A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Crossover Study to Evaluate the Efficacy and Safety of Lorundrostat in Participants With Moderate to Severe Obstructive Sleep Apnea and Hypertension

The primary purpose of the study is to assess the effect of lorundrostat taken orally (po) once a day on the Apnea-Hypopnea Index (AHI) in participants with moderate to severe obstructive sleep apnea (OSA) and hypertension.

Start Date28 Feb 2025

Sponsor / Collaborator

Mineralys Therapeutics, Inc.

NCT06150924

/ Active, not recruitingPhase 2

A Randomized, Crossover, Double Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors, in Adults with Hypertension and Chronic Kidney Disease with Albuminuria

This is a randomized, double-blind (DB), placebo controlled, crossover study with a two-period, two-sequence (2x2) design evaluating the efficacy and safety of 25 mg QD lorundrostat (an aldosterone synthase inhibitor [ASI]) in addition to a SGLT2i for the treatment of hypertension in subjects with CKD and albuminuria while receiving stable treatment with an Angiotensin-converting enzyme inhibitor (ACEi) or an Angiotensin receptor blocker (ARB). Subjects will be at least 18 years old with hypertension, and mild to severe CKD with albuminuria at the Screening Visit.

Start Date14 Dec 2023

Sponsor / Collaborator

Mineralys Therapeutics, Inc.

NCT06153693

/ CompletedPhase 3

A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

Start Date22 Nov 2023

Sponsor / Collaborator

Mineralys Therapeutics, Inc.

100 Clinical Results associated with Lorundrostat

100 Translational Medicine associated with Lorundrostat

100 Patents (Medical) associated with Lorundrostat

Literatures (Medical) associated with Lorundrostat

08 May 2025·NEW ENGLAND JOURNAL OF MEDICINE

Lorundrostat Efficacy and Safety in Patients with Uncontrolled Hypertension

Article

Author: Wilkinson, Michael J. ; Ibbitson, Jessica ; Laffin, Luke J. ; Kopjar, Branko ; Nissen, Steven E. ; Ofili, Elizabeth O. ; Rodman, David ; Flack, John M. ; Wolski, Kathy ; Mehra, Reena ; Cohen, Debbie L. ; Melgaard, Carrie ; Sarraju, Ashish ; Bhikam, Shivani ; Luther, James M. ; Weir, Matthew R.

BACKGROUND:

Aldosterone dysregulation contributes to hypertension. Lorundrostat is an aldosterone synthase inhibitor, but data on its efficacy and safety in patients with hypertension are limited.

METHODS:

In this multicenter, double-blind, randomized, placebo-controlled trial, we assigned participants who were receiving two to five antihypertensive medications and had a blood-pressure measurement of 140/90 mm Hg or higher obtained during an office visit to undergo a standardized antihypertensive regimen for 3 weeks. Subsequently, participants with an average 24-hour ambulatory blood pressure of 130/80 mm Hg or higher were assigned to receive placebo, lorundrostat at a stable dose of 50 mg daily (the stable-dose group), or lorundrostat at a starting dose of 50 mg daily, with an increase to 100 mg daily if systolic blood pressure was 130 mm Hg or higher after 4 weeks (the dose-adjustment group). The primary end point was the change in 24-hour average systolic blood pressure from baseline to week 12, assessed as the least-squares mean difference from placebo (the placebo-adjusted change) in each lorundrostat group. A key secondary end point was the change in 24-hour average systolic blood pressure from baseline to week 4, assessed as the placebo-adjusted change in the combined lorundrostat groups.

