baxdrostat (CIN-107) / Roche, AstraZeneca - LARVOL DELTA

Diabetes Mellitus and Chronic Kidney Disease: The Future Is Being Surpassed. (PubMed, J Clin Med) - "(5) The mineralocorticoid receptor antagonist (MRA) finerenone has been tested in RCTs as a kidney protective agent...Many novel agents-many of them proven not only for DM management but also for the treatment of obesity with or without DM or heart failure (HF)-are now in development and may be added to the five classical pillars: other non-steroidal MRA (balcinrenone); aldosterone synthase inhibitors (baxdrostat and vicadrostat); other GLP-1 RA (tirzepatide, survodutide, retatrutide, and cagrilintide); ET1 R antagonists, (zibotentan); and soluble guanylate cyclase activators (avenciguat). These new agents aim to slow disease progression further and reduce cardiovascular risk. Future strategies rely on integrated, patient-centered approaches and personalized therapy to curb renal disease and its related complications."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Diabetes • Diabetic Nephropathy • Genetic Disorders • Heart Failure • Metabolic Disorders • Nephrology • Obesity • Renal Disease

AstraZeneca’s new drug application for baxdrostat has been accepted for priority review by the US Food and Drug Administration (FDA) to treat adults with hard-to-control hypertension. (Investing.com) - "The FDA set a Prescription Drug User Fee Act date for the second quarter of 2026, when a decision on the application is expected. The submission was based on positive results from the BaxHTN Phase III clinical trial, which demonstrated statistically significant and clinically meaningful reduction in systolic blood pressure among patients."

FDA filing • PDUFA • Priority review • Hypertension

Efficacy and safety of selective aldosterone synthase inhibitors in uncontrolled hypertension: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Clin Hypertens) - "Larger RCTs with extended follow-up periods are warranted to establish long-term evidence. PROSPERO Identifier: CRD420251108664."

Journal • Retrospective data • Review • Cardiovascular • Hypertension

BaxDuo-Pacific: 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 (clinicaltrials.gov) - P3 | N=5000 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Apr 2030 ➔ Dec 2029 | Trial primary completion date: Apr 2030 ➔ Dec 2029

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

BP and Urine Albumin-to-Creatinine Ratio Lowering by Baxdrostat in Participants in the FigHTN Trial (KIDNEY WEEK 2025) - P2 | "Results within subgroups were generally consistent with the overall results (Figures 1, 2), with overlapping 95% CI and interaction p-values supporting consistent reduction in SBP and UACR across subgroups. Conclusion Baxdrostat consistently reduced SBP and UACR among subgroups of participants with CKD and HTN."

Cardiovascular • Chronic Kidney Disease • Diabetes • Hypertension • Metabolic Disorders • Renal Disease • Type 2 Diabetes Mellitus

NEJM: Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension (KIDNEY WEEK 2025) - "Funding ASN thanks JAMA and NEJM for assistance with this session."

Clinical • Cardiovascular • Hypertension

BaxHTN: 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 (clinicaltrials.gov) - P3 | N=796 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension

Effect of Baxdrostat on 24-Hour Average Ambulatory Blood Pressure in Patients with Resistant Hypertension: The Bax24 Trial (AHA 2025) - P3 | "Ambulatory BP was measured every 20 minutes during daytime and every 30 minutes during nighttime at baseline and Week 12.Power Calculations: 212 patients provided 88% statistical power to detect a treatment effect of 6 mmHg difference in change from baseline in 24h-ASBP at Week 12, assuming a standard deviation of 12 mmHg and 25% dropout rate, using a two-sample t-test (two-sided alpha level of 0.05).Primary End Point: Change in 24h-ASBP from baseline to Week 12.Key Secondary End Points: Change from baseline to Week 12 in: 1) nighttime/daytime ASBP; 2) 24h ambulatory diastolic BP; and 3) sOSBP.Outcomes: Results for the primary and secondary end points, and key safety/tolerability findings, will be presented. The results will complement baxdrostat trials based on changes in sOSBP and provide further evidence of baxdrostat's BP lowering efficacy in patients with confirmed rHTN."

Clinical • Cardiovascular • Hypertension

Aldosterone synthase inhibitors: a new group of drugs for influencing blood pressure in the renin-angiotensin-aldosterone system (PubMed, Inn Med (Heidelb)) - "Of the active ingredients two (baxdrostat and lorundrostat) have already been shown to be very successful in phase 3 trials, demonstrating that the use of both drugs can further reduce systolic blood pressure by approximately 10 mm Hg in complicated blood pressure situations. As expected, blocking the formation of aldosterone increases potassium levels but this has not caused any clinically unmanageable problems. This is a promising group of drugs for the treatment of complicated blood pressure but also perhaps for early treatment."

