Mineralys Therapeutics Presents Subgroup Analyses of Phase 3 Launch-HTN Trial Demonstrating Efficacy and Safety of Lorundrostat in Hypertension Participants with High Unmet Medical Need
Mineralys Therapeutics (NASDAQ:MLYS) announced positive subgroup analyses from its Phase 3 Launch-HTN trial for lorundrostat, a novel aldosterone synthase inhibitor for treating uncontrolled or resistant hypertension. The trial, the largest of its kind, demonstrated significant blood pressure reductions across diverse patient populations, including Black/African American (29%), adults ≥65 years (41%), women (47%), and participants with obesity (63%).
The 50mg lorundrostat dose showed clinically meaningful results, with a 16.9 mmHg reduction in blood pressure at Week 6 (-9.1 mmHg placebo adjusted; p<0.0001) and 19.0 mmHg reduction at Week 12 (-11.6 mmHg placebo adjusted; p<0.0001). The drug demonstrated a favorable safety profile with minimal adverse events. Mineralys plans to file a New Drug Application (NDA) with the FDA in Q4 2025 or Q1 2026.
Mineralys Therapeutics (NASDAQ:MLYS) ha comunicato analisi positive sui sottogruppi del suo trial di Fase 3 Launch-HTN per lorundrostat, un nuovo inibitore della aldosterone sintasi destinato al trattamento dell'ipertensione non controllata o resistente. Lo studio, il più ampio del suo genere, ha evidenziato riduzioni significative della pressione arteriosa in diversi gruppi di pazienti, inclusi afroamericani (29%), adulti ≥65 anni (41%), donne (47%) e partecipanti con obesità (63%).
La dose da 50 mg di lorundrostat ha mostrato risultati clinicamente rilevanti, con una riduzione della pressione di 16,9 mmHg alla settimana 6 (-9,1 mmHg rispetto a placebo; p<0,0001) e di 19,0 mmHg alla settimana 12 (-11,6 mmHg rispetto a placebo; p<0,0001). Il farmaco ha presentato un profilo di sicurezza favorevole con eventi avversi minimi. Mineralys prevede di presentare la domanda di registrazione (New Drug Application, NDA) alla FDA nel quarto trimestre 2025 o nel primo trimestre 2026.
Mineralys Therapeutics (NASDAQ:MLYS) anunció análisis positivos por subgrupos de su ensayo de fase 3 Launch-HTN con lorundrostat, un nuevo inhibidor de la aldosterona sintasa para el tratamiento de la hipertensión no controlada o resistente. El ensayo, el mayor de su tipo, mostró reducciones significativas de la presión arterial en distintas poblaciones, incluidos afroamericanos (29%), adultos ≥65 años (41%), mujeres (47%) y participantes con obesidad (63%).
La dosis de 50 mg de lorundrostat presentó resultados clínicamente relevantes, con una reducción de 16,9 mmHg en la presión arterial en la semana 6 (-9,1 mmHg ajustado por placebo; p<0,0001) y de 19,0 mmHg en la semana 12 (-11,6 mmHg ajustado por placebo; p<0,0001). El fármaco mostró un perfil de seguridad favorable con eventos adversos mínimos. Mineralys planea presentar una solicitud de aprobación de nuevo fármaco (New Drug Application, NDA) ante la FDA en el cuarto trimestre de 2025 o el primer trimestre de 2026.
Mineralys Therapeutics (NASDAQ:MLYS)는 비정상 혹은 저항성 고혈압 치료를 위한 새로운 알도스테론 합성효소 억제제인 로룬드로스탯(lorundrostat)에 대한 3상 Launch-HTN 시험의 하위군 분석에서 긍정적인 결과를 발표했습니다. 해당 임상은 동종 최대 규모로, 흑인/아프리카계(29%), 65세 이상 성인(41%), 여성(47%), 비만 참가자(63%) 등 다양한 환자군에서 유의한 혈압 감소를 보여주었습니다.
