lorundrostat (MT-4129) / Mineralys Therap - LARVOL DELTA

Aldosterone synthase inhibition in hypertension: an evolving therapeutic strategy. (PubMed, Curr Opin Cardiol) - "Aldosterone synthase inhibition represents an advance in hypertension therapeutics. If ongoing and future outcome-driven trials confirm cardiovascular and renal benefit, ASIs may reshape treatment algorithms, complement existing renin-angiotensin-aldosterone-based strategies, and enable more precise targeting of aldosterone-mediated disease."

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

EFFICACY AND SAFETY OF LORUNDROSTAT IN THE MANAGEMENT OF HYPERTENSION: A SYSTEMATIC REVIEW AND META-ANALYSIS (ACC 2026) - "Lorundrostat 50 mg daily demonstrates significant antihypertensive efficacy but is associated with higher risks of hyperkalemia and symptomatic hypotension. Careful monitoring is warranted to balance its therapeutic benefits against potential safety concerns."

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

SELECTIVE ALDOSTERONE SYNTHASE INHIBITORS IN UNCONTROLLED AND RESISTANT HYPERTENSION: AN UPDATED META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS (ACC 2026) - " We systematically searched PubMed, Embase and Cochrane for randomized controlled trials (RCTs) comparing selective ASIs (Lorundrostat, Baxdrostat) vs placebo in patients with uncontrolled or resistant hypertension. Selective ASIs provide clinically meaningful reductions in BP for patients with uncontrolled or resistant hypertension, but are associated with increased risk of hyperkalemia, hyponatremia and hypotension, warranting careful patient selection and monitoring."

Retrospective data • Cardiovascular • Heart Failure • Hypertension • Hypotension

LORUNDROSTAT FOR UNCONTROLLED HYPERTENSION: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS (ACC 2026) - "Lorundrostat significantly decreased both SBP and DBP at 50mg and 100mg doses, with an increase hyperkalemia risk with both dosages."

Retrospective data • Review • Cardiovascular • Hypertension

ALDOSTERONE SYNTHASE INHIBITORS FOR RESISTANT OR UNCONTROLLED HYPERTENSION: A NETWORK META-ANALYSIS OF RANDOMIZED CLINICAL TRIALS (ACC 2026) - "Baxdrostat, Lorundrostat, and Osilodrostat significantly reduced SBP (Baxdrostat: MD −8.81, 95% CI −10.94 to −6.67; Lorundrostat: MD −8.42, 95% CI −11.05 to −5.78; Osilodrostat: MD −6.78, 95% CI −9.64 to −3.92) and DBP (Baxdrostat: MD −3.14, 95% CI −5.24 to −1.03; Lorundrostat: MD −3.23, 95% CI −5.32 to −1.13; Osilodrostat: MD −2.58, 95% CI −5.13 to −0.02). ASIs significantly lowered SBP and DBP in patients with resistant hypertension without increasing the risk of serious adverse events. These findings suggest ASIs may represent a promising therapeutic option for resistant hypertension."

Retrospective data • Cardiovascular • Hypertension

LORUNDROSTAT EFFICACY AND SAFETY IN PATIENTS WITH UNCONTROLLED HYPERTENSION: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS (ACC 2026) - "In our meta-analysis, Lorundrostat improved blood pressure control in uncontrolled HTN but increased the risk of adverse events."

Retrospective data • Review • Cardiovascular • Hypertension • Hypotension

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

Mineralys Therapeutics, Inc….announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs. (GlobeNewswire) - "The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026."

FDA filing • PDUFA • Hypertension

Aldosterone synthase inhibitors for resistant or uncontrolled hypertension: a network meta-analysis of randomized clinical trials. (PubMed, J Hypertens) - "Highly selective ASIs (Baxdrostat and Lorundrostat) significantly lowered BP in patients with resistant hypertension without increasing the risk of serious adverse events, whereas the nonselective agent Osilodrostat did not reach the significant difference. These findings suggest that selective aldosterone synthase inhibition represents a promising therapeutic option for resistant hypertension."

