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

Breaking down resistance: novel aldosterone synthase inhibitors in the management of resistant hypertension. (PubMed, J Hypertens) - "The review highlights clinical trial evidence to-date for all agents in this class, with a key focus on the two most mature agents baxdrostat and lorundrostat which are currently in pivotal Phase 3 trials. They have also shown promise with marked blood pressure reductions in patients with varying physiological profiles and few adverse events at optimised doses. However, as would be expected, both drugs are associated with increases in serum potassium levels, necessitating careful monitoring."

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

Prediction of pharmacokinetic/pharmacodynamic properties of aldosterone synthase inhibitors at drug discovery stage using an artificial intelligence-physiologically based pharmacokinetic model. (PubMed, Front Pharmacol) - "Following calibration and validation using published data, the model was applied to estimate the PK parameters of Baxdrostat, Dexfadrostat, Lorundrostat, BI689648, and the 11β-hydroxylase inhibitor LCI699. The results demonstrated that the PK/PD properties of an ASI could be inferred from its structural formula within a certain error range, providing a reference for early ASI lead compounds screening and optimization. Further validation and refinement of this model will enhance its predictive accuracy and expand its application in drug discovery."

Journal • PK/PD data

A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Mineralys Therapeutics Inc. | Not yet recruiting ➔ Recruiting

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

Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension (clinicaltrials.gov) - P3 | N=1400 | Active, not recruiting | Sponsor: Mineralys Therapeutics Inc. | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Hypertension

Lorundrostat Efficacy and Safety in Patients with Uncontrolled Hypertension. (PubMed, N Engl J Med) - P2 | "Lorundrostat was associated with greater reductions in 24-hour average blood pressure than placebo in participants with uncontrolled and treatment-resistant hypertension. (Funded by Mineralys Therapeutics; Advance-HTN ClinicalTrials.gov number, NCT05769608.)."

Journal • Cardiovascular • Hypertension

Mineralys Therapeutics Announces Publication of Pivotal Phase 2 Advance-HTN Results in the New England Journal of Medicine (NEJM) (GlobeNewswire) - P2 | N=285 | Advance-HTN (NCT05769608) | Sponsor: Mineralys Therapeutics Inc. | "Mineralys Therapeutics...today announced that the New England Journal of Medicine (NEJM) published the detailed results from the Company’s pivotal Phase 2 Advance-HTN trial, the first of two pivotal trials evaluating lorundrostat in patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN)....The key data from the publication showed that lorundrostat 50 mg demonstrated a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction (p=0.001), in 24-hour ambulatory blood pressure at week 12."

P2 data • Hypertension

Efficacy Of Lorundrostat, A Novel Aldosterone Synthase Inhibitor, In Patients With Uncontrolled Hypertension On A Standardized Antihypertensive Medication Regimen - Luke Laffin (ACC 2025) - No abstract available

Clinical • Late-breaking abstract • Cardiovascular • Hypertension

Efficacy Of Lorundrostat, A Novel Aldosterone Synthase Inhibitor, In Patients With Uncontrolled Hypertension On A Standardized Antihypertensive Medication Regimen - Luke Laffin (ACC 2025) - No abstract available

Clinical • Late-breaking abstract • Cardiovascular • Hypertension

Mineralys Therapeutics Announces Late-Breaking Data from Advance-HTN Pivotal Trial of Lorundrostat in Uncontrolled and Resistant Hypertension Presented at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.25) (GlobeNewswire) - P2 | N=285 | Advance-HTN (NCT05769608) | Sponsor: Mineralys Therapeutics Inc. | "Mineralys Therapeutics...today announced detailed results from the Phase 2 Advance-HTN trial, one of two pivotal trials evaluating lorundrostat in patients with confirmed uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). In the trial, lorundrostat 50 mg demonstrated a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction at week 12. Additionally, lorundrostat demonstrated a favorable safety and tolerability profile, with modest changes in potassium, sodium and eGFR, and a low discontinuation rate....SAEs occurred in 6%, 8% and 2% of patients in the lorundrostat 50 mg, lorundrostat 50 to 100 mg and placebo arms, respectively; Treatment-related SAEs occurred in 2%, 1% and 0% of patients in the lorundrostat 50 mg, lorundrostat 50 to 100 mg and placebo arms, respectively."

