FDA Approval

FDA Approval Granted for Baxdrostat (Baxfendy) for Adults With Uncontrolled Hypertension

Edited by:
Anthony Calabro, MA

Key Highlights

  • Baxfendy (baxdrostat) was approved in the United States for adults with hypertension, in combination with other antihypertensive medications.
  • Approval was based on patients with uncontrolled or resistant hypertension who were taking 2 or more antihypertensive agents in the phase 3 BaxHTN trial.
  • At week 12, baxdrostat 2 mg reduced seated systolic blood pressure by 15.7 mm Hg from baseline and 9.8 mm Hg vs placebo.
  • The press release reported that baxdrostat was generally well-tolerated with no unanticipated safety findings.

On May 18, 2026, the FDA approved Baxdrostat (Baxfendy) for the treatment of hypertension, in combination with other antihypertensive medications, to lower blood pressure in adults whose hypertension is not adequately controlled. Baxdrostat is an oral small-molecule aldosterone synthase inhibitor that targets aldosterone synthase, an enzyme encoded by the CYP11B2 gene and involved in aldosterone synthesis in the adrenal gland.

The approval was based on results from the phase 3 BaxHTN trial, which included patients with uncontrolled and resistant hypertension receiving standard of care. During the 12-week double-blind, placebo-controlled portion of the trial, 796 patients were randomized 1:1:1 to receive baxdrostat 2 mg, baxdrostat 1 mg, or placebo once daily in addition to standard of care. The primary efficacy endpoint was the difference in mean change from baseline in seated systolic blood pressure at week 12 between each baxdrostat dose and placebo.

At week 12, the 2-mg dose reduced mean seated systolic blood pressure by 15.7 mm Hg from baseline and by 9.8 mm Hg vs placebo. The 1-mg dose reduced mean seated systolic blood pressure by 14.5 mm Hg from baseline and by 8.7 mm Hg vs placebo. The placebo group had a 5.8-mm Hg reduction from baseline. Results were reported as consistent across uncontrolled and treatment-resistant hypertension subgroups.

“Baxfendy demonstrated statistically significant and clinically meaningful seated systolic blood pressure reduction at both 2 mg and 1 mg doses in patients with uncontrolled and resistant hypertension on two or more medications,” the company stated in the release.

Baxdrostat was reported to be generally well tolerated, with no unanticipated safety findings.

The approved treatment is administered orally once daily. In the BaxHTN trial, baxdrostat was evaluated at 2 mg and 1 mg doses on top of standard of care.

Reference
AstraZeneca. Baxfendy approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension. Published May 18, 2026. Accessed May 20, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/Baxdrostat-MNR-2026.html