RESULTS:

A total of 285 participants underwent randomization; 94 were assigned to the stable-dose group, 96 to the dose-adjustment group, and 95 to the placebo group. The mean age was 60 years, and 150 participants (53%) were Black. After 12 weeks, the least-squares mean change in 24-hour average systolic blood pressure was -15.4 mm Hg in the stable-dose group, -13.9 mm Hg in the dose-adjustment group, and -7.4 mm Hg in the placebo group. The placebo-adjusted change in blood pressure was -7.9 mm Hg (97.5% confidence interval [CI], -13.3 to -2.6) in the stable-dose group and -6.5 mm Hg (97.5% CI, -11.8 to -1.2) in the dose-adjustment group. The placebo-adjusted change in 24-hour average systolic blood pressure from baseline to week 4 in the combined lorundrostat groups was -5.3 mm Hg (95% CI, -8.4 to -2.3). A potassium level above 6.0 mmol per liter occurred in 5 participants (5%) in the stable-dose group, 7 participants (7%) in the dose-adjustment group, and no participants in the placebo group.

CONCLUSIONS:

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.).

01 May 2025·CURRENT OPINION IN NEPHROLOGY AND HYPERTENSION

Targeting aldosterone to improve cardiorenal outcomes: from nonsteroidal mineralocorticoid receptor antagonists to aldosterone synthase inhibitors

Review

Author: Hundemer, Gregory L. ; Helmeczi, Wryan

Purpose of review:

Aldosterone dysregulation plays a major role in the pathogenesis of hypertension, cardiovascular disease, and kidney disease. Traditionally, steroidal mineralocorticoid receptor (MR) antagonists, namely spironolactone and eplerenone, have been the only available options to target aldosterone. Over recent years, a host of promising novel aldosterone-targeted pharmacologic agents have been developed thereby providing new options to mitigate aldosterone-mediated cardiovascular and kidney disease.

Recent findings:

Recently, a number of nonsteroidal MR antagonists (finerenone, esaxerenone, and ocedurenone) and highly specific aldosterone synthase inhibitors (baxdrostat, lorundrostat, dexfadrostat, and vicadrostat) have been developed. The early clinical data for these novel medications looks promising regarding their efficacy in improving blood pressure control, preventing adverse cardiovascular outcomes, and slowing chronic kidney disease progression. Moreover, they appear to be generally safe and well tolerated.

Summary:

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.

01 Aug 2024·CTS-Clinical and Translational Science

First‐in‐human study evaluating safety, pharmacokinetics, and pharmacodynamics of lorundrostat, a novel and highly selective aldosterone synthase inhibitor

Article

Author: van Iersel, Mattheus (Thijs) ; Rodman, David M. ; Slingsby, B. T. ; Fujii, Aya ; Kawai, Mizue ; Sugimoto‐Kawabata, Kanami ; Djedjos, Stephen ; Ohta, Yoshiyasu ; Hiraga, Yuki ; Tortorici, Michael A. ; Shimizu, Hidetoshi ; Rahman, Sheikh Mohammed Ashfaq ; Ogawa, Kei ; van Lier, Jan Jaap

Abstract:

Dysregulation of the mineralocorticoid hormone aldosterone is an increasingly prevalent cause of hypertension. Aldosterone synthase (CYP11B2) shares 93% homology to 11β‐hydroxylase (CYP11B1), which produces cortisol. Lorundrostat, a highly selective inhibitor of CYP11B2, is a potential safe and effective treatment for aldosterone‐dependent, uncontrolled hypertension, including treatment‐resistant hypertension. Lorundrostat showed highly selective inhibition of CYP11B2 in vitro, with 374‐fold selectivity for CYP11B2 vs. CYP11B1. A first‐in‐human study of single ascending doses ranging from 5 to 800 mg and multiple ascending doses ranging from 40 to 360 mg once daily was conducted in healthy participants. After single‐ and multiple‐dose administration, lorundrostat plasma levels peaked 1–3 h after administration with a t1/2 of 10–12 h. Plasma aldosterone decreased up to 40% with single 100‐mg to 200‐mg doses and up to 70% with single 400 to 800‐mg doses. Plasma aldosterone returned to baseline within 16 h after single 100‐mg doses and multiple once‐daily 120‐mg doses. Lorundrostat demonstrated a favorable safety profile in healthy participants. Dose‐ and exposure‐dependent inhibition of renal tubular sodium reabsorption was observed across a clinically relevant dose range with no suppression of basal or cosyntropin‐stimulated cortisol production and only a modest increase in mean serum potassium.