Clinical • Journal • Retrospective data • Cardiovascular • Hypertension

New pharmacological therapies for hypertension. (PubMed, Curr Opin Nephrol Hypertens) - "Novel therapies (Zilebesiran, lorundrostat, baxdrostat) have shown great potential in lowering BP that is clinically meaningful to help improve cardiovascular and renal outcomes. ASI therapies lorundrostat and baxdrostat are close to being licensed for HTN. Once commercially available and recommended in treatment guidelines, the next big challenge will be reimbursement and implementation model in different healthcare systems."

Journal • Cardiovascular • Hypertension • Hypotension

A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension (clinicaltrials.gov) - P2 | N=48 | Completed | Sponsor: Mineralys Therapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

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

Lorundrostat for Patients with Uncontrolled Hypertension: A Systematic Review with Meta-Analysis and Trial Sequential Analysis. (PubMed, Am J Hypertens) - "Lorundrostat effectively lowered blood pressure but increased dose-dependent risk of hyperkalemia. These findings support its potential as a novel therapy for uncontrolled hypertension, while emphasizing the need for longer-term cardiovascular outcome trials and direct comparisons with mineralocorticoid receptor antagonists concerning efficacy and safety."

Journal • Retrospective data • Cardiovascular • Hypertension

Targeting aldosterone in sleep apnea: opening a New Therapeutic Era. (PubMed, Expert Opin Investig Drugs) - No abstract available

Journal • Cardiovascular • Hypertension • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Efficacy and safety of lorundrostat in uncontrolled hypertension: A GRADE-assessed systematic review and meta-analysis of randomized controlled trials. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "However, its use is associated with a higher incidence of mild adverse events, hyperkalemia, and hyponatremia. Larger and longer-term trials are warranted to further clarify the role of lorundrostat in hypertension management and to better define its safety profile."

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

Efficacy and safety of lorundrostat in uncontrolled hypertension: a meta-analysis. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "The reduced risk of adrenal insufficiency highlights its selectivity and potential as a valuable therapeutic option. Further large-scale, long-term studies are needed to confirm its sustained benefits and safety."

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

HT.01: Dysregulated Aldosterone in Uncontrolled Hypertension: The Overlooked Risk Factor and New Therapeutic Options. (AHA 2025) - "Aldosterone synthase inhibition with lorundrostat in the Launch-HTN and Explore-CKD trials will be presented. Sponsored By: Mineralys Therapeutics - This is not a CE accredited session."

Clinical • Cardiovascular • Chronic Kidney Disease • Hypertension

Lorundrostat, a Novel Aldosterone Synthase Inhibitor (ASI), in Participants with Uncontrolled Hypertension, CKD, and Albuminuria: Results from Explore-CKD (KIDNEY WEEK 2025) - P2 | "Conclusion Lorundrostat was effective in reducing AOSBP and albuminuria in CKD participants with concurrent uHTN receiving SGLT2i. This parallel reduction is anticipated to provide meaningful benefits in improving CKD-associated cardio-renal outcomes."

Late-breaking abstract • Acute Kidney Injury • Cardiovascular • Chronic Kidney Disease • Diabetes • Hypertension • Metabolic Disorders • Nephrology • Renal Disease • Retinal Disorders • CST3

JAMA: Lorundrostat in Participants with Uncontrolled Hypertension and Treatment-Resistant Hypertension - The Launch-HTN Randomized Clinical Trial (KIDNEY WEEK 2025) - "Funding ASN thanks JAMA and NEJM for assistance with this session."

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

Insights Into Aldosterone Regulation Through Pharmacokinetic-Pharmacodynamic Modeling of an Aldosterone Synthase Inhibitor. (PubMed, Clin Pharmacol Ther) - "In serial stages, we developed a semi-mechanistic pharmacokinetic-pharmacodynamic (PK-PD) model to characterize aldosterone dynamics under conditions of circadian production and inhibition by lorundrostat, a selective aldosterone synthase inhibitor...Sensitivity analysis supported the determinants of aldosterone dynamics in the model. This model provides a systems-level framework to disentangle physiological and pharmacological drivers of aldosterone regulation, supports trial design for aldosterone synthase inhibitors, and may inform the development of more complex models for RAAS control of renal and cardiovascular function."

Journal • PK/PD data • Cardiovascular • Nephrology

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

Journal • Cardiovascular • Endocrine Disorders • Hypertension