Baxfendy (baxdrostat) / Roche, AstraZeneca - LARVOL DELTA

Resistant Hypertension: State of the Art Review. (PubMed, Clin J Am Soc Nephrol) - "Newly FDA-approved agents aprocitentan and baxdrostat provide additional pharmacologic options for patients inadequately controlled on existing therapy. Future management is likely to move toward more precise, phenotype-guided treatment integrating ambulatory blood pressure patterns, renin-aldosterone biology, volume status, kidney function, and cardiometabolic comorbidities. Improved diagnostic precision and mechanism-based treatment strategies may reduce persistent treatment gaps and improve long-term cardiovascular and kidney outcomes."

Journal • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Diabetes • Genetic Disorders • Heart Failure • Hypertension • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus

Kidney Safety and Electrolyte Effects of Baxdrostat in Uncontrolled Hypertension: A Systematic Review and Meta-Analysis (KIDNEY WEEK 2026) - "The marked increase in hyperkalemia despite absence of major renal decline identifies potassium dysregulation as the principal renal safety concern with aldosterone synthase inhibition. These findings support close potassium surveillance, particularly in patients with impaired renal reserve."

Retrospective data • Review • Cardiovascular • Hypertension

Efficacy and Safety of Selective Aldosterone Synthase Inhibitors in Uncontrolled Hypertension: A Systematic Review and Network Meta-Analysis (KIDNEY WEEK 2026) - "Background Selective aldosterone synthase inhibitors (ASIs), including baxdrostat and lorundrostat, target CYP11B2 while sparing cortisol synthesis, offering a mechanism-based therapeutic approach for patients with uncontrolled or resistant hypertension. Careful dose selection and monitoring of renal function and electrolytes are warranted. Summary of Efficacy and Safety Results"

Retrospective data • Review • Cardiovascular • Heart Failure • Hypertension • Hypotension

Baxdrostat Effects in CKD with Uncontrolled Hypertension: Biomarker Analysis Results from the Phase 2 FigHTN Trial (KIDNEY WEEK 2026) - "These data suggest that the initial eGFR reduction is attributable to a reversible hemodynamic effect rather than structural kidney damage. Phase 3 trials investigating effects of baxdrostat with dapagliflozin on CKD progression and cardio-kidney protection are ongoing."

Biomarker • P2 data • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Hypertension • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus • CST3 • KIM1 • LCN2

Baxdrostat/Dapagliflozin vs. Placebo/Dapagliflozin in Adults with CKD with Hypertension: BaxDuo-Arctic Phase 3 Study Design and Baseline Characteristics (KIDNEY WEEK 2026) - P3 | "Mean (standard deviation) eGFR and sSBP were 57.3 (15.7) mL/min/1.73 m 2 and 140.8 (13.9) mmHg, respectively. Conclusion BaxDuo-Arctic will assess the efficacy and safety of baxdrostat/dapagliflozin versus placebo/dapagliflozin on CKD progression in patients with CKD with hypertension."

Clinical • P3 data • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Glomerulonephritis • Heart Failure • Hypertension • Hypotension • Lupus Nephritis • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Sustained Reversal of Hyperaldosteronism After Aldosterone Synthase Inhibitor Exposure in a Patient with Primary Aldosteronism and CKD: Implications for Targeted Adrenal Therapy (KIDNEY WEEK 2026) - "Case Description A 46-year-old male with CKD and PA (plasma aldosterone 18 ng/dl, renin activity 0.24 ng/ml/hr) was enrolled in the SPARK phase 2a trial of baxdrostat in PA...In 12/2025, the BP was 119/79 mmHg, on lisinopril 20 mg daily, nifedipine 60 mg daily, and carvedilol 25 mg twice daily...Prior animal studies have shown cellular apoptosis of the zona glomerulosa following ASI treatment, providing a potential mechanistic explanation for our observation. This case represents a novel clinical observation which may inspire further mechanistic research and inform the long-term management of PA."

Clinical • Acute Kidney Injury • Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Hypertension • Nephrology • Renal Disease

Emerging Therapeutics in Hypertension: Evidence, Clinical Readiness, and Implementation. (PubMed, Curr Probl Cardiol) - "The endothelin receptor antagonist aprocitentan and the aldosterone synthase inhibitor baxdrostat both lowered systolic BP in resistant hypertension and are now approved in the United States. Lorundrostat similarly reduced BP in phase 2 trials and is under FDA review. Angiotensinogen-directed RNA interference with zilebesiran produced durable BP lowering with infrequent dosing, although the effect was attenuated on background renin-angiotensin blockade, and the KARDIA-3 primary endpoint was not met. Gene transfer and genome editing remain preclinical, and multi-omics treatment selection is not yet established. No new agent or device has yet demonstrated a reduction in cardiovascular or kidney events, so the most credible near-term gains will come from integrating validated measurement, durable mechanism-directed therapy, and equitable implementation rather than any single therapy."

