vicadrostat (BI 690517) / Boehringer Ingelheim - LARVOL DELTA

Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS) (clinicaltrialsregister.eu) - P1/2 | N=100 | Not yet recruiting | Sponsor: Universitair Medisch Centrum Groningen

New P1/2 trial • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Heart Failure • Nephrology • Renal Disease

1378-0027: A study in healthy people to test how vicadrostat affects the heart (clinicaltrialsregister.eu) - P1 | N=45 | Not yet recruiting | Sponsor: Boehringer Ingelheim International GmbH

New P1 trial

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=416 | Recruiting | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Chronic Kidney Disease • Nephrology • Renal Disease

EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) (clinicaltrials.gov) - P3 | N=11000 | Recruiting | Sponsor: Boehringer Ingelheim | N=2650 ➔ 11000

Enrollment change • Chronic Kidney Disease • Congestive Heart Failure • Nephrology • Renal Disease

EFFICACY AND SAFETY OF ALDOSTERONE SYNTHASE INHIBITORS IN HYPERTENSION: A META-ANALYSIS OF NINE RANDOMIZED CONTROLLED TRIALS (ACC 2026) - " We systematically identified nine randomized controlled trials (RCTs) evaluating ASIs (osilodrostat, vicadrostat, lorundrostat, baxdrostat) compared with placebo. ASIs lower BP effectively, even in resistant hypertension, with acceptable safety but a moderate hyperkalemia risk, warranting further large-scale outcome trials."

Retrospective data • Cardiovascular • Hypertension

Improving CKD outcomes through research collaboratives in primary care: A quality improvement project (UKKW 2026) - "A randominsed controlled trial assessing Vicadrostat (an aldosterone synthase inhibitor) in addition to SGLT2i is enrolling CKD patients regarded as high risk (2)...This study, evaluating finerenone vs placebo, layered on top of standard-of-care (RAS inhibition + Flozin) may open to UK recruitment...(1)Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: reference and alternative scenarios for 2016-40 for 195 countries and territories. 2018."

Clinical • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Infectious Disease • Metabolic Disorders • Nephrology • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

Aldosterone synthase inhibitors in hypertension and chronic kidney disease: double the benefit? (PubMed, Curr Opin Nephrol Hypertens) - "In randomized controlled trials, patients assigned to second generation ASIs had beneficial effects on blood pressure and albuminuria, with enhanced safety profiles. Although long-term clinical outcomes are still under investigation, ASIs have the potential to narrow critical gaps in cardiorenal care."

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

Second-Generation Aldosterone Synthase Inhibitors for Hypertension: A Bayesian Meta-Analysis of Randomized Trials. (PubMed, JACC Adv) - "Second-generation ASIs had a high likelihood of a clinically significant reduction in SBP compared with placebo. However, hyperkalemia, hyponatremia, and hypotension were more frequent with ASIs."

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

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=416 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jan 2027 ➔ Aug 2026 | Trial primary completion date: Jan 2027 ➔ Aug 2026

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

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=416 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Kidney Disease • Nephrology • Renal Disease

1378-0041: A study to test vicadrostat (BI 690517) taken together with empagliflozin in people with type 2 diabetes, high blood pressure, and cardiovascular disease (clinicaltrialsregister.eu) - P2/3 | N=4576 | Recruiting | Sponsor: Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Head-to-Head • New P2/3 trial • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • Type 2 Diabetes Mellitus

Established and emerging pharmacologic options and unmet need in HFpEF and HFmrEF. (PubMed, ESC Heart Fail) - "Finerenone, a non-steroidal mineralocorticoid receptor antagonist, reduced HF events and cardiovascular deaths in participants with HF and EF ≥40% in the FINEARTS-HF trial, and is under evaluation for HFpEF and HFmrEF in the REDEFINE-HF and CONFIRMATION-HF trials. Trials of glucagon-like peptide-1 receptor agonist (GLP-1 RA), semaglutide, and dual glucose-dependent insulinotropic polypeptide receptor agonist/GLP-1 RA, tirzepatide, for HFpEF with obesity, observed an impact on HF hospitalization events and quality of life. Trials of selective mineralocorticoid modulator, balcinrenone, and aldosterone synthase inhibitor, vicadrostat, will address key evidence gaps and help improve outcomes for patients with HFpEF and HFmrEF."

