHTN establishes baxdrostat as a differentiated, once‑daily oral option that meaningfully reduces blood pressure in difficult‑to‑treat patients. The programme is well placed to reshape impact treatment approaches in resistant hypertension as guideline and payer discussions progress.
