CATEGORY: HEART & CIRCULATION
A once-daily pill from a drug class that did not exist in pharmacies lowered systolic blood pressure about 9 to 10 points further than placebo, in adults whose readings stayed high on two, three or more medicines.1 The drug is baxdrostat. It also roughly doubled the share of participants who reached a healthy blood-pressure target, about 40% against 18.7% on placebo. It has since become the first medicine of its kind approved in the United States.
When Three Pills Are Not Enough
Blood pressure that will not come down on treatment is common and dangerous. Among the tens of millions of adults treated for hypertension, a meaningful fraction stay high on multiple drugs, carrying extra risk of heart attack, stroke and kidney damage. The trial, called BaxHTN, enrolled 796 of them. Average pressure at the start was 149/85 on a median of three blood-pressure medicines. About three quarters met the definition of resistant hypertension, meaning pressure that stays high despite three drugs including a diuretic.
Turning Down the Tap Instead of Bailing Water
Many stubborn cases trace back to aldosterone, a hormone from the adrenal glands that tells the kidneys to hold on to salt and water. Baxdrostat works upstream of every existing class. Rather than blocking what the hormone does, it quiets the enzyme that manufactures aldosterone in the first place. Less bailing, more closing the tap. Participants took baxdrostat at one of two doses or a placebo on top of their usual medicines, with the allocation randomized and hidden from patients and doctors alike.
Twelve Weeks Later, Twice as Many at Target
Seated systolic pressure had fallen 8.7 points more than placebo on the lower dose and 9.8 points more on the higher one. Reductions of that size, sustained over years, have been associated in blood-pressure research generally with meaningfully fewer strokes and heart attacks. About 40% of participants on either dose reached a systolic reading below 130, against 18.7% on placebo. An exploratory 24-hour monitoring analysis pointed the same way, including lower pressure overnight. Those are the hours when high readings are hardest on the heart.
The Ledger on a New Mechanism
Aldosterone helps the kidneys shed potassium, so quieting it can push potassium up. Markedly elevated potassium occurred in about 1% of baxdrostat participants, and roughly 1 to 1.5% stopped the drug over potassium changes. Serious adverse events overall were no more common than with placebo, and no adrenal insufficiency was reported. The investigators concluded that the reductions were clinically meaningful with no unanticipated safety findings. US regulators approved baxdrostat in May 2026, the first aldosterone synthase inhibitor for hypertension and the first genuinely new class of blood-pressure medicine in years.
Key Takeaways
- Among 796 adults whose blood pressure resisted their current medicines, baxdrostat lowered systolic pressure 8.7 to 9.8 points more than placebo over 12 weeks, on top of what they were already taking.
- About 40% of participants on baxdrostat reached a systolic reading below 130, roughly double the placebo rate of 18.7%.
- Elevated potassium was the safety finding to note, occurring in about 1% of participants. US regulators approved it in May 2026 as the first medicine in its class.
References
- Flack JM, Azizi M, Brown JM, et al. Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension. The New England Journal of Medicine. 2025;393:1363–1374. link