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Mineralys Therapeutics, Inc. (MLYS)

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.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Mineralys Therapeutics, Inc. logo

Mineralys Therapeutics, Inc.

NASDAQ:MLYSHealthcare
-14.41%$18.18
AH$18.29+0.61%vs close
Mkt Cap$1.61B
Float63.89M
O/S88.41M
Vol
$ Vol
RVOL
Inst Own-
SI11.6%
Earnings
Dilution
Upcoming Catalysts
Phase Distribution
6 lead-sponsored trials·1 active·5 completed
Phase 24
Phase 32

Trials need funding. See this company's dilution risk and cash position.

Recent Deals
  • Tanabe Pharma CorporationLICENSE IN
    / $255M totalOct 27, 2026
    lorundrostat
Clinical Trials
Status
Phase
  • Phase 3
    Active, not recruiting

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

    lorundrostat, Placebo

    Hypertension

    Enrollment
    1,076
    Start
    Jul 2023
    Primary Completion
    Dec 2025
    Completion
    May 2027est.
    NCT05968430
  • Phase 3
    Completed

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

    Placebo, lorundrostat Dose 1

    Hypertension

    Enrollment
    1,083
    Start
    Nov 2023
    Primary Completion
    Dec 2024READOUT • p=0.002
    Completion
    Jan 2025
    NCT06153693
  • Phase 2
    Completed

    Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension

    MLS-101 (Part I), MLS-101 (Part II)

    Hypertension, Renal

    Enrollment
    200
    Start
    Jul 2021
    Primary Completion
    Sep 2022
    Completion
    Oct 2022
    NCT05001945
  • Phase 2
    Completed

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

    Placebo, lorundrostat Dose 1

    Hypertension

    Enrollment
    285
    Start
    Mar 2023
    Primary Completion
    Jan 2025
    Completion
    Jan 2025
    NCT05769608
  • Phase 2
    Completed

    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

    Lorundrostat 25mg+SGLT2i QD, Washout, Placebo+SGLT2i QD, Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QD

    Chronic Kidney Disease

    Enrollment
    60
    Start
    Dec 2023
    Primary Completion
    Feb 2025READOUT • p=0.002
    Completion
    Apr 2025
    NCT06150924
  • Phase 2
    Completed

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

    Lorundrostat, Placebo

    Obstructive Sleep Apnea, Hypertension

    Enrollment
    48
    Start
    Feb 2025
    Primary Completion
    Dec 2025
    Completion
    Dec 2025
    NCT06785454