By Morgan Nwanguma
A new medication called baxdrostat may offer fresh hope for people whose blood pressure remains high despite taking standard treatments. Experts say hard-to-treat high blood pressure in Nigeria is caused by health system challenges like poor primary care integration and high medication costs, and patient-level issues such as low health literacy, poverty, and difficulty with long-term adherence. These factors lead to low awareness, treatment, and control rates, making management difficult. PharmaTimes Editor, MORGAN NWANGUMA writes that while efforts are underway to address these barriers through programmes modelled on the WHO’s HEARTS technical package, which aims to provide streamlined, affordable, and sustainable care at the primary health level, a new drug that blocks the production of aldosterone is presenting new hopes for people with hard-to-treat high blood pressure.
A novel drug known as baxdrostat is likely to bring fresh hope for individuals whose blood pressure remains high in spite of taking regular treatments. In a recent study, the drug not only lowered blood pressure but also appeared to protect the kidneys by reducing signs of damage, a promising development for millions living with chronic kidney disease (CKD), a condition that often makes blood pressure more difficult to control.
Research Highlights:
· Findings from the FigHTN Phase 2 clinical trial showed that baxdrostat, a novel drug that blocks the production of aldosterone, a hormone that raises blood pressure, reduced systolic blood pressure by about 5% when added to existing medications in patients with CKD and uncontrolled hypertension.
· The study also found that baxdrostat lowered urinary albumin loss by 55% compared with placebo. Since albumin loss is a key marker of kidney and cardiovascular risk, this suggests that baxdrostat may help slow the progression of kidney disease.
· Overall, these results indicate that baxdrostat could potentially improve long-term kidney and cardiovascular outcomes, while also reducing the need for intensive or costly treatments among people with uncontrolled high blood pressure and CKD.
According to preliminary findings presented at the American Heart Association’s Hypertension Scientific Sessions 2025, and published simultaneously in the Journal of the American Society of Nephrology, adding baxdrostat to standard care may represent a new strategy for managing high blood pressure and delaying kidney disease progression in patients with CKD.
Chronic kidney disease and hypertension are closely interconnected, and poor control of either can lead to severe complications such as heart attack, stroke, heart failure, and kidney failure. The hormone aldosterone, produced by the adrenal glands, contributes to these conditions by promoting sodium and water retention, which increases blood pressure. Over time, excessive aldosterone can cause blood vessel stiffening, heart damage, and kidney scarring, underscoring its key role in both hypertension and CKD.
“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 in the division of nephrology and hypertension 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.”
The study aimed to determine whether adding baxdrostat to standard treatment is both safe and effective in lowering blood pressure among people with chronic kidney disease (CKD) — severe enough to increase the likelihood of kidney failure or the need for a transplant — and uncontrolled hypertension. These participants had persistently high blood pressure despite already taking either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB), both of which target hormonal pathways that regulate blood pressure.
At the start of the trial, participants had an average systolic blood pressure of 151 mm Hg, even while on medication, and laboratory results confirmed kidney impairment. Their average urinary albumin level was 714 mg/g of creatinine (levels above 30 mg/g suggest CKD). The average estimated glomerular filtration rate (eGFR) — a key measure of kidney function — was 44 mL/min/1.73 m², well below the healthy threshold of 60.
Of the 195 individuals enrolled, 192 were randomly assigned to receive either a low dose (0.5–1 mg) or high dose (2–4 mg) of baxdrostat, or a placebo, alongside standard care. Three participants discontinued early due to side effects, personal choice, or other factors.
After 26 weeks:
· Participants taking baxdrostat experienced an average reduction in systolic blood pressure of 8.1 mm Hg more than those on placebo — approximately a 5% decrease.
· High potassium levels (a known risk when blocking the renin-angiotensin-aldosterone system) occurred in 41% of participants receiving baxdrostat versus 5% in the placebo group. Most cases were mild to moderate.
· No deaths or unexpected safety issues occurred, though 9% of participants taking baxdrostat and 3% of those on placebo experienced a serious adverse event.
In an exploratory analysis, researchers also examined urinary albumin excretion, a marker that predicts cardiovascular and kidney risk. They found that participants taking baxdrostat had 55% lower albumin levels than those receiving placebo — a reduction similar to what is seen with established treatments known to slow kidney disease progression.
“The reduction in urine albumin gives us hope that baxdrostat may also help delay kidney damage. This potential is now being tested in two large Phase 3 trials to determine if baxdrostat delays the progression of kidney disease,” said Dwyer.
“These new findings are reassuring that this new class of antihypertensive medications are likely to have both kidney-and-cardio-protective benefits and to be safe and effective for broad patient populations,” said Jordana B. Cohen, M.D., M.S.C.E., immediate past chair of the American Heart Association’s Hypertension and Kidney Cardiovascular Science Committee. “Patients with chronic kidney disease were historically often excluded from drug studies. It is particularly reassuring to know that patients with chronic kidney disease, who have very high rates of hypertension and elevated renin-angiotensin aldosterone activity, 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.” Cohen did not participate in this research – he is deputy director and associate professor of medicine and epidemiology in the Perelman School of Medicine at the University of Pennsylvania.
Study Details, Background, and Design:
· The study involved 195 participants with an average age of 66 years. Of these, 32% were women, 40% were non-Hispanic white, and 80% had Type 2 diabetes. The trial was conducted across 71 sites in the United States, and three participants were not randomized or included in the final analysis.
· All participants had uncontrolled high blood pressure — defined as systolic blood pressure of 140 mm Hg or higher, or 130 mm Hg or higher for individuals with Type 2 diabetes — despite taking the maximum tolerated dose of either an ACE inhibitor or an ARB as part of their treatment. The average systolic blood pressure at baseline was 151.2 mm Hg.
· Every participant also had chronic kidney disease (CKD), though none were in kidney failure. At baseline, the average estimated glomerular filtration rate (eGFR) was 44 mL/min/1.73 m² (within a range of 25–75), and the average urine albumin-to-creatinine ratio was 713.8 mg/g (levels ≥100 mg/g qualify for inclusion).
· A total of 192 participants were randomly assigned to one of three treatment groups:
o Low-dose baxdrostat: 0.5 mg/day, increased to 1 mg/day after two weeks
o High-dose baxdrostat: 2 mg/day, increased to 4 mg/day after two weeks
o Placebo
· After 26 weeks, participants underwent repeat blood pressure and kidney function testing. The primary analysis assessed changes in systolic blood pressure between the three groups, while adverse events were also monitored and recorded.
· Baxdrostat belongs to a new class of drugs that block aldosterone production, and it is currently being evaluated for potential use in treating high blood pressure, chronic kidney disease, and heart failure. The medication is not yet approved by the U.S. Food and Drug Administration (FDA).
Additional Information:
Co-authors’ disclosures and funding sources are available in the published abstract. The study was funded by AstraZeneca, the developer of baxdrostat.
The authors also note that the research was presented as an abstract at the American Heart Association’s Hypertension Scientific Sessions 2025.
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