A novel drug may significantly improve outcomes for a subset of patients with high blood pressure, according to findings published in The New England Journal of Medicine.
Primary aldosteronism — a condition in which the adrenal glands produce too much aldosterone — is a common yet often underdiagnosed cause of endocrine hypertension. Excessive aldosterone can lead to salt and fluid retention, elevated blood pressure and other cardiovascular events.
“Primary aldosteronism is the most common cause of hypertension caused by an endocrine disorder,” said Wenyu Huang, MD, PhD, associate professor of Medicine in the Division of Endocrinology, Metabolism and Molecular Medicine, who was a co-author of the study. “Up to one out of seven patients with hypertension may have this condition.”
For decades, treatment options for primary aldosteronism have remained largely unchanged, with spironolactone being the only approved medication for this condition. However, spironolactone may not be fully effective for many patients due to underdosing and can cause undesirable side effects, Huang said.
“Men treated with spironolactone for this condition can develop gynecomastia and erectile dysfunction among other side effects. Until this study, we had no other potential options for treatment,” he said.
In the study, investigators treated 15 patients with primary aldosteronism with baxdrostat, a new drug designed to block the overproduction of aldosterone with high specificity.
After 12 weeks, investigators found that the average systolic blood pressure dropped by nearly 25 mm Hg, a reduction rarely seen in hypertension trials, and 73 percent of patients reached the target blood pressure of under 140/90 mm Hg. There was also a 97 percent median reduction in the aldosterone levels, surpassing even the effects of adrenal gland surgery.
While some patients experienced reversible kidney function decline during the extended 72-week follow-up, the drug’s benefits on blood pressure and hormone levels were sustained, according to the findings.
Although more research is needed to confirm the drug’s effects, the magnitude of the blood pressure and hormonal improvements suggests baxdrostat could represent a major advance in treating primary aldosteronism, Huang said.
“This is a paradigm shift in the treatment of primary aldosteronism,” Huang said. “Additionally, this is a condition that is oftentimes overlooked and underdiagnosed. Previously, diagnosing this condition has been relatively difficult for someone who’s not specialized in the field because there are so many steps involved in making the diagnosis. The new Endocrine Society guideline on primary aldosteronism, which was just published in July 2025, has make it easier for clinicians to screen, diagnose and treat this condition.”
Now, Huang and his collaborators are launching a Phase III clinical trial to test the drug’s effectiveness in a larger patient cohort with primary aldosteronism.
“With better diagnostic techniques and treatment options, I’m hopeful that more patients can be effectively diagnosed and treated for this condition in the future,” Huang said.
The study was funded by CinCor Pharma and AstraZeneca.