Late-breaking abstract • P2 data • Hypertension

Mineralys Therapeutics to Host KOL Call to Discuss Clinical Data from Launch-HTN and Advance-HTN Pivotal Trials Tuesday, April 1, 2025, at 8:00 AM ET (GlobeNewswire) - "Mineralys Therapeutics, Inc...announced it will host a conference call and webinar featuring Dr. Luke Laffin of the Cleveland Clinic, who will discuss the latest results from the pivotal Advance-HTN and Launch-HTN clinical trials, and offer his perspective on the unmet medical need in uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), and the potential of lorundsrostat to change the current treatment paradigm."

P2 data • P3 data • Hypertension

Mineralys Therapeutics Announces Closing of Underwriters’ Option to Purchase Additional Shares in Connection with Public Offering of Common Stock (GlobeNewswire) - "Mineralys intends to use the net proceeds from the offering to fund clinical development of lorundrostat, including research and development and manufacturing, and pre-commercialization activities, as well as for working capital and general corporate purposes."

Commercial • Chronic Kidney Disease • Hypertension

Mineralys Therapeutics Announces Data from the Phase 2 Advance-HTN Trial of Lorundrostat for the Treatment of Hypertension Has Been Accepted as a Late-Breaking Presentation at the 2025 American College of Cardiology’s Annual Scientific Session & Expo (GlobeNewswire) - "Mineralys Therapeutics, Inc...today announced that data from the Phase 2 Advance-HTN trial evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) will be presented in a late-breaking clinical trials session at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.25), which is being held in Chicago on March 29-31, 2025."

P2 data • Hypertension

Mineralys Therapeutics Announces Proposed Public Offering of Common Stock (GlobeNewswire) - "Mineralys Therapeutics...announced today that it has commenced an underwritten public offering of $250.0 million of shares of its common stock. In addition, Mineralys expects to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of shares of its common stock at the public offering price, less the underwriting discounts and commissions....Mineralys intends to use the net proceeds from the proposed offering to fund clinical development of lorundrostat, including research and development and manufacturing, and pre-commercialization activities, as well as for working capital and general corporate purposes."

Commercial • Hypertension • Obstructive Sleep Apnea

Mineralys Therapeutics Announces Positive Topline Results from Launch-HTN…Trials of Lorundrostat for the Treatment of Uncontrolled or Resistant Hypertension (GlobeNewswire) - P3 | N=1083 | Launch-HTN (NCT06153693) | Sponsor: Mineralys Therapeutics Inc. | "The trial met its endpoints demonstrating clinically meaningful, statistically significant mean reduction from baseline in placebo-adjusted systolic blood pressure at week six and the benefit was sustained with potential further reduction through week 12...The change in blood pressure in response to lorundrostat in subjects using two background antihypertensives (uncontrolled) or three to five (resistant) were similar, and both were statistically significantly different from the response in those taking placebo."

P3 data: top line • Hypertension

Mineralys Therapeutics Announces Positive Topline Results from…Advance-HTN Pivotal Trials of Lorundrostat for the Treatment of Uncontrolled or Resistant Hypertension (GlobeNewswire) - P2 | N=285 | Advance-HTN (NCT05769608) | Sponsor: Mineralys Therapeutics Inc. | "The trial met its primary endpoint, with placebo-adjusted reduction from baseline in systolic blood pressure assessed with 24-hour average blood pressure measurement at week 12 of -7.9 mmHg in subjects treated with 50 mg of lorundrostat. Other prespecified outcome measures, including measures of efficacy in the dose-escalation cohort, safety and tolerability, were consistent with those observed in the Launch-HTN trial."