News (Medical) associated with Lorundrostat

17 Apr 2025

·www.prnewswire.com

TRYVIO/JERAYGO Positioned to Redefine Treatment of Resistant Hypertension | DelveInsight

TRYVIO (aprocitentan) in the US and JERAYGO in Europe present significant market potential as novel therapies for patients with hypertension inadequately controlled by existing treatments. TRYVIO, approved by the FDA in March 2024 and commercially available since October 2024, targets systemic hypertension in adults not adequately controlled on other drugs. LAS VEGAS, April 17, 2025 /PRNewswire/ -- DelveInsight's " TRYVIO/JERAYGO Market Size, Forecast, and Market Insight Report" highlights the details around TRYVIO/JERAYGO, a dual endothelin receptor antagonist. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TRYVIO/JERAYGO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Idorsia Pharmaceuticals' TRYVIO/JERAYGO (aprocitentan) Overview TRYVIO is a once-daily oral medication that acts as a dual endothelin receptor antagonist, blocking the binding of endothelin-1 (ET-1) to both ETA and ETB receptors. This mechanism makes it particularly effective for reducing blood pressure in adults whose hypertension remains uncontrolled with other treatments. TRYVIO also has a low risk of drug-drug interactions. The active ingredient, aprocitentan, is marketed as TRYVIO in the United States, while in the European Union and the UK, it is available under the brand name JERAYGO. Marketing applications are currently under review in Canada and Switzerland. Notably, TRYVIO is the first oral antihypertensive in a new therapeutic class to receive approval in nearly four decades. Learn more about TRYVIO/JERAYGO projected market size for resistant hypertension @ TRYVIO/JERAYGO Market Potential Resistant hypertension is defined as blood pressure that remains above target levels despite the concurrent use of three antihypertensive agents of different classes, ideally including a diuretic, at optimal doses. This condition affects approximately 10-20% of the hypertensive population and is associated with a higher risk of cardiovascular events, stroke, and renal complications. The pathophysiology is often multifactorial, involving factors such as obesity, high salt intake, secondary hypertension causes, and medication nonadherence. Managing resistant hypertension is challenging due to its complex etiology, requiring a more personalized and multidisciplinary approach. The current treatment paradigm includes intensifying lifestyle interventions, ensuring optimal diuretic use, and exploring secondary causes. In recent years, device-based therapies such as renal denervation and baroreceptor activation therapy have emerged as potential options for select patients, although uptake has been cautious due to mixed clinical trial results. Pharmaceutical innovation has been relatively limited, but there is renewed interest in novel drug classes such as aldosterone synthase inhibitors, endothelin receptor antagonists, and dual-acting agents. The future market outlook is positive, driven by an aging global population, increasing prevalence of obesity and diabetes, and heightened awareness of cardiovascular risk. We expect the resistant hypertension market to grow steadily, with significant commercial opportunity for both drug developers and medtech innovators offering targeted, evidence-based solutions. Discover more about the resistant hypertension market in detail @ Resistant Hypertension Market Report Emerging Competitors of TRYVIO/JERAYGO Some of the competing emerging key players include AstraZeneca (Baxdrostat), Mineralys Therapeutics (Lorundrostat), Tenax Therapeutics (TNX-103), and others. In March 2025, Tenax Therapeutics, Inc. announced that the FDA had completed its review of the company's revised Phase 3 development strategy for TNX-103 (oral levosimendan). This included approval of an amendment to expand patient enrollment and enhance the statistical power of the ongoing Phase III LEVEL trial, as well as the protocol for LEVEL-2, Tenax's second registrational Phase III study. The company stated that it now plans to enroll 230 patients in the LEVEL study, boosting the study's statistical power to over 95%. LEVEL-2, a global trial, is expected to launch in 2025. In March 2025, Mineralys Therapeutics, Inc. reported comprehensive results from the Phase II Advance-HTN trial, one of two key studies assessing lorundrostat in patients with confirmed uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). In this trial, the 50 mg dose of lorundrostat achieved an absolute reduction of 15.4 mmHg in blood pressure and a placebo-adjusted reduction of 7.9 mmHg at week 12. The treatment also showed a favorable safety and tolerability profile, with only minor changes observed in potassium, sodium, and eGFR levels, and a low rate of treatment discontinuation. To know more about the number of competing drugs in development, visit @ TRYVIO/JERAYGO Market Positioning Compared to Other Drugs Key Milestones of TRYVIO/JERAYGO In March 2025, Idorsia announced that the US FDA had fully released TRYVIO from its REMS (Risk Evaluation and