50mg 용량의 로룬드로스탯은 임상적으로 의미 있는 효과를 보였으며, 6주차에 혈압이 16.9 mmHg 감소(플라세보 대비 조정값 -9.1 mmHg; p<0.0001), 12주차에는 19.0 mmHg 감소(플라세보 대비 조정값 -11.6 mmHg; p<0.0001)를 나타냈습니다. 약물은 부작용이 적은 우수한 안전성 프로파일을 보였습니다. Mineralys는 2025년 4분기 또는 2026년 1분기에 FDA에 신약허가신청서(New Drug Application, NDA)를 제출할 계획입니다.
Mineralys Therapeutics (NASDAQ:MLYS) a annoncé des analyses positives par sous‑groupes de son essai de phase 3 Launch‑HTN pour le lorundrostat, un nouvel inhibiteur de l'aldostérone synthase destiné au traitement de l'hypertension non contrôlée ou résistante. L'étude, la plus vaste de ce type, a montré des réductions significatives de la pression artérielle dans divers groupes de patients, notamment les personnes noires/afro‑américaines (29 %), les adultes ≥65 ans (41 %), les femmes (47 %) et les participants obèses (63 %).
La dose de 50 mg de lorundrostat a donné des résultats cliniquement significatifs, avec une baisse de 16,9 mmHg à la semaine 6 (−9,1 mmHg ajusté vs placebo ; p<0,0001) et de 19,0 mmHg à la semaine 12 (−11,6 mmHg ajusté vs placebo ; p<0,0001). Le médicament a présenté un profil d'innocuité favorable avec peu d'effets indésirables. Mineralys prévoit de déposer une demande d'autorisation de mise sur le marché (New Drug Application, NDA) auprès de la FDA au T4 2025 ou T1 2026.
Mineralys Therapeutics (NASDAQ:MLYS) gab positive Subgruppenanalysen seiner Phase‑3‑Studie Launch‑HTN für Lorundrostat bekannt, einen neuartigen Aldosteron‑Synthase‑Inhibitor zur Behandlung von unkontrolliertem oder therapieresistentem Bluthochdruck. Die Studie, die größte ihrer Art, zeigte signifikante Blutdrucksenkungen in verschiedenen Patientengruppen, darunter Schwarze/Afroamerikaner (29 %), Erwachsene ≥65 Jahre (41 %), Frauen (47 %) und Teilnehmer mit Adipositas (63 %).
Die 50‑mg‑Dosis von Lorundrostat erzielte klinisch relevante Ergebnisse mit einer Blutdruckreduktion von 16,9 mmHg in Woche 6 (placebo‑korrigiert −9,1 mmHg; p<0,0001) und 19,0 mmHg in Woche 12 (placebo‑korrigiert −11,6 mmHg; p<0,0001). Das Präparat wies ein günstiges Sicherheitsprofil mit wenigen Nebenwirkungen auf. Mineralys plant, im Q4 2025 oder Q1 2026 eine New Drug Application (NDA) bei der FDA einzureichen.
- Significant blood pressure reductions across all participant subgroups
- Strong efficacy with 16.9 mmHg reduction at Week 6 and 19.0 mmHg at Week 12
- Favorable safety and tolerability profile with minimal serious adverse events
- Largest global Phase 3 trial to date in uncontrolled/resistant hypertension
- Diverse patient enrollment including high-risk populations
- Three subjects (0.6%) on lorundrostat showed elevated potassium levels >6.0 mmol/L
- Some anticipated effects on serum electrolytes were observed
Insights
Mineralys' Phase 3 data shows lorundrostat effectively treats hypertension across diverse high-risk groups with favorable safety profile.
The Phase 3 Launch-HTN trial results for lorundrostat represent a significant clinical advancement in hypertension treatment. The drug demonstrated consistent efficacy across diverse and traditionally difficult-to-treat populations, including Black/African American patients, older adults, women, and those with obesity—subgroups that have historically shown resistance to conventional treatments.
