Baxfendy, the first aldosterone synthase inhibitor to be approved by the FDA for high blood pressure, is among the products AstraZeneca is relying on to hit its 2030 goal of $80 billion in revenue.
The FDA has signed off on AstraZeneca’s baxdrostat to lower blood pressure in patients with uncontrolled hypertension. The drug, which will carry the brand name Baxfendy, is the first in its class in this indication.
Specifically, Baxfendy is the first aldosterone synthase inhibitor approved by the FDA for the treatment of hypertension, according to AstraZeneca’s news release on Monday. The drug is meant to be used in combination with other antihypertensives and is indicated for patients with uncontrolled or treatment-resistant hypertension.
With the approval, Baxfendy will enter a U.S. market of around 23 million treatable patients, Ruud Dobber, executive vice president of AstraZeneca’s BioPharmaceuticals Business Unit, said in a statement on Monday. Worldwide, some 1.4 billion people have hypertension, according to the pharma.
AstraZeneca is also continuing to develop Baxfendy in other cardiovascular conditions, including primary aldosteronism, chronic kidney disease and the prevention of heart failure, all of which are in late-stage development.
The pharma has named Baxfendy as one of the key product launches intended to help meet a goal of $80 billion in revenue by 2030, pegging the product’s peak sales at above $5 billion. Leerink Partners had an even more optimistic outlook for the drug, setting a revenue “potential of up to $10bn if successful in additional indications.”
Monday’s approval was backed by data from the Phase 3 BaxHTN study, in which a 2-mg dose of Baxfendy lowered systolic blood pressure by 9.8 mmHg versus placebo at 15 weeks, an effect that was statistically significant, according to an August 2025 publication in The New England Journal of Medicine.
Even a lower 1-mg dose resulted in an 8.7-mmHg improvement over placebo, AstraZeneca said on Monday.
Baxfendy, designed to be taken daily orally, works by blocking the aldosterone synthase enzyme, a molecule that induces sodium retention, which if left uncontrolled can elevate blood pressure. Baxfendy came to AstraZeneca in 2023, when the pharma acquired CinCor Pharma for $1.3 billion.
Trailing AstraZeneca is Mineralys Therapeutics, which is working on its own aldosterone synthase inhibitor lorundrostat, also in development for hypertension. The FDA accepted lorundostat’s new drug application in March, with a decision due in December.