Journal • Review • Cardiovascular • Gene Therapies • Hypertension • Nephrology

Aldosterone Synthase Inhibitors: Emerging Therapeutic Strategies in Resistant Hypertension. (PubMed, Life (Basel)) - "Recent clinical trials of baxdrostat, lorundrostat, vicadrostat, and dexfadrostat have demonstrated clinically meaningful reductions in blood pressure and albuminuria with acceptable safety profiles. Based on the positive trial data, baxdrostat has become the first in class ASI to be approved by regulatory authorities for management of uncontrolled hypertension."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Endocrine Disorders • Heart Failure • Hypertension • Nephrology • Renal Disease • CYP11B1

Pharmacokinetics of novel drugs for the treatment of Diabetic nephropathy. (PubMed, Expert Opin Drug Metab Toxicol) - "Evidence was synthesized for sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide-1 receptor agonists (GLP-1RA), dual incretin agonists, nonsteroidal mineralocorticoid receptor antagonists (nsMRA), endothelin receptor antagonists (ERA), aldosterone synthase inhibitors (vicadrostat, baxdrostat, and lorundrostat), avenciguat, and ziltivekimab, emphasizing exposure, clearance, metabolism, elimination, and dosing implications. In reduced kidney function, SGLT2i show modest exposure increases but attenuated glucose-lowering effects, finerenone shows modest exposure increases despite minimal renal clearance, and ERA may have larger increases that narrow the therapeutic window. Newer incretin therapies generally maintain stable exposure, while eGFR alone may incompletely capture PK risk because uremia, altered protein binding, and nonrenal clearance can influence exposure. The next advance is likely to be drug-specific decision support integrating estimated..."

Journal • PK/PD data • Review • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Comparative Efficacy of Aldosterone-Related Sodium-Retention Pathway Therapies for Resistant Hypertension: A Drug-Level Network Meta-Analysis of Randomized Controlled Trials. (PubMed, J Clin Hypertens (Greenwich)) - "In the primary drug-level analysis, amiloride, spironolactone, baxdrostat, eplerenone, and lorundrostat significantly reduced office systolic BP compared with placebo, with mean differences (MDs) of -14.08, -10.78, -9.09, -8.14, and -6.80 mmHg, respectively. Osilodrostat showed a statistically uncertain effect, with an MD of -2.61 mmHg...MRAs remain the established reference add-on therapy, whereas newer ASIs and amiloride may represent pathway-based alternatives for selected patients. Trial Registration: INPLASY202670099."

Clinical • Journal • Retrospective data • Cardiovascular • Hypertension

Efficacy and Safety of Baxdrostat in Hypertension: A GRADE-Assessed Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Ann Pharmacother) - "Baxdrostat significantly improves blood pressure control in patients with uncontrolled or resistant hypertension but increases the risk of hyperkalemia and other electrolyte disturbances. These findings strengthen the evidence for selective aldosterone synthase inhibition as a therapeutic approach for aldosterone-mediated hypertension and suggest that baxdrostat may provide an additional treatment option, particularly for patients who remain uncontrolled or cannot tolerate mineralocorticoid receptor antagonists. However, the increased risk of hyperkalemia and the limited duration of available trials highlight the need for careful electrolyte and renal monitoring and further studies evaluating long-term cardiovascular outcomes and comparisons with established therapies."

Journal • Retrospective data • Review • Cardiovascular • Heart Failure • Hypertension

Efficacy and Safety of Baxdrostat for Hypertension: A Systematic Review and Meta-Analysis of Three Phase 2/3 Randomized Controlled Trials (AHA 2026) - "Abstract is embargoed at this time."

P2/3 data • Retrospective data • Review • Cardiovascular • Hypertension

Blood Pressure-Lowering Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension: A Systematic Review, Meta-Analysis, and Dose-Response Analysis with Trial Sequential Analysis (AHA 2026) - "Abstract is embargoed at this time."

Retrospective data • Review • Cardiovascular • Hypertension

Baxdrostat Efficacy and Safety According to Baseline Clinical Characteristics: Subgroup Analyses of the BaxHTN Trial (AHA 2026) - "Abstract is embargoed at this time."

Clinical • Cardiovascular • Hypertension

Efficacy and Safety of Baxdrostat in Resistant Hypertension: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (AHA 2026) - "Abstract is embargoed at this time."

