FDA approves Baxfendy (baxdrostat) as the first and only aldosterone synthase inhibitor treatment for adults with hypertension – AstraZeneca

AstraZeneca’s Baxfendy (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled.

There are 1.4 billion people worldwide living with hypertension. In the US, approximately 50% of patients living with hypertension who are already taking multiple antihypertensive medications still struggle with persistently elevated blood pressure, which is a leading risk factor for cardiovascular disease and premature death. Hypertension is the most prevalent and significant modifiable cardiovascular risk factor worldwide, accounting for more deaths and disability than any other modifiable risk.

Baxfendy is a first-in-class, highly selective and potent ASI designed to lower blood pressure in a new way by specifically inhibiting the production of aldosterone, a hormone that raises blood pressure to unhealthy levels and increases the risk of heart and kidney problems.

The approval by the FDA was based on positive results from the BaxHTN Phase III trial, with Baxfendy demonstrating statistically significant and clinically meaningful seated systolic blood pressure reduction at both 2mg and 1mg doses in patients with uncontrolled and resistant hypertension on two or more medications. Baxfendy was generally well-tolerated with no unanticipated safety findings.

Dr. Bryan Williams, Chair of Medicine at University College London, and BaxHTN primary investigator, said: “We have been waiting for an innovative medication like Baxfendy for hypertension for many years. Its novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension. In addition, the nearly double-digit placebo-adjusted systolic blood pressure reduction achieved with Baxfendy is exciting and clinically meaningful for clinicians and patients. Epidemiological data indicate that a 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events.”

John M. Clymer, Executive Director, National Forum for Heart Disease & Stroke Prevention, said: “Hypertension remains a staggeringly widespread silent killer and a leading risk factor for stroke, heart attack, kidney damage and dementia. Tens of millions of people struggle to control their blood pressure despite lifestyle changes and currently available treatments. Innovative, new treatments could help millions protect their heart, kidney and brain health.”

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The approval of Baxfendy offers a much‑needed, first-in-class innovation for people living with persistently uncontrolled hypertension who have not responded to or tolerated existing medicines. In the US, about 23 million patients are uncontrolled despite being on two or more medicines for hypertension, which is a disease that has seen little therapeutic progress for the past two decades.”

In the BaxHTN Phase III trial, published in the New England Journal of Medicine, Baxfendy (baxdrostat) demonstrated statistically significant and clinically meaningful efficacy for the treatment of patients with hypertension on top of standard of care. At week 12, the absolute reduction from baseline in mean seated SBP was 15.7 mmHg (95% confidence interval [CI], -17.6 to -13.7) and placebo-adjusted reduction was 9.8 mmHg (95% CI, -12.6 to -7.0; p<0.001) for the 2mg dose. For the 1mg dose, the absolute reduction from baseline was 14.5 mmHg (95% CI, -16.5 to -12.5) and placebo-adjusted reduction was 8.7 mmHg (95% CI, -11.5 to -5.8; p<0.001). The reduction in mean seated SBP with placebo was 5.8 mmHg (95% CI, -7.9 to -3.8). Results were consistent across both uncontrolled and treatment-resistant subgroups.

BaxHTN trial
The BaxHTN Phase III trial had three components to it that supported the following endpoints. The primary endpoint was assessed during a 12-week double-blind, placebo-controlled period. A total of 796 patients were characterised in a 1:1:1 ratio to receive Baxfendy 2mg, 1mg or placebo once daily on top of standard of care [2 antihypertensive agents at baseline, one of which is a diuretic for uncontrolled hypertension and ≥ 3 antihypertensive agents at baseline, one of which is a diuretic for resistant hypertension].The primary efficacy endpoint was the difference in mean change from baseline in seated SBP at week 12 between participants treated with baxdrostat (2mg or 1mg separately) and participants treated with placebo. Persistence of efficacy was assessed during a randomised withdrawal period from week 24 to week 32. Approximately 300 patients treated with Baxfendy 2mg were re-randomised in a 2:1 ratio to either continue receiving baxdrostat 2mg or placebo for the 8 weeks. SBP at the end of the 8 weeks was compared with placebo and the Baxfendy 2mg dose. Long-term safety was assessed at the end of the 52 weeks compared to a standard of care arm. Additional confirmatory secondary endpoints include the effect of Baxfendy versus placebo on seated SBP at week 12 in the resistant hypertension subpopulation, the effect of Baxfendy versus placebo on seated diastolic blood pressure at week 12, and proportion of participants achieving seated SBP less than 130 mmHg at week 12.

Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension. Authors: John M. Flack, M.D., Michel Azizi, M.D., Jenifer M. Brown, M.D. et al. Published August 30, 2025DOI: 10.1056/NEJMoa2507109