The data is particularly compelling when examining the placebo-adjusted systolic blood pressure reductions: -11.6 mmHg in patients ≥75 years, -6.7 mmHg in Black/African American patients, -9.4 mmHg in females, -9.6 mmHg in obese patients, and -9.0 mmHg in patients on ≥3 antihypertensive medications. These reductions are clinically meaningful, as even a 2 mmHg reduction in systolic blood pressure can significantly reduce cardiovascular mortality risk.
As an aldosterone synthase inhibitor, lorundrostat addresses a novel mechanism compared to standard antihypertensives. The trial's size (n=1,083) and diverse enrollment (29% Black/African American, 41% ≥65 years, 47% women, 63% with obesity) strengthen the findings' applicability to real-world populations.
The safety profile appears favorable, with limited on-target electrolyte effects. Hyperkalemia >6.0 mmol/L occurred in only 0.6% of treated patients versus 0.4% on placebo—a crucial observation since potassium elevation is a common concern with drugs affecting the renin-angiotensin-aldosterone system.
With plans to file an NDA between Q4 2025 and Q1 2026, Mineralys is approaching a critical regulatory milestone that could position lorundrostat as a valuable addition to the antihypertensive armamentarium, particularly for patients with resistant hypertension who comprise approximately 10-15% of all hypertensive patients.
~Pivotal Launch-HTN trial of novel aldosterone synthase inhibitor lorundrostat enrolled a diverse range of participants with uncontrolled or resistant hypertension~
~Subgroups - including Black or African American adults, older adults, women, and participants with comorbid obesity – face heightened risk of poor cardiovascular outcomes and represent high unmet need~
~Lorundrostat demonstrated significant and clinically meaningful blood pressure reductions across all participant subgroups, with a favorable safety and tolerability profile~
RADNOR, Pa., Sept. 05, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced new subgroup analyses from the Phase 3 Launch-HTN trial, evaluating the blood pressure–lowering efficacy and safety of lorundrostat in difficult-to-treat and high-risk patient populations with high unmet medical need. The results were presented at the American Heart Association (AHA) Hypertension Scientific Sessions in Baltimore, MD, September 4-7, 2025.
“In our Phase 3 Launch-HTN trial we were intentional about recruiting a diverse patient population, including those at high-risk. These participants continue to face uncontrolled hypertension despite treatment with existing therapies,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “Lorundrostat demonstrated a clinically meaningful blood pressure reduction across the full study population, including these difficult-to-treat groups. Importantly, the safety and tolerability profile was consistent with our topline results, reinforcing the potential of lorundrostat as a transformative therapeutic for patients living with uncontrolled or resistant hypertension.”
Launch-HTN is the largest global Phase 3 trial to date in uncontrolled or resistant hypertension, enrolling a diverse group of participants with high cardiovascular risk, including Black/African American (
"Hypertension remains the leading modifiable risk factor for cardiovascular disease. These findings from the Launch-HTN study highlight the potential of lorundrostat to address a critical unmet medical need and improve blood pressure control in high-risk patient cohorts, including: Black and African American patients, patients 65 yrs or older, females, patients with comorbid obesity and patients on 3 or more anti-hypertensives,” said Dr. Manish Saxena, MBBS, Hypertension Specialist and Clinical Co-Director at William Harvey Heart Centre, Barts Health NHS Trust and QMUL. “With consistent blood pressure lowering effect across diverse, high-risk subgroups, lorundrostat could help improve outcomes for patients and reduce the burden of hypertension on the healthcare system.”