Retrospective data • Review • Cardiovascular • Hypertension

EliXir: Baxdrostat and Molecular Imaging of Adrenal Cytoreduction in Primary Aldosteronism (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Queen Mary University of London

New trial • Cardiovascular • Endocrine Disorders • Hypertension

Long-term efficacy and safety of baxdrostat in patients with uncontrolled or resistant hypertension: results from the BaxHTN phase 3 trial (ESC 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Cardiovascular • Hypertension

24-hour blood pressure burden: aldosterone, cardiorenal risk, and the next generation of blood pressure control (ESC 2026) - "Sponsored by AcademicCME - Supported by an independent educational grant from AstraZeneca To review the physiologic functions of aldosterone and explain how aldosterone excess and dysregulation contribute to sustained day and night time hypertension, nocturnal blood pressure elevation, morning surge, blood pressure variability, and the cumulative 24 hour blood pressure burden that drives cardiovascular and cardiorenal organ damage; To describe how 24 hour ambulatory blood pressure monitoring detects and confirms biologically meaningful blood pressure phenotypes, including nocturnal hypertension, non and reverse dipping, morning surge, and high blood pressure variability, and correlate these ambulatory blood pressure monitoring detected patterns with underlying mechanisms such as renin-angiotensin-aldosterone system activation, aldosterone excess, sodium retention, obstructive sleep apnel, and sympathetic overactivity; To summarise 24 hour and nocturnal blood pressure..."

Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension

BaxDuo-Baltic: 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. (clinicaltrials.gov) - P2 | N=222 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | Trial completion date: May 2027 ➔ Dec 2026 | Trial primary completion date: May 2027 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Renal Disease

Effect of diuretic dose on baxdrostat efficacy and safety in uncontrolled and resistant hypertension: a post hoc analysis of the BaxHTN trial (ESC 2026) - "In this analysis, patients were categorised by diuretic dose into low (≤0.5 defined daily dose [DDD]: e.g. indapamide ≤1.25 mg; chlortalidone ≤12.5 mg; hydrochlorothiazide ≤12.5 mg) and standard (defined as >0.5 DDD for this analysis) dose groups. Safety profiles were similar between groups, including discontinuation due to hyperkalaemia. Further data are needed to understand baxdrostat’s effect in patients without diuretics."

Clinical • Retrospective data • Cardiovascular • Hypertension

Baxdrostat for treatment of uncontrolled and resistant hypertension: a meta-analysis and systematic review (ESC 2026) - "Baxdrostat was effective in lowering systolic blood pressure, but increased the risk of hyperkalemia. These results support it as an alternative therapy for uncontrolled and resistant hypertension, with cautious use in patients at risk for hyperkalemia. New evidence is needed for long-term cardiovascular and renal outcomes, as well as comparisons with mineralocorticoid receptor antagonists and other ASIs, concerning efficacy and safety."

Retrospective data • Review • Cardiovascular • Hypertension

Efficacy and safety of baxdrostat in resistant and uncontrolled hypertension: a systematic review and meta-analysis of randomised controlled trials (ESC 2026) - "Baxdrostat demonstrated clinically meaningful, consistent, and dose-dependent antihypertensive efficacy in resistant or uncontrolled hypertension. Although hyperkalaemia risk is increased, particularly at higher doses, it remains amenable to clinical monitoring and management. These findings support baxdrostat as a promising and viable therapeutic strategy to broaden options for patients who are difficult to treat."

Retrospective data • Review • Cardiovascular • Hypertension

Baxdrostat: First Approval. (PubMed, Drugs) - "On 15 May 2026, baxdrostat received its first approval in the USA for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure (BP) in adults who are not adequately controlled on other agents. This article summarizes the milestones in the development of baxdrostat leading to this first approval for hypertension."

Journal • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Endocrine Disorders • Heart Failure • Hypertension • Hypotension • Nephrology • Renal Disease

Dose-response efficacy and safety of the aldosterone synthase inhibitor baxdrostat in resistant hypertension: a systematic review and network meta-analysis. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Ambulatory rankings did not establish superiority of 1 mg over 2 mg, and both higher doses significantly increased hyperkalemia risk. Larger, longer-term studies are required."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Hypertension

Efficacy and Safety of Baxdrostat for Patients With Uncontrolled or Resistant Hypertension: A Systematic Review and Meta-Analysis. (PubMed, Cardiol Rev) - "However, baxdrostat was associated with higher adverse events compared with the placebo. Baxdrostat lowers blood pressure and aldosterone levels in uncontrolled and resistant hypertension but increases potassium and modestly reduces eGFR, supporting careful laboratory monitoring and longer trials to evaluate long-term clinical outcomes."

Journal • Retrospective data • Cardiovascular • Hypertension