Journal • Review • Cardiovascular • Hypertension

Baxdrostat: the new kid on the block for the treatment of resistant hypertension. (PubMed, J Cardiovasc Pharmacol) - No abstract available

Journal • Cardiovascular • Hypertension

In brief: Primary aldosteronism screening in patients with hypertension. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Endocrine Disorders • Hypertension

Evaluating Aldosterone Synthase Inhibitors in Hypertension: A Meta-Analysis of Efficacy, Safety, and Subgroup Outcomes Across Novel Agents (AHA 2025) - "Four different ASIs - lorundrostat, osilodrostat, baxdrostat, and vicadrostat- were evaluated across the included trials. ASIs appear to be effective and well-tolerated antihypertensive agents, offering significant BP reduction across diverse patient groups, with lorundrostat demonstrating the strongest efficacy. These findings support further large-scale head-to-head trials to better define their role in hypertension management."

Retrospective data • Cardiovascular • Chronic Kidney Disease • 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=218 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Renal Disease

Baxdrostat: A Next-Generation Aldosterone Synthase Inhibitor Offering New Hope in Resistant Hypertension. (PubMed, Biomolecules) - "It is considered safe for use with other medications, including metformin. Ongoing trials are investigating its potential in patients with chronic kidney disease (CKD) and primary hyperaldosteronism (PA). Baxdrostat represents a promising therapeutic option for aldosterone-driven hypertension, especially in patients unresponsive to standard treatments."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Hypertension • Nephrology • Pulmonary Arterial Hypertension • Renal Disease

Baxdrostat and the future of aldosterone-targeted therapy. (PubMed, Hypertens Res) - No abstract available

Journal • Cardiovascular • Endocrine Disorders • Hypertension

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. (clinicaltrials.gov) - P3 | N=2455 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Renal Disease

Comparative efficacy and safety of aldosterone synthase inhibitors in hypertension: a Bayesian network meta-analysis of randomised controlled rials. (PubMed, Open Heart) - "ASIs significantly reduce BP with generally favourable tolerability. Osilodrostat and Baxdrostat demonstrated the most consistent efficacy across outcomes, while Lorundrostat also showed potential benefit. This analysis supports the use of ASIs as effective alternatives for BP reduction. Further large-scale and long-term RCTs are needed to validate these findings and guide clinical decision-making."

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

More about the Phase 2a Study of Baxdrostat in Primary Aldosteronism. (PubMed, N Engl J Med) - No abstract available

Journal • P2a data • Endocrine Disorders

More about the Phase 2a Study of Baxdrostat in Primary Aldosteronism. Reply. (PubMed, N Engl J Med) - No abstract available

Journal • P2a data • Endocrine Disorders

No Evidence of QTc Interval Prolongation With Baxdrostat Treatment: Concentration-QTc Modeling Assessment. (PubMed, Pharmacol Res Perspect) - P1 | "In the TQT study, 28 participants were randomized to one of four treatment sequences (each n = 7) of baxdrostat 16 mg, baxdrostat 32 mg, placebo and open-label moxifloxacin 400 mg. Pharmacokinetic data for the 16 and 32 mg doses in the TQT study were as expected, and both doses were well tolerated. These data illustrate that baxdrostat is not associated with the risk of QT-interval prolongation at therapeutic and supra-therapeutic concentrations."

Clinical • Journal • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Renal Disease • STAT3

Bax24: A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension (clinicaltrials.gov) - P3 | N=218 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension

Baxdrostat beneficial in uncontrolled or resistant hypertension. (PubMed, Nat Rev Cardiol) - No abstract available

Journal • Cardiovascular • Hypertension

Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. (PubMed, J Am Soc Nephrol) - No abstract available

Clinical • Journal • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Renal Disease

The Emerging Role of Aldosterone Synthase Inhibitors in Overcoming Renin-Angiotensin-Aldosterone System Therapy Limitations: A Narrative Review. (PubMed, Card Fail Rev) - "Early clinical trials of ASIs (baxdrostat, lorundrostat, vicadrostat, dexfadrostat phosphate, JX09) report significant reductions in aldosterone, blood pressure and albuminuria, with promising safety. Challenges include ensuring high selectivity, mitigating hyperkalaemia and establishing long-term benefits. Ongoing Phase III trials will clarify their efficacy, safety and synergy with additional therapies - including sodium-glucose cotransporter 2 inhibitors - and clinical outcomes, positioning ASIs as an important advance in renin-angiotensin-aldosterone system modulation."

Journal • Review • Cardiovascular • Hypertension • Renal Disease

BaxPA: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Disorders