Mitigation Strategy) requirement. Idorsia is also released from the post-marketing requirement (PMR) to conduct a worldwide descriptive study that collects prospective and retrospective data in women exposed to TRYVIO during pregnancy and/or lactation, as these data are no longer needed. Idorsia no longer has post-marketing requirements for TRYVIO. In January 2025, Medicines and Healthcare Products Regulatory Agency (MHRA) approved JERAYGO to treat hypertension (high blood pressure) in adults whose blood pressure cannot be adequately controlled by at least three other medicines (also known as resistant hypertension), in the UK. In July 2024, Idorsia received approval from the European Commission for JERAYGO for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure control. In March 2024, Idorsia announced that the US Food and Drug Administration (FDA) has approved TRYVIO for the treatment of hypertension in combination with other antihypertensive drugs to lower blood pressure in adult patients who are not adequately controlled on other drugs. The recommended dosage of TRYVIO is 12.5 mg orally once daily, with or without food. It was made commercially available in the US in October 2024. Discover how TRYVIO/JERAYGO is shaping the resistant hypertension treatment landscape @ TRYVIO/JERAYGO Medication TRYVIO/JERAYGO Market Dynamics TRYVIO (also marketed as JERAYGO in select markets) is a promising therapeutic entrant in the treatment landscape for resistant hypertension, representing a novel mechanism of action targeting the aldosterone pathway. As a selective aldosterone synthase inhibitor, TRYVIO addresses a key pathophysiological driver in resistant hypertension—aldosterone excess—offering a more targeted approach compared to traditional mineralocorticoid receptor antagonists (MRAs) like spironolactone or eplerenone. This differentiation positions TRYVIO as an important alternative for patients who are intolerant to MRAs or who do not achieve adequate blood pressure control despite existing therapies. TRYVIO's entry comes at a time when the hypertension market is seeing renewed attention toward personalized, mechanism-based treatments. Early clinical trial data have demonstrated meaningful reductions in systolic blood pressure with a favorable safety and tolerability profile. This has led to increasing interest among specialists in cardiology and nephrology. TRYVIO's potential to be used alongside existing antihypertensive agents without significant drug-drug interactions is a key advantage. However, uptake may be moderated in the short term by p hysician familiarity with MRAs, payer scrutiny on pricing, and the need for broader real-world data to confirm long-term efficacy and safety. From a regulatory standpoint, TRYVIO/JERAYGO has gained approvals in several major markets, including the U.S. and EU, with regulatory filings underway in Asia-Pacific regions. Payers are cautiously optimistic, with reimbursement being granted in many geographies based on unmet needs and pharmacoeconomic models projecting reductions in cardiovascular events and hospitalizations. That said, its premium pricing compared to generics necessitates the generation of robust health economic data to support its value proposition, especially in cost-sensitive healthcare systems. Looking ahead, TRYVIO is well-positioned to capture a substantial share of the resistant hypertension market, particularly as guidelines begin to incorporate newer therapeutic classes. We forecast steady growth driven by expanding physician adoption, increasing diagnosis of resistant hypertension, and potential label expansion into related indications such as heart failure with preserved ejection fraction (HFpEF). Strategic partnerships, post-marketing surveillance, and long-term outcome studies will be critical in shaping TRYVIO's competitive edge and sustaining momentum in a crowded but evolving treatment landscape. Dive deeper to get more insight into TRYVIO/JERAYGO's strengths & weaknesses relative to competitors @ TRYVIO/JERAYGO Market Drug Report Table of Contents Related Reports Resistant Hypertension Pipeline Resistant Hypertension Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key resistant hypertension companies, including Idorsia Ltd, Janssen Biotech, Quantum Genomics SA, CinCor Pharma, Ionis Pharmaceuticals, and Vifor Pharma, among others. Hypertension Market Hypertension Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key hypertension companies such as Mineralys Therapeutics Inc., CinCor Pharma, among others. Hypertension Pipeline Hypertension Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hypertension companies, including Gossamer Bio, Addpharma Inc., Insmed Incorporated, Alnylam Pharmaceuticals, 35Pharma Inc, Pfizer, Pharmosa Biopharm Inc., Guangzhou Magpie Pharmaceuticals Co., Ltd., Suzhou Sanegene Bio Inc., JW Pharmaceutical, among others. Treatment-Resistant Hypertension Market Treatment-Resistant Hypertension Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key TRD companies such as Ionis Pharmaceuticals, KBP Biosciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3Phase 2

