Novel Drug Baxdrostat Shows Promise in Lowering Blood Pressure and Protecting Kidneys
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A new medication, baxdrostat, designed to inhibit the production of the hormone aldosterone, has demonstrated significant potential in managing high blood pressure and slowing the progression of kidney disease, according to preliminary research unveiled at the American Heart Association’s Hypertension Scientific Sessions 2025 and simultaneously published in the Journal of the American Society of Nephrology. The Phase 2 clinical trial, known as FigHTN, suggests baxdrostat could offer a new therapeutic avenue for individuals with chronic kidney disease and uncontrolled hypertension.
The Link Between Kidney Disease and High Blood Pressure
Chronic kidney disease and high blood pressure frequently coexist, creating a dangerous cycle where one condition exacerbates the other. Unmanaged, this combination can lead to severe health consequences, including heart attack, stroke, heart failure, and ultimately, kidney failure. Aldosterone, a hormone produced by the adrenal glands, plays a key role in both conditions. It regulates sodium and water retention, directly impacting blood pressure. Over time, excess aldosterone can stiffen blood vessels, contributing to heart damage and kidney scarring.
FigHTN Trial Results: A Significant Reduction in Blood Pressure and Proteinuria
The FigHTN trial involved 192 participants with both chronic kidney disease and uncontrolled high blood pressure despite already being treated with either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB). Participants were randomized to receive either a low dose or high dose of baxdrostat, or a placebo, in addition to their existing medications.
After 26 weeks, the study revealed that baxdrostat led to an average reduction of 8.1 mm Hg in systolic blood pressure – approximately a 5% decrease – compared to the placebo group. Furthermore, researchers observed a substantial 55% reduction in albuminuria, the presence of albumin (a protein) in the urine, in those taking baxdrostat. Albuminuria is a critical marker of both kidney and cardiovascular risk.
“These findings are encouraging for people living with chronic kidney disease and high blood pressure, two conditions that often go hand-in-hand and create a dangerous cycle,” said lead study author Jamie P. Dwyer, M.D., a professor of medicine at University of Utah Health in Salt Lake City. “High blood pressure can worsen kidney function and declining kidney function can further elevate blood pressure, and these outcomes can be life-altering for patients.”
Safety and Side Effects
While baxdrostat demonstrated promising efficacy, the trial also monitored for potential side effects. High potassium levels in the blood, a known risk with medications affecting the renin-angiotensin-aldosterone system, were observed in 41% of participants on baxdrostat, compared to 5% on placebo. However, most cases were mild to moderate. Nine percent of participants taking baxdrostat experienced a serious adverse event, compared to 3% in the placebo group, though no deaths or unanticipated adverse events occurred during the trial.
Potential for Long-Term Benefits and Future Research
The reduction in albuminuria observed in the study offers hope that baxdrostat may delay kidney damage. Researchers are now investigating this potential further in two large Phase 3 trials.
“The reduction in urine albumin gives us hope that baxdrostat may also help delay kidney damage,” Dwyer explained. “This potential is now being tested in two large Phase 3 trials to determine if baxdrostat delays the progression of kidney disease.”
Jordana B. Cohen, M.D., M.S.C.E., immediate past chair of the American Heart Association’s Hypertension and Kidney Cardiovascular Science Committee, emphasized the significance of including patients with chronic kidney disease in this research. “Patients with chronic kidney disease were historically often excluded from drug studies,” she noted. “It is particularly reassuring to know that patients with chronic kidney disease…were represented in their own study, tolerated the medication well, and had both blood pressure and albuminuric benefits. This medication class could be a game changer in the management of hypertension in this patient group.”
Study Details and Participant Characteristics
The study included 195 individuals with an average age of 66. The participant pool comprised 32% women, 40% non-Hispanic white individuals, and 80% with Type 2 diabetes. The research was conducted across 71 sites in the United States. At the study’s outset, participants had an average systolic blood pressure of 151.2 mm Hg and an average eGFR of 44 mL/min/1.73, indicating existing kidney dysfunction.
Baxdrostat is currently not approved by the U.S. Food and Drug Administration and is being investigated for its potential to treat high blood pressure, chronic kidney disease, and heart failure. The study was funded by AstraZeneca, the developer of baxdrostat.
It is important to note that the findings presented are from a research abstract and have not yet undergone full peer review. However, the preliminary data suggest that baxdrostat represents a promising new approach to managing the complex interplay between high blood pressure and chronic kidney disease.
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