Baxdrostat

Baxdrostat is an inhibitor of human aldosterone synthase. Aldosterone contributes to hypertension by promoting the retention of sodium and water by the kidneys, which increases blood volume and, consequently, raises blood pressure.

• BAXFENDY, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure in adults who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.ICD-10: I10

• None. None.contraindicated

• Consider the patient’s risk of hyperkalemia and hyponatremia before initiating BAXFENDY. (2.1) • Recommended dosage is 2 mg orally once daily. (2.2) • For patients at increased risk of hyperkalemia or hyponatremia, the recommended dosage is 1 mg once daily. (2.2) • Take with or without food. (2.3) 2.1 Testing Prior to and After Initiation of BAXFENDY Consider the patient’s risk of hyperkalemia and hyponatremia before initiating BAXFENDY. Assess serum potassium and sodium before initiation of BAXFENDY and periodically thereafter. Correct serum potassium and sodium abnormalities prior to initiation of BAXFENDY [see Warnings and Precautions (5.1 , 5.2 )] . 2.2 Recommended Dosage The recommended dosage of BAXFENDY is 2 mg orally once daily. For patients at increased risk of hyperkalemia or hyponatremia, the recommended dosage is 1 mg orally once daily [see Warnings and Precautions (5.1 , 5.2) ] . 2.3 Administration Instructions Swallow tablets whole. Do not cut, crush, or chew tablets. BAXFENDY may be taken with or without food. If a dose is missed, take the next dose at the usual time. Do not take a double dose on the same day.

• Hyperkalemia : Assess serum potassium before initiation and periodically thereafter. Assess more frequently in patients at increased risk of hyperkalemia. ( 5.1 ) • Hyponatremia : Assess serum sodium before initiation and periodically thereafter. Assess more frequently in patients at increased risk of hyponatremia. ( 5.2 ) 5.1 Hyperkalemia BAXFENDY can cause hyperkalemia [see Adverse Reactions (6.1) ] . Assess serum potassium prior to initiation of BAXFENDY and monitor periodically during treatment. Correct serum potassium abnormalities prior to initiation of BAXFENDY [see Dosage and Administration (2.1 , 2.2) ] . More frequent monitoring is recommended for patients at increased risk of hyperkalemia (e.g., patients ≥ 65 years of age, those with diabetes mellitus or chronic kidney disease, and those receiving concomitant medications that increase serum potassium) [see Drug Interactions (7.1) and Geriatric Use (8.5) ] . If hyperkalemia occurs, treat hyperkalemia and consider interrupting or discontinuing BAXFENDY. Consider more frequent monitoring of serum potassium in patients who restart BAXFENDY after experiencing hyperkalemia. Permanently discontinue BAXFENDY if clinically significant hyperkalemia recurs. 5.2 Hyponatremia BAXFENDY can cause hyponatremia [see Adverse Reactions (6.1) ] . Assess serum sodium prior to initiation of BAXFENDY and monitor periodically during treatment. Correct serum sodium abnormalities prior to initiation of BAXFENDY [see Dosage and Administration (2.1 , 2.2 )] .

The following clinically significant adverse reactions are also discussed elsewhere in the labeling: • Hyperkalemia [see Warnings and Precautions (5.1) ] • Hyponatremia [see Warnings and Precautions (5.2) ] The most common adverse reaction (more frequent than placebo and ≥ 5% in BAXFENDY-treated patients) was hyperkalemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of BAXFENDY was evaluated over 12 weeks using the randomized, double-blind, placebo-controlled periods from three clinical trials in patients with hypertension not adequately controlled on other antihypertensive medications. Three of these trials [BaxHTN (NCT06034743), BrigHTN (NCT04519658), Bax24 (NCT06168409)] evaluated BAXFENDY 2 mg as add-on treatment and two trials [BaxHTN, BrigHTN] evaluated BAXFENDY 1 mg as add-on treatment. These data reflect exposure of 441 patients to BAXFENDY 2 mg and 333 patients to BAXFENDY 1 mg, with a mean treatment duration of 80 days for both BAXFENDY 2 mg and 1 mg. Analyses in this section are based on the 12‑week periods in these three trials.

8.1 Pregnancy Risk Summary There are no available data on the use of BAXFENDY during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcome. Hypertension during pregnancy poses a risk to the mother and fetus (see Clinical Considerations) . Although studies in animals have shown embryo-fetal toxicity at baxdrostat exposures > 29 times the human exposure at the clinical dose of 2 mg, the clinical significance of these findings is unclear (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Report any pregnancies while treated with BAXFENDY to AstraZeneca at 1-800-236-9933. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the risk for adverse maternal outcomes including pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).

Metabolism

Baxdrostat geometric mean maximum plasma concentration (C max ) was 19 ng/mL (%CV: 5.4) and the geometric mean area underneath the time concentration curve from time 0 to infinity (AUC 0–inf ) was 711 h*ng/mL (%CV: 32) following a single 2 mg dose. Baxdrostat AUC and C max increased in a dose‑proportional manner for the 1 and 2 mg doses in patients with hypertension, and steady state was reached by Day 8.

BAXFENDY did not show any toxicity in healthy subjects at single oral doses up to 360 mg. In the event of an overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. It is also reasonable to employ supportive measures as dictated by the patient’s clinical status. The removal of baxdrostat by hemodialysis has not been studied.

• May 15, 2026NDANDA219878Astrazeneca Ab

The 10 most recently updated of 20 ClinicalTrials.gov registrations naming Baxdrostat as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
  Recruiting · Phase 3 · Interventional · 5,000 enrolled · AstraZeneca
  NCT06742723updated 2026-06-02
• Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
  Recruiting · Phase 3 · Interventional · 11,300 enrolled · AstraZeneca
  NCT06677060updated 2026-05-18
• A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.
  Recruiting · Phase 2 · Interventional · 218 enrolled · AstraZeneca
  NCT07222917updated 2026-05-18
• A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.
  Active not recruiting · Phase 3 · Interventional · 2,554 enrolled · AstraZeneca
  NCT06268873updated 2026-05-12
• A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
  Completed · Phase 3 · Interventional · 326 enrolled · AstraZeneca
  NCT06344104updated 2026-04-21
• A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
  Recruiting · Phase 3 · Interventional · 250 enrolled · AstraZeneca
  NCT07007793updated 2026-04-20
• A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
  Completed · Phase 3 · Interventional · 218 enrolled · AstraZeneca
  NCT06168409updated 2026-02-06
• A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension
  Completed · Phase 2 · Interventional · 48 enrolled · AstraZeneca
  NCT06336356updated 2025-12-17
• A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
  Completed · Phase 3 · Interventional · 796 enrolled · AstraZeneca
  NCT06034743updated 2025-11-10
• A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Participants
  Completed · Phase 1 · Interventional · 28 enrolled · AstraZeneca
  NCT06194032updated 2025-04-25

Frequently asked questions

How does Baxdrostat work?

Baxdrostat is an inhibitor of human aldosterone synthase. Aldosterone contributes to hypertension by promoting the retention of sodium and water by the kidneys, which increases blood volume and, consequently, raises blood pressure.

What is Baxdrostat used for?

According to FDA labeling, Baxdrostat carries indications including: BAXFENDY, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure in adults who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Baxdrostat?

Baxdrostat is classified as Other antihypertensives.

What are the brand names for Baxdrostat?

Baxdrostat is marketed under brand names including Baxfendy.

What are the contraindications for Baxdrostat?

Baxdrostat labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.