Journal • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Genetic Disorders • Heart Failure • Nephrology • Obesity • Renal Disease

Cumulative Effects of Vicadrostat and Empagliflozin on Albuminuria in CKD. (PubMed, Am J Kidney Dis) - No abstract available

Journal • Chronic Kidney Disease • Nephrology • Renal Disease

A study to test whether BI 690517 in combination with empagliflozin helps people with heart failure (ChiCTR) - P3 | N=6000 | Recruiting | Sponsor: Zhongshan Hospital, Fudan University; Zhongshan Hospital, Fudan University

New P3 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

Transporter-transporter interplay determines the renal-predominant elimination of the O-glucuronide metabolite (BI 689875) of vicadrostat in humans. (PubMed, Drug Metab Dispos) - "Vicadrostat, an aldosterone synthase inhibitor in development in combination with empagliflozin for chronic kidney disease, heart failure, and cardiovascular risk reduction, undergoes extensive hepatic glucuronidation primarily by UDP-glucuronosyltransferase (UGT)2B7 to form BI 689875, an ether glucuronide metabolite. SIGNIFICANCE STATEMENT: BI 689875, a glucuronide metabolite, is formed in the liver but eliminated in urine. Through proteomics-informed in vitro-in vivo extrapolation, hepatic MRP3 and renal OAT3 were identified as key contributors to its predominant urinary elimination, highlighting interorgan transporter interplay."

Journal • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Heart Failure • Nephrology • Renal Disease • ABCC3

Aldosterone synthase inhibitors across the translational spectrum: Mechanistic foundations and emerging clinical applications. (PubMed, J Intern Med) - "Next-generation ASIs-including baxdrostat, lorundrostat, dexfadrostat phosphate, and vicadrostat-demonstrate >100-fold selectivity for CYP11B2 over CYP11B1, enabling potent and reversible aldosterone suppression while maintaining cortisol biosynthesis. Collectively, these findings position ASIs as a selective and mechanistically coherent therapeutic strategy that addresses residual aldosterone activity beyond conventional RAAS blockade. Although current evidence relies largely on surrogate endpoints, ongoing phase III outcome trials will determine whether ASIs can translate mechanistic promise into durable cardiovascular and renal protection, potentially redefining the therapeutic landscape of aldosterone-mediated diseases."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Endocrine Disorders • Fibrosis • Hypertension • Immunology • Nephrology • Renal Disease • CYP11B1

Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS) (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: University Medical Center Groningen

New P2 trial • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Heart Failure • Nephrology • Renal Disease

Pharmacodynamics of vicadrostat for aldosterone synthase inhibition in patients with CKD. (PubMed, Eur J Endocrinol) - P2 | "Vicadrostat, with or without background empagliflozin, selectively suppressed aldosterone over cortisol. These findings will be explored in a phase 3 trial program."

Clinical • Journal • PK/PD data • Chronic Kidney Disease • Nephrology • Renal Disease • CYP11B1

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

Urine Extracellular Vesicle miRNA Changes Induced by Vicadrostat with/Without Empagliflozin in Patients with Chronic Kidney Disease. (PubMed, Int J Mol Sci) - "Vicadrostat plus empagliflozin altered uEV miRNAs involved in immunomodulatory and fibrotic pathways irrespective of participant diabetes status. Regulation of miRNAs may provide insights into synergistic mechanisms of vicadrostat and empagliflozin in CKD treatment."

Journal • Chronic Kidney Disease • Diabetes • Fibrosis • Metabolic Disorders • Nephrology • Renal Disease • MIR192 • MIR194 • MIR199B • MIR27A • MIR381 • MIR513A1

Urine Exosomal miRNA Alterations Induced by Vicadrostat and Empagliflozin in Patients with CKD (KIDNEY WEEK 2025) - P2 | "Conclusion VicaEmpa or VICA alone altered various uEV miRNAs involved in immunomodulatory and fibrotic pathways irrespective of diabetes status. Regulation of miRNAs in the kidney provides insights into mechanisms of action for VICA in CKD."

Clinical • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Fibrosis • Metabolic Disorders • Nephrology • Renal Disease

Selectivity of Vicadrostat for Aldosterone Synthase Inhibition: Findings from a Phase 2 Trial in CKD (KIDNEY WEEK 2025) - P2, P3 | "Conclusion Vicadrostat, with or without empagliflozin, selectively suppressed aldosterone levels, without any meaningful effects on cortisol. These findings will be explored further in EASi-HF Preserved™ (NCT06424288), EASi-HF Reduced™ (NCT06935370) and EASi-Kidney™ (NCT06531824) phase 3 trials."

P2 data • Chronic Kidney Disease

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

EASi-PROTKT Clinical Trail (ChiCTR) - P3 | N=11674 | Not yet recruiting | Sponsor: Peking University Third Hospital; Peking University Third Hospital

Head-to-Head • New P3 trial • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study in Healthy People to Test How 2 Different Formulations of a Combination Treatment (Vicadrostat and Empagliflozin) Are Taken up in the Body and How Food Influences the Amount of the Medicines in the Blood (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion