After showing impressive Phase 3 results last fall, AstraZeneca’s bet on Cincor Pharma and its aldosterone synthase inhibitor (ASI) baxdrostat continues to pay off.
The FDA has given full approval to AZ’s Baxdrostat (now named Baxfendi) as the first ASI approved to treat patients with hypertension in the United States.According to a May 18 press release, the FDA has approved the drug’s use in conjunction with other antihypertensive therapies for adults whose high blood pressure is not adequately controlled.
AZ estimates that about half of people living with high blood pressure in the United States are already taking high blood pressure medications, but they still struggle to keep their blood pressure under control, which leaves them at risk for cardiovascular disease and premature death. According to estimates by AZ, approximately 1.4 million people worldwide live with high blood pressure.
Baxfendy utilizes a novel mechanism of action that targets high blood pressure by blocking the production of aldosterone, a hormone responsible for raising blood pressure to unhealthy levels and increasing the risk of heart and kidney problems.
AZ acquired the drug in 2023 through a $1.3 billion deal with developer Cincor Pharma. AZ management has indicated that Baxfendi could reach peak sales of more than $5 billion, and the drug is a key part of the company’s plan to reach $80 billion in sales by 2030 through new product launches.
The FDA based its approval on data from the late-stage Baxfendy trial. In this study, both 1 mg and 2 mg doses of Baxfendy helped control sitting systolic blood pressure at statistically significant and clinically meaningful levels in patients with uncontrolled, resistant hypertension who were already taking two or more hypertension medications.
Specifically, during week 12 of the study, Baxfendy 2 mg helped lower patients’ blood pressure by an average of nearly 10 mmHg when adjusted for placebo. The mean seated systolic blood pressure reduction in the trial’s placebo cohort was 5.8 mmHg.
In another Phase 3 study conducted last fall, Baxfendy reached a reduction level of 14 mmHg in about three months. AZ leveraged the candidate at the time in part to distinguish its test, called Bax24, from Minyeralys’ experimental rolandrostat, which falls in the same ASI class as Baxfendy.
Mineralis, a biotechnology company, announced in March that the FDA is currently expected to consider potential approval of Mineralis’ assets by Dec. 22.
“The approval of Baxfendi provides a much-needed first-in-class innovation for people with chronic uncontrolled hypertension who are not responding to or cannot tolerate existing medications,” Ruud Dobber, vice president of Arizona’s biopharmaceutical business, said in a statement Monday, adding that approximately 23 million people in the United States are estimated to have uncontrolled hypertension.
After setting an ambitious goal in 2024 to reach $80 billion in sales by 2030, AstraZeneca Chief Financial Officer Aradhana Sarin asserted at the JPMorgan Healthcare Conference in January that the goal was “quite within reach.”
Aside from new entrant Baxfendy, Arizona already has a strong presence in cardiology thanks to drugs like Farxiga, which treats type 2 diabetes and chronic kidney disease in addition to heart failure.
Farxiga generated a whopping $8.4 billion last year and contributed to AstraZeneca Pocket (PDF)’s 2025 total revenue of $58.7 billion.
Fasenra adds new niche market
Furthering the momentum in Arizona, the company also announced the approval of a new use for Fasenra, a treatment for asthma and eosinophilic granulomatosis.
According to another AZ release on Monday, the FDA has given the green light to an antibody drug to treat both adults and children 12 and older with hypereosinophilic syndrome (HES) where no secondary non-blood cause can be identified.
According to AZ, HES consists of a group of rare diseases characterized by persistently high levels of eosinophils, a type of white blood cell, and there is evidence of eosinophil-mediated organ and tissue damage. This condition can cause progressive organ damage over time and can be fatal if left untreated.
In the late-stage NATRON trial, Fasenra delayed the time to first HES relapse in patients and significantly reduced the risk of early relapse by 65% compared to placebo, AZ said in a statement.
Fasenra has also brought blockbuster sales to AZ in recent years, primarily through its approval as an add-on maintenance therapy for severe eosinophilic asthma and its use as a treatment for eosinophilic granulomatosis with polyangiitis.
In 2025, sales of the drug will reach nearly $2 billion, representing a 16% increase compared to 2024 at constant exchange rates.