25 Mar 2025

·www.globenewswire.com

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

Luke Laffin, MD, Cleveland Clinic, to discuss latest data from the pivotal Advance-HTN and Launch-HTN clinical trials and the potential of lorundrostat in hypertensionRADNOR, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today 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. Tuesday, April 1st @ 8:00 a.m. ETDomestic: 1-877-704-4453 International: 1-201-389-0920Webcast: Link A live webcast of the conference call may also be found on the “News & Events” page in the Investor Relations section of the Mineralys Therapeutics website. About Mineralys TherapeuticsMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn and Twitter. Contact:Investor Relationsinvestorrelations@mineralystx.com Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@elixirhealthpr.com

Clinical Study

12 Mar 2025

·www.globenewswire.com

Mineralys Therapeutics Announces Pricing of $175.0 Million Underwritten Public Offering of Common Stock

RADNOR, Pa., March 11, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today the pricing of an underwritten public offering of 12,962,962 shares of its common stock at a public offering price of $13.50 per share. The aggregate gross proceeds to Mineralys from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $175.0 million. In addition, Mineralys has granted the underwriters a 30-day option to purchase up to an additional 1,944,444 shares of its common stock. All of the securities to be sold in the offering are to be sold by Mineralys. The offering is expected to close on or about March 13, 2025, subject to the satisfaction of customary closing conditions. BofA Securities, Evercore ISI, Goldman Sachs & Co. LLC, Stifel and Wells Fargo Securities are acting as joint book-running managers for the offering. LifeSci Capital is acting as lead manager and H.C. Wainwright & Co. is acting as co-manager for the offering. 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. The securities described above are being offered by Mineralys pursuant to a shelf registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed, and a final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: BofA Securities NC1-022-02-25, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, North Carolina 28255-0001 or by email at dg.prospectus_requests@bofa.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, via telephone: (866) 471-2526, via fax: 212-902-9316, or via email: prospectus-ny@ny.email.gs.com; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, via telephone at (415) 364-2720 or via email at syndprospectus@stifel.com; or Wells Fargo Securities, LLC, Attention: WFS Customer Service, 608 2nd Avenue South, Suite 1000, Minneapolis, MN 55402, by telephone at 1-800-645-3751, or by email at wfscustomerservice@wellsfargo.com. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at http://www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. About MineralysMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the completion of the proposed public offering and the anticipated use of proceeds therefrom. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Mineralys’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with market conditions, the satisfaction of customary closing conditions related to the proposed public offering, and the other risks described in Mineralys’ filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mineralys undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. CONTACTS Investor Relationsinvestorrelations@mineralystx.com Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@elixirhealthpr.com