P2 data • Hypertension

Mineralys Therapeutics to Announce Topline Data from Launch-HTN and Advance-HTN Pivotal Trials Monday, March 10, 2025, at 8:00 AM ET (GlobeNewswire) - "Mineralys Therapeutics...announced it will host a conference call and webinar to announce topline results from its Launch-HTN and Advance-HTN pivotal trials on Monday, March 10, 2025, at 8:00 a.m. ET. The Launch-HTN trial evaluated the efficacy and safety of lorundrostat, a highly selective aldosterone inhibitor, for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) as an add-on therapy to an existing, prescribed background treatment of two to five antihypertensive medications. The Advance-HTN trial evaluated the efficacy and safety of lorundrostat for the treatment of uHTN or rHTN when used as an add-on therapy to a standardized background treatment of two or three anti-hypertensive medications."

P2 data • P3 data: top line • Hypertension

Targeting aldosterone to improve cardiorenal outcomes: from nonsteroidal mineralocorticoid receptor antagonists to aldosterone synthase inhibitors. (PubMed, Curr Opin Nephrol Hypertens) - "In the coming years, nonsteroidal MR antagonists and aldosterone synthase inhibitors are likely to play an increasingly large role in routine medical practice to help improve cardiovascular and kidney outcomes."

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

Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension (clinicaltrials.gov) - P3 | N=1083 | Completed | Sponsor: Mineralys Therapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension

Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Subjects with Hypertension and Chronic Kidney Disease (CKD) with Albuminuria (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Mineralys Therapeutics Inc. | Recruiting ➔ Active, not recruiting

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

A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen (clinicaltrials.gov) - P2 | N=285 | Completed | Sponsor: Mineralys Therapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension

Mineralys Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Pivotal Advance-HTN Trial – Anticipate reporting topline data in March 2025...Pivotal Launch-HTN Phase 3 Trial – Anticipate reporting topline data in mid first half of 2025...Explore-CKD Phase 2 Trial – Enrollment completed and topline data is anticipated in the second quarter of 2025...Explore-OSA Phase 2 Trial – Initiation planned in the first quarter of 2025."

P2 data • P3 data: top line • Trial status • Chronic Kidney Disease • Hypertension • Obstructive Sleep Apnea

Mineralys Therapeutics Completes Enrollment in Explore-CKD Phase 2 Trial of Lorundrostat for the Treatment of Hypertension in Subjects with Stage 2 to 3b CKD and Albuminuria (GlobeNewswire) - "Mineralys Therapeutics...today announced that it has completed enrollment in the Explore-CKD Phase 2 trial evaluating the efficacy and safety of lorundrostat for the treatment of hypertension in subjects with CKD and albuminuria, despite receiving stable treatment with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) and an SGLT2 inhibitor...'We are pleased to have completed enrollment in Explore-CKD and be on track to share topline data in the second quarter of 2025.'....The Explore-CKD trial (NCT06150924) is a randomized, double-blind, placebo controlled, two-period, two-sequence (2x2) crossover trial. This proof-of-concept trial is designed to evaluate blood pressure reduction and safety of 25 mg once daily (QD) lorundrostat added to RAAS inhibition and an SGLT2 inhibitor for the treatment of hypertension in subjects with Stage 2 to 3b CKD and albuminuria."

Enrollment closed • P2 data • Chronic Kidney Disease • Hypertension

A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Mineralys Therapeutics Inc.

New P2 trial • Cardiovascular • Hypertension • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Mineralys Therapeutics Announces Phase 2 Clinical Trial of Lorundrostat for Obstructive Sleep Apnea in Patients with Hypertension (GlobeNewswire) - "Mineralys Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) Application for a Phase 2 clinical trial to evaluate the effect of lorundrostat in the treatment of subjects with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. The Company anticipates initiating the trial in the first quarter of 2025."

IND • New P2 trial • Hypertension • Obstructive Sleep Apnea

Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Subjects with Hypertension and Chronic Kidney Disease (CKD) with Albuminuria (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Mineralys Therapeutics Inc. | Trial completion date: Jan 2025 ➔ May 2025 | Trial primary completion date: Oct 2024 ➔ Feb 2025

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