Table. Subgroup Analysis of AOSBP Change for Lorundrostat 50 mg vs Placebo at Week 6
| LSM Reduction in AOSBP, mmHg | |||
| Characteristic | Lorundrostat 50 mg (n=808) | Placebo (n=270) | LSM Difference ( Placebo |
| Age | |||
| ≥75 y | -18.2 | -6.6 | -11.6 (-17.4, -5.8); p=0.0011 |
| 65-74 y | -16.7 | -9.8 | -6.9 (-11.4, -2.4); p=0.0109 |
| <65 y | -16.9 | -7.6 | -9.3 (-13.2, -5.4); p<0.0001 |
| Race | |||
| Black/African American | -15.1 | -8.3 | -6.7 (-11.6, -1.9); p<0.0222 |
| White | -17.1 | -8.0 | -9.2 (-12.8, -5.6); p<0.0001 |
| Sex | |||
| Female | -16.8 | -7.4 | -9.4 (-13.6, -5.3); p=0.0002 |
| Male | -17.0 | -8.2 | -8.8 (-12.6, -5.1); p<0.0001 |
| BMI, kg/m2 | |||
| ≥30 | -16.5 | -6.9 | -9.6 (-13.3, -5.8); p<0.0001 |
| <30 | -17.9 | -9.5 | -8.4 (-12.6, -4.3); p=0.0009 |
| Antihypertensive therapies | |||
| ≥3 | -17.2 | -8.1 | -9.0 (-12.7, -5.4); p<0.0001 |
| 2 | -16.1 | -7.2 | -8.8 (-13.2, -4.5); p=0.0009 |
AOSBP, automated office systolic blood pressure; LSM, least-squares mean.
Safety and tolerability outcomes were favorable across all groups in the trial, with results consistent with the overall study population. No new safety signals were observed, and adverse events were generally mild or moderate in severity.
The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled 1,083 eligible adult participants who failed to achieve their BP goal despite being on two to five antihypertensive medications. Launch-HTN reflects the real-world setting for clinicians by utilizing automated office blood pressure (AOBP) measurements and allowing participants to stay on their existing medications.
When added to existing background treatment, lorundrostat 50 mg dosed once daily demonstrated clinically meaningful, statistically significant mean reductions in AOBP with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted; p-value < 0.0001) that was sustained with a reduction of 19.0 mmHg at Week 12 (-11.6 mmHg placebo adjusted; p-value < 0.0001).
Lorundrostat demonstrated a favorable safety and tolerability profile in the Launch-HTN trial. The anticipated on-target effects on serum electrolytes, increased serum potassium and reduced serum sodium were modest and rapidly reversible upon discontinuation of lorundrostat. A confirmed serum potassium level of greater than 6.0 mmol/L occurred in three subjects (
Mineralys is moving forward with a New Drug Application (NDA) filing strategy and has scheduled a pre-NDA meeting with the FDA in the fourth quarter of 2025 and plans to file the NDA in the fourth quarter of 2025 or the first quarter of 2026.
About Hypertension
Having sustained, elevated BP (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States.1 In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause.2 Hypertension and related health issues resulted in an estimated annual economic burden of about
Less than
About Launch-HTN
The Launch-HTN trial (NCT06153693) was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled eligible adult participants who failed to achieve their blood pressure goal despite being on two to five background antihypertensive medications. Eligible participants were randomized to one of three arms: placebo, lorundrostat 50 mg once daily (QD), and lorundrostat 50 mg QD and then titrated to 100 mg QD, as needed, at week six. The primary endpoint of the trial was the change from baseline in systolic blood pressure versus placebo after six weeks of treatment, as measured by AOBP monitoring.
About Lorundrostat
Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40
About Mineralys Therapeutics
Mineralys 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 the treatment of 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, Twitter and Bluesky.
Forward Looking Statements
Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company’s expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company’s expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the anticipated timing of NDA submission and a potential pre-NDA meeting with the FDA; the Company’s ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of participants in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
References
1 CDC. Facts About Hypertension. Centers for Disease Control and Prevention. Updated September 27, 2023. Accessed June 2025.
2 CDC. Underlying Cause of Death, 1999–2022 Results. CDC WONDER Online Database. Accessed June 2025.
3 Centers for Disease Control and Prevention. Health and Economic Benefits of High Blood Pressure Interventions. National Center for Chronic Disease Prevention and Health Promotion. Updated November 20, 2023. Accessed June 2025.
4 Carey RM, et al. Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement from the AHA. Hypertension. 2018;72(5):e53-e90.
5 Brown JM, et al. Primary Aldosteronism and the Pathogenesis of Hypertension. Physiol Rev. 2018;98(1):103-137.
Contact:
Investor Relations
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Media Relations
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Elixir Health Public Relations
Email: mweible@elixirhealthpr.com
FAQ
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