Clinical Study

100 Deals associated with Lorundrostat

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Resistant hypertension	Phase 3	United States	Mineralys Therapeutics, Inc.	22 Nov 2023
Resistant hypertension	Phase 3	Australia	Mineralys Therapeutics, Inc.	22 Nov 2023
Resistant hypertension	Phase 3	Bulgaria	Mineralys Therapeutics, Inc.	22 Nov 2023
Resistant hypertension	Phase 3	Canada	Mineralys Therapeutics, Inc.	22 Nov 2023
Resistant hypertension	Phase 3	France	Mineralys Therapeutics, Inc.	22 Nov 2023
Resistant hypertension	Phase 3	Germany	Mineralys Therapeutics, Inc.	22 Nov 2023
Resistant hypertension	Phase 3	Italy	Mineralys Therapeutics, Inc.	22 Nov 2023
Resistant hypertension	Phase 3	Netherlands	Mineralys Therapeutics, Inc.	22 Nov 2023
Resistant hypertension	Phase 3	Poland	Mineralys Therapeutics, Inc.	22 Nov 2023
Resistant hypertension	Phase 3	Puerto Rico	Mineralys Therapeutics, Inc.	22 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05769608 (ADVANCE-HTN, Company_Website) Manual	Phase 2	Resistant hypertension	-	Lorundrostat 50 mg	hiaxvibrhg(oczizspmvi) = aoxtsnjoub wgzldufykv (wvwwtfxnrj ) Met View more	Positive	10 Mar 2025
				Lorundrostat 50-100 mg	nmhxnvybin(gnxykqdoat) = kutqdczqtu ckfzdbgueq (dozbybvkzn )
NCT06153693 (Launch-HTN, Company_Website) Manual	Phase 3	Resistant hypertension	1,083	Lorundrostat 50 mg	cabgccwwud(xbyntsngek) = rbylhxthbw uxekwnhyoe (vgfnvfdlmv ) Met View more	Positive	10 Mar 2025
				Lorundrostat 50-100 mg	cabgccwwud(pmuvkazees) = rmmykhvxzt bezgldiilu (uefmpejwft ) View more
NCT05001945 (Target-HTN, CTgov)	Phase 2	Hypertension, Renal	200	Placebo (Placebo - Part 1)	uhyinzqjms(azbwisshzp) = skkfpmtedl zhdzlzcamw (zlnwdhijuh, 2.62) View more	-	05 Jan 2024
				Lorundrostat (Lorundrostat 12.5 mg BID - Part 1)	uhyinzqjms(azbwisshzp) = xgryybygcn zhdzlzcamw (zlnwdhijuh, 3.15) View more
NCT05001945 (Target-HTN, GlobeNewswire) Manual	Phase 2	Hypertension	200	lorundrostat	turwfdstmq(cqqxcpmyet) = ltvcwjvhrf kjeaqkhkhi (xqlpxonzob )	Positive	11 Nov 2023
				lorundrostat (50mg)	ydsvnmgcyj(zmzxryvcfi) = qsqlgyxexo uktxmyekgd (zklkrbwkzm )
NCT05001945 (Target-HTN, Pubmed) Manual	Phase 2	Hypertension	200	lorundrostat 12.5 mg	wtoqzdntxd(saxaqbdaop) = tvqwfvygib pwkksswwly (oyuspgswnv )	Positive	10 Sep 2023
				lorundrostat 25 mg	wtoqzdntxd(saxaqbdaop) = kgxyrblhfj pwkksswwly (oyuspgswnv )

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