CATEGORY: HEART & CIRCULATION
You can take two or three blood pressure medicines every day and still watch the monitor read high. For people stuck in that spot, a new pill called baxdrostat lowered systolic pressure, the top number, by nearly 10 points more than placebo over 12 weeks in a trial of 796 people.1 The FDA approved it in May 2026, making it the first blood pressure drug of its kind to reach pharmacies.
Stopping the Salt Hormone Where It’s Made
The target is aldosterone. It’s a hormone from the adrenal glands that tells your kidneys to hold on to salt and water, and in many people with stubborn hypertension there’s simply too much of it. Older drugs block the places where aldosterone lands. Baxdrostat instead shuts down the enzyme that manufactures it, cutting the hormone’s levels by roughly 60%. Think of silencing a message at the sender rather than plugging every mailbox it reaches. That upstream approach is what’s new here, and it’s why the drug class, aldosterone synthase inhibitors, had never been approved before.
Three Medicines Weren’t Enough for Most of These Patients
The trial recruited 796 adults at 214 clinics in 29 countries. All had readings of 140 or higher despite at least two medicines, and nearly three quarters qualified as treatment-resistant, meaning three or more drugs including a diuretic hadn’t controlled it. Chance sorted them into three groups: baxdrostat at 1 milligram, at 2 milligrams, or a matching placebo, each added on top of their usual pills. Nobody knew who had which. After 12 weeks, systolic pressure had fallen 15.7 points on the higher dose and 14.5 on the lower, against 5.8 on placebo.1 Later, some patients doing well on the drug were quietly switched back to placebo. Their pressure drifted up while those kept on treatment held steady, which shows the effect was the drug’s doing and lasted at least 32 weeks.
The Trade-off Is Potassium, and It Needs Watching
Blocking aldosterone makes the body retain potassium. Levels high enough to matter, above 6.0 in blood tests, occurred in 3% of people on the higher dose versus 0.4% on placebo, which is why treatment comes with blood-test monitoring in the first weeks. Results from an earlier, smaller trial of the same drug pointed the same way on pressure, so the finding didn’t arrive out of nowhere.2 The open question is the one 12 weeks can’t answer: whether the lower readings translate into fewer heart attacks and strokes over years. Blood pressure is a strong predictor, but it’s a marker, and the outcome trials are still ahead.
Key Takeaways
- In adults whose blood pressure stayed high on two or more drugs, adding baxdrostat lowered systolic pressure by about 9 to 10 points more than placebo at 12 weeks.
- The drug works upstream, blocking production of aldosterone, the salt-retaining hormone, rather than blocking its receptors. It’s now FDA-approved.
- Elevated potassium is the key side effect, affecting about 3% at the higher dose, so early blood-test checks come with the prescription.
- The trial measured blood pressure, not heart attacks or strokes. Whether the new class prevents those events over the long run hasn’t been shown yet.
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(14):1363–1374. link
- Freeman MW, Halvorsen YD, Marshall W, et al. Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension. The New England Journal of Medicine. 2023;388(5):395–405. link