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

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

Aldosterone Synthase Inhibitors Effectively Lower Blood Pressure but Increase Hyperkalemia Risk: A Meta-Analysis of Randomized Trials (AHA 2025) - "The increased risk of hyperkalemia—particularly with lorundrostat—warrants monitoring. These agents may hold promise for enhanced efficacy when combined with other antihypertensive therapies in future trials."

Retrospective data • Heart Failure • Hypertension • Hypotension

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

Advance-HTN Trial Participant Characteristics Associated with a Failure to be Randomized (AHA 2025) - "The Advance-HTN trial demonstrated the BP lowering efficacy of lorundrostat compared with placebo. In contrast, use of indapamide in the standardized AHT regimen was associated with greater odds of failing to be randomized (OR: 1.39, 95% CI: 1.03-1.87, p = 0.03).ConclusionAdvance-HTN participant characteristics associated with a failure to be randomized were identified. These data may inform future hypertension trial design including participant selection strategies to maximize enrollment of patients with true uncontrolled hypertension"

Clinical • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders

Lorundrostat for Uncontrolled Hypertension and Treatment-Resistant Hypertension-Reply. (PubMed, JAMA) - No abstract available

Journal • Cardiovascular • Hypertension

Lorundrostat for Uncontrolled Hypertension and Treatment-Resistant Hypertension. (PubMed, JAMA) - No abstract available

Journal • Cardiovascular • Hypertension

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

Enrollment closed • Cardiovascular • Hypertension • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Efficacy and Safety of Lorundrostat in Uncontrolled and/or Treatment Resistant Hypertension: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, High Blood Press Cardiovasc Prev) - "Lorundrostat effectively reduces systolic BP in uncontrolled and resistant hypertension but requires cautious monitoring due to safety concerns."

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

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

Efficacy and safety of lorundrostat in patients with uncontrolled or resistant hypertension: A systematic review and meta-analysis with trial sequential analysis. (PubMed, Vascul Pharmacol) - "Lorundrostat effectively controls blood pressure in patients with uncontrolled hypertension; however, it also increases the incidence of adverse events, and further large-scale trials are needed to confirm long-term efficacy and safety."

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

Efficacy and Safety of Lorundrostat in Patients With Uncontrolled and Treatment-Resistant Hypertension: A Systematic Review and Meta-Analysis. (PubMed, Cureus) - "This magnitude of blood pressure reduction is clinically meaningful and comparable to established fourth-line therapies like spironolactone. These findings suggest that lorundrostat represents a promising therapeutic option for treatment-resistant hypertension, offering clinically significant blood pressure reductions with an acceptable safety profile. However, long-term cardiovascular outcome studies and direct comparisons with existing therapies are needed to fully establish its clinical role."

Journal • Retrospective data • Review • Cardiovascular • Hypertension

Efficacy and Safety of Lorundrostat in Uncontrolled Hypertension: A Systematic Review and Meta-Analysis. (PubMed, J Clin Hypertens (Greenwich)) - "Hyperkalemia and hyponatremia remain notable risks. Further long-term trials are warranted to validate its sustained efficacy and safety."

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

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

Targeting unmet clinical need with a novel aldosterone synthase inhibitor lorundrostat (ESC-WCC 2025) - "Sponsored by Mineralys"

Clinical • Cardiovascular • Hypertension

Targeting dysregulated aldosterone in uncontrolled and treatment resistant hypertension with a novel aldosterone synthase inhibitor, lorundrostat (ESC-WCC 2025) - "Sponsored by Mineralys Review the clinical unmet need in uncontrolled and treatment resistant hypertension Review the spectrum of dysregulated aldosterone and its role in hypertension Review aldosterone synthase inhibition (ASI), including lorundrostat, a novel ASI, for the treatment of uncontrolled hypertension, including treatment-resistant hypertension"

Cardiovascular • Hypertension

Aldosterone Synthase Inhibitors for Resistant Hypertension: Pharmacological Insights - A Systematic Review. (PubMed, Drugs) - "Emerging data support the potential of ASIs as a therapeutic option for RHT, particularly when treatment is individualized based on renal function, dietary sodium intake, and comorbidities. Personalized treatment strategies may enhance efficacy, improve tolerability, and support durable blood pressure control in this difficult-to-treat population."

Journal • Review • Cardiovascular • Endocrine Disorders • Hypertension

Lorundrostat Efficacy and Safety in Uncontrolled Hypertension. (PubMed, N Engl J Med) - No abstract available

Journal • Cardiovascular • Hypertension