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Mineralys Therapeutics

Mineralys Therapeutics logo
🇺🇸United States
Ownership
Public
Established
2020-01-01
Employees
28
Market Cap
$606.6M
Website
http://www.mineralystx.com
Introduction

Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which focuses on developing medicines to target diseases driven by abnormally elevated aldosterone. Its clinical-stage product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that are initially developing for the treatment of cardiorenal conditions affected by abnormally elevated aldosterone, including hypertension and chronic kidney disease. The company was founded by Brian Taylor Slingsby on May 31, 2019 and is headquartered in Radnor, PA.

Clinical Trials

9

Active:3
Completed:4

Trial Phases

3 Phases

Phase 1:2
Phase 2:4
Phase 3:3

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (9 trials with phase data)• Click on a phase to view related trials

Phase 2
4 (44.4%)
Phase 3
3 (33.3%)
Phase 1
2 (22.2%)

A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension

Phase 2
Recruiting
Conditions
Obstructive Sleep Apnea
Hypertension
Interventions
Drug: Placebo
First Posted Date
2025-01-21
Last Posted Date
2025-05-15
Lead Sponsor
Mineralys Therapeutics Inc.
Target Recruit Count
40
Registration Number
NCT06785454
Locations
🇺🇸

The University of Alabama, Tuscaloosa, Alabama, United States

🇺🇸

Chandler Clinical Trials, Chandler, Arizona, United States

🇺🇸

Preferred Research Partners Inc., Little Rock, Arkansas, United States

and more 25 locations

Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

Phase 3
Completed
Conditions
Hypertension
Interventions
Drug: lorundrostat Dose 1
Drug: Placebo
Drug: lorundrostat Dose 2
First Posted Date
2023-12-01
Last Posted Date
2025-02-24
Lead Sponsor
Mineralys Therapeutics Inc.
Target Recruit Count
1083
Registration Number
NCT06153693
Locations
🇺🇸

Advanced Cardiovascular, LLC - Alexander City Office, Alexander City, Alabama, United States

🇺🇸

Central Research Associates, Inc, Birmingham, Alabama, United States

🇺🇸

Cardiology, P.C., Birmingham, Alabama, United States

and more 181 locations

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

Phase 2
Completed
Conditions
Chronic Kidney Disease
Interventions
Drug: Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QD
Drug: Lorundrostat 25mg+SGLT2i QD, Washout, Placebo+SGLT2i QD
First Posted Date
2023-11-29
Last Posted Date
2025-07-08
Lead Sponsor
Mineralys Therapeutics Inc.
Target Recruit Count
60
Registration Number
NCT06150924
Locations
🇺🇸

Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thunderbird Office, Glendale, Arizona, United States

🇺🇸

Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thomas Office, Phoenix, Arizona, United States

🇺🇸

Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula Vista, Chula Vista, California, United States

and more 41 locations

Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension

Phase 3
Active, not recruiting
Conditions
Hypertension
Interventions
Drug: Placebo
First Posted Date
2023-08-01
Last Posted Date
2025-06-15
Lead Sponsor
Mineralys Therapeutics Inc.
Target Recruit Count
1400
Registration Number
NCT05968430
Locations
🇺🇸

Accel Research Sites (ARS) - Birmingham Clinical Research Unit, Birmingham, Alabama, United States

🇺🇸

G & L Research LLC, Foley, Alabama, United States

🇺🇸

Chandler Clinical Trials, Chandler, Arizona, United States

and more 170 locations

A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen

Phase 2
Completed
Conditions
Hypertension
Interventions
Drug: lorundrostat Dose 2
Drug: lorundrostat Dose 1
Drug: Placebo
First Posted Date
2023-03-15
Last Posted Date
2025-02-18
Lead Sponsor
Mineralys Therapeutics Inc.
Target Recruit Count
285
Registration Number
NCT05769608
Locations
🇺🇸

Cardiology, P.C. - Birmingham, Birmingham, Alabama, United States

🇺🇸

University of Alabama at Birmingham (UAB) - Vascular Biology and Hypertension Program, Birmingham, Alabama, United States

🇺🇸

Chandler Clinical Trials, Chandler, Arizona, United States

and more 100 locations
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News

Novel Drug Lorundrostat Shows Significant Promise for Uncontrolled Hypertension in Phase 2b Trial

Cleveland Clinic-led clinical trial demonstrates lorundrostat, an aldosterone synthase inhibitor, reduced systolic blood pressure by 8 points more than placebo in patients with uncontrolled hypertension.

Mineralys Therapeutics Secures $175 Million in Public Offering to Advance Aldosterone Inhibitor for Cardiorenal Diseases

Mineralys Therapeutics has priced its public offering at $13.50 per share, raising approximately $175 million to fund the clinical development of lorundrostat, its aldosterone synthase inhibitor.

Mineralys Therapeutics' Lorundrostat Advances to Phase 2 for Obstructive Sleep Apnea and Hypertension

Mineralys Therapeutics' lorundrostat receives FDA clearance for a Phase 2 trial targeting obstructive sleep apnea (OSA) in hypertensive patients.

Mineralys Therapeutics Completes Enrollment in Lorundrostat Hypertension Trials, Anticipates 2025 Data

• Mineralys Therapeutics completed enrollment in the pivotal Advance-HTN trial for uncontrolled or resistant hypertension, with topline data expected in March 2025. • The company also completed enrollment ahead of schedule in the Phase 3 Launch-HTN trial, anticipating topline data in the first half of 2025. • Enrollment is ongoing in the Explore-CKD Phase 2 trial, which is evaluating lorundrostat in patients with hypertension and Stage 2 to 3b chronic kidney disease, with topline data expected in Q2 2025.

Mineralys Therapeutics Completes Enrollment in Lorundrostat Phase 3 Hypertension Trial Ahead of Schedule

• Mineralys Therapeutics completed enrollment in the Launch-HTN trial, a Phase 3 study evaluating lorundrostat for uncontrolled or resistant hypertension, ahead of schedule. • The Launch-HTN trial is a randomized, double-blinded, placebo-controlled study assessing the efficacy and safety of lorundrostat in adult participants on multiple antihypertensive medications. • Topline data from the Launch-HTN trial, which models real-world treatment in the primary care setting, is now expected in mid first half of 2025. • Lorundrostat is a selective aldosterone synthase inhibitor being developed for hypertension and chronic kidney disease, targeting dysregulated aldosterone levels.

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