vicadrostat (BI 690517) / Boehringer Ingelheim - LARVOL DELTA

Plain language summary of a publication: the effects of vicadrostat given with or without empagliflozin for treatment of chronic kidney disease. (PubMed, Sage Open Chronic Dis) - "Where can I find more information on CKD? National Institute of Diabetes and Digestive and Kidney Diseases (US): https://www.niddk.nih.gov/health-information/kidney-disease/chronic-kidney-disease-ckd National Institute of Diabetes and Digestive and Kidney Diseases (US; Spanish language): https://www.kidney.org/es/kidney-topics/pruebas-para-revisar-la-salud-renal National Kidney Foundation (US): https://www.kidney.org/kidney-topics/chronic-kidney-disease-ckd Kidney Care (UK): https://kidneycareuk.org/kidney-disease-information/kidney-conditions/ckd-chronic-kidney-disease/."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Diabetes • Hypertension • Metabolic Disorders • Nephrology • Renal Disease

EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) (clinicaltrials.gov) - P3 | N=11000 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2028 ➔ Dec 2026 | Trial primary completion date: Aug 2028 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Congestive Heart Failure • Nephrology • Renal Disease

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

A Study in Healthy People to Test How Vicadrostat Affects the Heart (clinicaltrials.gov) - P1 | N=45 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=492 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Nephrology • Renal Disease

Efficacy and safety of selective aldosterone synthase inhibitors for blood pressure reduction in patients with CKD: a meta-analysis of randomized controlled trials. (PubMed, J Hypertens) - "Five RCTs (1,148 patients) were included; 2 used baxdrostat, 2 lorundrostat, and 1 study used vicadrostat. The risk of hyperkalemia was higher with ASIs, but with high heterogeneity (risk ratio, 4.04 [95% CI 0.94 to 17.35], I2 = 76%). In conclusion, selective ASIs present a potential treatment option for BP control and albuminuria reduction in patients with CKD."

Journal • Retrospective data • Acute Kidney Injury • Cardiovascular • Chronic Kidney Disease • Hypertension • 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 (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart (clinicaltrials.gov) - P3 | N=4200 | Recruiting | Sponsor: Boehringer Ingelheim

Head-to-Head • Trial initiation date • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB

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

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

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

A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart (clinicaltrials.gov) - P3 | N=4200 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study to Test Whether BI 690517 in Combination With Empagliflozin Helps People With Heart Failure (clinicaltrials.gov) - P3 | N=6000 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Head-to-Head • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study to Test Whether BI 690517 in Combination With Empagliflozin Helps People With Heart Failure (clinicaltrials.gov) - P3 | N=6000 | Not yet recruiting | Sponsor: Boehringer Ingelheim

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

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 | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease (clinicaltrials.gov) - P3 | N=11800 | Not yet recruiting | Sponsor: Boehringer Ingelheim

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

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure (clinicaltrials.gov) - P3 | N=6000 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Nov 2027 ➔ May 2028 | Trial primary completion date: Nov 2027 ➔ May 2028

Head-to-Head • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart (clinicaltrials.gov) - P3 | N=4200 | Not yet recruiting | Sponsor: Boehringer Ingelheim

Head-to-Head • New P3 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease (clinicaltrials.gov) - P3 | N=11800 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • Cardiovascular • Congestive Heart Failure • Diabetes • Hypertension • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=492 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • 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 | Recruiting | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Recruiting

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

New Drugs on the Horizon for Hypertension. (PubMed, Adv Kidney Dis Health) - "This includes the nonselective endothelin receptor antagonist aprocitentan, which was Food and Drug Administration approved in 2024 for uncontrolled hypertension. Aldosterone synthase inhibitors including baxdrostat, lorundrostat, and vicadrostat are in phase 1 or 2 trials for hypertension or chronic kidney disease with evidence of significant blood pressure lowering. Finally, the novel small-interfering RNA-based zilebesiran targeting angiotensinogen represents a new class of antihypertensive medications with durable blood pressure-lowering dosing only every 3 or 6 months. Each of these medications has unique properties that can potentially contribute to improvement in blood pressure control for individual patients and at the population level. Development of these novel antihypertensives promises a welcome set of new options for the treatment of hypertension."

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

A Study in Healthy People to Test How Vicadrostat Affects the Heart (clinicaltrials.gov) - P1 | N=45 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed

Post-Hoc Analysis on the Effects of Vicadrostat/Empagliflozin by CKD Severity/Hypertension Status. (PubMed, Kidney Int Rep) - P2 | "UACR reductions were consistent in participants irrespective of KDIGO risk group, KFRE subgroup, presence or absence of uncontrolled HTN at baseline or diuretic use. The effects of vicadrostat on albuminuria reduction, with or without empagliflozin, were generally consistent irrespective of CKD stage and kidney risk as scored using KDIGO or the KFRE, HTN status, or use of diuretics."

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

Efficacy and safety of selective aldosterone synthase inhibitors for blood pressure reduction in CKD patients: a systematic review and meta-analysis (ERA 2026) - "Results Five RCTs involving 1,148 patients were included in the analysis for the primary outcome; 2 used baxdrostat, 2 lorundrostat and 1 study used vicadrostat. Image Figure 1. Pooled analyses for the placebo-adjusted SBP change."

Retrospective data • Review • Cardiovascular • Chronic Kidney Disease • Hypertension

Aldosterone synthase inhibitors: a new option for antihypertensive, cardio-renal protection. (PubMed, Hypertens Res) - "In recent years, research into selective aldosterone synthase inhibitors has progressed, resulting in the development of drugs such as baxdrostat, lorundrostat, and vicadrostat. In non-epithelial tissues, aldosterone actions are not major, and ASIs do not affect the physiological actions of cortisol via MR. Further investigation is needed to determine the pharmacological effects of this mechanism, and how it differs from MR antagonists (The recruitment of co-activators and co-repressors in transcriptional activity is omitted)."

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