What Is Baxdrostat?
Baxdrostat is an investigational drug currently being studied in clinical trials. It is being developed by AstraZeneca. The provided trial data does not detail its specific mechanism of action or any current FDA approvals, meaning it is not yet available as a prescription medication. Baxdrostat is administered orally, typically as a tablet, once daily. Its development focuses on conditions related to blood pressure regulation and kidney function. Clinical trials are exploring its potential to manage various forms of hypertension and its effects in healthy individuals and those with chronic kidney disease. A total of 16 trials have been conducted or are ongoing, involving over 20,857 participants. The first trial began on 2023-07-27, with the latest trial starting on 2025-10-30. Baxdrostat is being investigated both as a standalone treatment and in combination with other medications like dapagliflozin.
Uses and Conditions Under Study
Baxdrostat is primarily being studied for its potential to treat various forms of high blood pressure. Hypertension, or high blood pressure, is a common condition that can lead to serious health problems if left untreated. Baxdrostat is being investigated in 4 trials specifically for hypertension. Additionally, it is being studied for more challenging forms of high blood pressure. This includes resistant hypertension, where blood pressure remains high despite treatment with multiple medications, and uncontrolled hypertension, where blood pressure is above target levels. Each of these conditions is being explored in 3 trials. The drug is also being studied in 3 trials for individuals with chronic kidney disease and hypertension, a population where managing blood pressure can be particularly complex.
Beyond hypertension, Baxdrostat is also being investigated for other specific conditions. It is being studied in 1 trial for heart failure, a condition where the heart cannot pump enough blood to meet the body's needs. Another 1 trial is exploring its use in primary hyperaldosteronism, a condition characterized by excessive production of aldosterone, a hormone that can raise blood pressure.
To understand how Baxdrostat works in the body and its safety profile, it is also being administered to healthy participants. These studies, involving 3 trials, help researchers evaluate the drug's absorption, distribution, metabolism, and excretion, as well as potential side effects, before it is widely used in patient populations.
Dosing
Baxdrostat has been studied in several dosage forms. It is primarily administered as a tablet, taken orally once daily. An oral solution of Baxdrostat has also been investigated. These forms allow for flexible administration depending on the study design or patient needs.
Various strengths of Baxdrostat have been explored in clinical trials. These include doses such as 1 mg and 2 mg. Some studies have also used a 10 mg radiolabeled form, [14C]-bexdrostat, which helps researchers track how the drug moves through the body. Baxdrostat has been studied as a standalone treatment and in combination with other medications. Combinations include Baxdrostat with dapagliflozin, and in specific pharmacokinetic studies, with ethinyl estradiol/levonorgestrel (EE/LNG) or itraconazole. These combination studies help assess potential drug interactions and safety profiles.
Clinical trials have also investigated how factors like food intake and liver function affect Baxdrostat. Studies have compared Baxdrostat tablets taken in both a fasted state and a fed state to understand absorption differences. Additionally, its pharmacokinetics have been assessed in individuals with normal hepatic function versus those with moderate hepatic impairment, to determine if dose adjustments might be necessary for patients with liver conditions.
Side Effects
In clinical trials for Baxdrostat, the most commonly reported side effects included nausea and vomiting. 6.3% of patients taking Baxdrostat experienced nausea, compared to 0.0% on placebo. Similarly, 6.3% of patients on Baxdrostat reported vomiting, while 0.0% on placebo experienced this.
Dizziness was reported by 6.3% of patients taking Baxdrostat, which was the same rate as those taking placebo (6.3%).
Other side effects reported in the Baxdrostat group included:
- Headache: 3.1% of patients on Baxdrostat experienced headache, compared to 12.5% on placebo.
- Hypotension (low blood pressure): 3.1% of patients on Baxdrostat experienced hypotension, compared to 6.3% on placebo.
- Lethargy (lack of energy): 3.1% of patients on Baxdrostat experienced lethargy, compared to 6.3% on placebo.
These side effect rates are based on one clinical trial involving 32 patients in the Baxdrostat treatment arm.
Clinical Trial Results
Uncontrolled Hypertension
A clinical trial (NCT06336356) investigated Baxdrostat in participants with uncontrolled hypertension, focusing on cortisol reserve. The study included 26 participants in the Baxdrostat 2 mg arm and 15 participants in the placebo arm.
One key outcome measured was the incidence of abnormal stimulated cortisol at Week 8. In this study, 0% of participants taking Baxdrostat 2 mg (0 out of 26 participants) experienced abnormal stimulated cortisol. Similarly, 0% of participants taking placebo (0 out of 15 participants) also experienced abnormal stimulated cortisol.
The trial also assessed the number of participants with serum total cortisol levels before and after an adrenocorticotropic hormone (ACTH) stimulation test. For this outcome, 0% of participants in the Baxdrostat 2 mg group (0 out of 26 participants) and 0% of participants in the placebo group (0 out of 15 participants) showed a specific change or met a defined threshold.
Regarding overall safety in this trial, 69.2% of participants in the Baxdrostat 2 mg group (18 out of 26 participants) experienced at least one adverse event. In comparison, 60.0% of participants in the placebo group (9 out of 15 participants) experienced at least one adverse event.
Currently Recruiting Trials
Baxdrostat is currently being investigated in several clinical trials for various conditions, offering opportunities for patients to contribute to medical research. These studies aim to understand how Baxdrostat works, its effectiveness, and its safety.
One ongoing Phase IIb study, NCT07222917, is evaluating Baxdrostat in combination with dapagliflozin for participants with chronic kidney disease and high blood pressure. This international, multicenter, and double-blind study seeks to measure the effect of this combination on albuminuria, a marker of kidney damage, and to assess overall safety. The trial aims to enroll approximately 218 participants.
For individuals with primary aldosteronism, a Phase III study, NCT07007793, is assessing the efficacy and safety of Baxdrostat. This multicenter, randomized, double-blind, placebo-controlled study will evaluate Baxdrostat's impact on reducing seated blood pressure and normalizing the Renin Angiotensin Aldosterone System. This trial plans to include around 250 participants.
Two large Phase III studies are also underway for patients with chronic kidney disease and heart failure. Study NCT06742723 is an international, multicenter, double-blind, placebo-controlled study investigating Baxdrostat in combination with dapagliflozin for chronic kidney disease and high blood pressure. It will assess the treatment's efficacy and safety on renal outcomes and cardiovascular mortality, with an enrollment target of 5,000 participants.
Finally, study NCT06677060 is a Phase III trial investigating heart failure and cardiovascular death with Baxdrostat in combination with dapagliflozin. This study is designed for men and women aged 40 years or older with type 2 diabetes, established cardiovascular disease, a history of hypertension, and other risk factors for heart failure. This significant trial is targeting an enrollment of 11,300 participants.
Where to Participate
Clinical trials for Baxdrostat are being conducted across a wide geographic area, with sites in 244 cities and 45 states. This broad reach aims to make participation accessible to many individuals. The general eligibility criteria for these studies typically include participants aged 18 to 40 years, of all genders. These trials are not seeking healthy volunteers but rather individuals with specific medical conditions related to the study.
Some of the cities with the most active recruiting sites include:
- Columbus, Ohio (7 sites)
- Kansas City, Missouri (5 sites)
- Dallas, Texas (5 sites)
- Boston, Massachusetts (5 sites)
- Chicago, Illinois (4 sites)
- San Francisco, California (4 sites)
- Houston, Texas (4 sites)
- Cincinnati, Ohio (4 sites)
- San Antonio, Texas (4 sites)
- Austin, Texas (4 sites)
Development Timeline
The development journey for Baxdrostat began with its first clinical trial on July 27, 2023, and continues with studies projected to run until at least October 30, 2025. AstraZeneca has been the sole sponsor for all 16 clinical trials conducted to date, demonstrating a consistent commitment to advancing this potential treatment.
Initially, Baxdrostat was explored for conditions such as IBS-C and hyperphosphatemia. Over time, the research pipeline expanded significantly, reflecting a growing understanding of the drug's potential. The focus broadened to include a range of cardiovascular and kidney-related conditions, such as chronic kidney disease and hypertension, resistant hypertension, uncontrolled hypertension, heart failure, and primary hyperaldosteronism.
The development has progressed through various phases, with 7 trials in Phase I, 2 in Phase II, and 7 now in Phase III, the final stage before potential regulatory approval. Across all studies, Baxdrostat has involved a substantial number of participants, with a total enrollment of 20,857 individuals, contributing valuable data to its ongoing evaluation.