Baxdrostat

AstraZeneca’s Baxfendy (baxdrostat) has been approved by the US FDA as a first-in-class aldosterone synthase inhibitor (ASI) to treat hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled. Baxfendy is a first-in-class, highly selective and potent ASI designed to lower blood pressure in a new way by specifically inhibiting the production of aldosterone, a hormone that raises blood pressure to unhealthy levels and increases the risk of heart and kidney problems. The approval was based on positive results from the BaxHTN phase 3 trial, with Baxfendy demonstrating statistically significant and clinically meaningful seated systolic blood pressure reduction at both 2mg and 1mg doses in patients with uncontrolled and resistant hypertension on two or more medications. Baxfendy was generally well-tolerated with no unanticipated safety findings. There are 1.4 billion people worldwide living with hypertension. In the US, approximately 50% of patients living with hypertension who are already taking multiple antihypertensive medications still struggle with persistently elevated blood pressure, which is a leading risk factor for cardiovascular disease and premature death. Hypertension is the most prevalent and significant modifiable cardiovascular risk factor worldwide, accounting for more deaths and disability than any other modifiable risk. Bryan Williams, Chair of Medicine at University College London and BaxHTN primary investigator, said: “Baxfendy’s novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension. “In addition, the nearly double-digit placebo-adjusted systolic blood pressure reduction achieved with Baxfendy is exciting and clinically meaningful for clinicians and patients. “Epidemiological data indicate that a 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit at AstraZeneca, said: “The approval of Baxfendy offers a much-needed, first-in-class innovation for people living with persistently uncontrolled hypertension who have not responded to or tolerated existing medicines. “In the US, about 23 million patients are uncontrolled despite being on two or more medicines for hypertension, which is a disease that has seen little therapeutic progress for the past two decades.”

Alongside Baxfendy, Fasenra has also secured a new approval with an FDA nod in certain hypereosinophilic syndrome patients. After an impressive phase 3 showing last fall, AstraZeneca’s wager on CinCor Pharma and its aldosterone synthase inhibitor (ASI) baxdrostat has continued to pay off.The FDA has given the all-clear to AZ’s baxdrostat—now christened Baxfendy—as the first ASI approved to treat patients with high blood pressure in the U.S. The FDA signed off on the drug for use in combination with other antihypertensive therapies in adults whose high blood pressure isn’t adequately controlled, according to a May 18 press release. AZ figures that roughly half of the people living with high blood pressure in the U.S. are already taking hypertension drugs but still struggle to keep their blood pressure in check and thus remain at risk of cardiovascular disease and early death. Globally, some 1.4 million people live with hypertension, by AZ’s reckoning. Enter Baxfendy, which leverages a novel mechanism of action to target high blood pressure by blocking the production of the hormone aldosterone, which is implicated in raising blood pressure to unhealthy levels and increasing the risk of heart and kidney issues. AZ got its hands on the drug by way of its $1.3 billion deal for developer CinCor Pharma back in 2023. AZ leadership has suggested Baxfendy could reach peak sales above $5 billion, and the medication forms a key part of the company’s plan to reach sales of $80 billion, buoyed by newer launches, by 2030. The FDA based its approval on data from the late-stage BaxHTN study, in which both 1- and 2-mg Baxfendy doses helped curb seated systolic blood pressure at statistically significant and clinically meaningful levels in patients with uncontrolled and resistant high blood pressure who were already taking two or more hypertension meds.Specifically, at week 12 of the study, Baxfendy 2-mg helped reduce patients’ blood pressure on average by nearly 10 mmHg when adjusted for placebo. The reduction in mean seated systolic blood pressure in the trial’s placebo cohort clocked in at 5.8 mmHg. In a separate phase 3 trial that read out last fall, Baxfendy reached reduction levels of 14 mmHg over a roughly three-month span. AZ has leveraged that trial—dubbed Bax24—in part to set its then-candidate apart from Mineralys’ experimental lorundrostat, which falls into the same ASI class as Baxfendy. The FDA is currently expected to weigh in on a potential approval for Mineralys’ asset by Dec. 22, the biotech said in March. “The approval of Baxfendy offers a much‑needed, first-in-class innovation for people living with persistently uncontrolled hypertension who have not responded to or tolerated existing medicines,” Ruud Dobber, EVP of AZ’s biopharmaceuticals business unit, said in a statement Monday, adding that some 23 million people are estimated to have uncontrolled high blood pressure in the United States. After setting the ambitious goal to hit revenues of $80 billion by 2030 back in 2024, AstraZeneca’s chief financial officer, Aradhana Sarin, affirmed that the target was “very much within reach” at the J.P. Morgan Healthcare Conference in January. Aside from the new entrant Baxfendy, AZ already boasts a strong cardiology presence thanks to medications like Farxiga, which is also cleared in type 2 diabetes and chronic kidney disease, alongside heart failure.Farxiga generated a whopping $8.4 billion last year, helping AstraZeneca pocket (PDF) total 2025 revenues of $58.7 billion.  Fasenra adds new niche Helping add to the momentum at AZ, the company also announced that its asthma and eosinophilic granulomatosis med Fasenra has been approved for a new use. The FDA has greenlit the antibody drug to treat both adults and kids ages 12 years and older with hypereosinophilic syndrome (HES) that doesn’t have an identifiable non-hematologic secondary cause, according to a separate AZ release Monday. HES consists of a group of rare disorders marked by persistently high levels of eosinophils, a type of white blood cell, with evidence of eosinophil-mediated organ or tissue damage, according to AZ. The condition can lead to progressive organ damage over time and may end in death if left untreated. In the late-stage NATRON study, Fasenra delayed patients’ time to first HES flare and significantly reduced the risk of an initial flare by 65% compared to placebo, AZ said in its release.  Fasenra has also brought home blockbuster sales for AZ in recent years, primarily through its clearance as an add-on maintenance treatment for severe eosinophilic asthma, as well as its use as a treatment for eosinophilic granulomatosis with polyangiitis. In 2025, sales of the drug reached nearly $2 billion, signaling a 16% climb over 2024 at constant exchange rates.