Mineralys Therapeutics Announces Journal of the American Medical Association (JAMA) Publication of Pivotal Phase 3 Launch-HTN Trial for Lorundrostat
Mineralys Therapeutics (NASDAQ: MLYS) has published positive results from its pivotal Phase 3 Launch-HTN trial for lorundrostat in the Journal of the American Medical Association (JAMA). The trial, which is the largest study of an aldosterone synthase inhibitor in patients with uncontrolled or treatment-resistant hypertension, enrolled 1,083 participants.
The study demonstrated that lorundrostat 50 mg once daily achieved significant blood pressure reductions: 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted; p-value < 0.0001) and 19.0 mmHg reduction at Week 12 (-11.7 mmHg placebo adjusted; p-value < 0.0001). These benefits were consistent across various patient demographics.
The drug showed a favorable safety profile with mostly mild, transient adverse events. Only 0.6% of patients on lorundrostat experienced elevated potassium levels above 6.0 mmol/L, compared to 0.4% in the placebo group. The trial included patients on two to five existing antihypertensive medications and utilized automated office blood pressure measurements to reflect real-world clinical settings.
Mineralys Therapeutics (NASDAQ: MLYS) ha pubblicato risultati positivi del suo studio pivotale di Fase 3 Launch-HTN per lorundrostat sul Journal of the American Medical Association (JAMA). Lo studio, il più ampio condotto su un inibitore della sintasi dell'aldosterone in pazienti con ipertensione non controllata o resistente al trattamento, ha arruolato 1.083 partecipanti.
Lo studio ha dimostrato che lorundrostat 50 mg una volta al giorno ha ottenuto riduzioni significative della pressione arteriosa: una riduzione di 16,9 mmHg alla settimana 6 (-9,1 mmHg rispetto al placebo; p < 0,0001) e una riduzione di 19,0 mmHg alla settimana 12 (-11,7 mmHg rispetto al placebo; p < 0,0001). Questi benefici sono stati costanti in diversi gruppi demografici di pazienti.
Il farmaco ha mostrato un profilo di sicurezza favorevole con eventi avversi per lo più lievi e transitori. Solo lo 0,6% dei pazienti trattati con lorundrostat ha presentato livelli di potassio superiori a 6,0 mmol/L, rispetto allo 0,4% nel gruppo placebo. Lo studio ha incluso pazienti in trattamento con due-cinque farmaci antipertensivi e ha utilizzato misurazioni automatiche della pressione arteriosa in ambulatorio per riflettere le condizioni cliniche reali.
Mineralys Therapeutics (NASDAQ: MLYS) ha publicado resultados positivos de su ensayo pivotal de Fase 3 Launch-HTN para lorundrostat en el Journal of the American Medical Association (JAMA). El estudio, el más grande realizado con un inhibidor de la sintasa de aldosterona en pacientes con hipertensión no controlada o resistente al tratamiento, incluyó a 1,083 participantes.
El estudio demostró que lorundrostat 50 mg una vez al día logró reducciones significativas en la presión arterial: una reducción de 16.9 mmHg en la semana 6 (-9.1 mmHg ajustado por placebo; p < 0.0001) y una reducción de 19.0 mmHg en la semana 12 (-11.7 mmHg ajustado por placebo; p < 0.0001). Estos beneficios fueron consistentes en diferentes grupos demográficos.
El medicamento mostró un perfil de seguridad favorable con eventos adversos principalmente leves y transitorios. Solo el 0.6% de los pacientes tratados con lorundrostat presentó niveles elevados de potasio por encima de 6.0 mmol/L, comparado con el 0.4% en el grupo placebo. El ensayo incluyó pacientes que usaban de dos a cinco medicamentos antihipertensivos y utilizó mediciones automáticas de la presión arterial en consultorio para reflejar condiciones clínicas reales.
Mineralys Therapeutics (NASDAQ: MLYS)는 lorundrostat에 대한 중추적인 3상 Launch-HTN 임상시험 결과를 미국 의학 협회 저널(JAMA)에 발표했습니다. 이 시험은 조절되지 않거나 치료 저항성 고혈압 환자에서 알도스테론 합성효소 억제제에 대한 최대 규모의 연구로, 1,083명 참가자를 등록했습니다.
연구 결과 lorundrostat 50mg 1일 1회 투여 시 혈압이 유의미하게 감소했으며, 6주차에 16.9 mmHg 감소(위약 대비 -9.1 mmHg; p < 0.0001), 12주차에 19.0 mmHg 감소(위약 대비 -11.7 mmHg; p < 0.0001)를 보였습니다. 이러한 효과는 다양한 환자 인구통계학적 특성에서 일관되게 나타났습니다.
약물은 주로 경미하고 일시적인 부작용으로 안전성 프로파일이 양호했습니다. lorundrostat 투여군에서 혈중 칼륨 수치가 6.0 mmol/L 이상으로 상승한 환자는 0.6%에 불과했으며, 위약군에서는 0.4%였습니다. 이 임상시험은 2~5종의 기존 항고혈압제를 복용 중인 환자를 포함했으며, 실제 임상 환경을 반영하기 위해 자동화된 진료실 혈압 측정을 사용했습니다.
Mineralys Therapeutics (NASDAQ : MLYS) a publié des résultats positifs de son essai pivot de phase 3 Launch-HTN pour le lorundrostat dans le Journal of the American Medical Association (JAMA). Cet essai, la plus grande étude réalisée sur un inhibiteur de la synthase de l'aldostérone chez des patients souffrant d'hypertension non contrôlée ou résistante au traitement, a inclus 1 083 participants.
L'étude a démontré que le lorundrostat 50 mg une fois par jour permettait des réductions significatives de la pression artérielle : une baisse de 16,9 mmHg à la semaine 6 (-9,1 mmHg ajusté par rapport au placebo ; p < 0,0001) et une baisse de 19,0 mmHg à la semaine 12 (-11,7 mmHg ajusté par rapport au placebo ; p < 0,0001). Ces bénéfices étaient constants à travers différents profils de patients.
Le médicament a présenté un profil de sécurité favorable avec des effets indésirables principalement légers et transitoires. Seuls 0,6 % des patients sous lorundrostat ont présenté des taux de potassium supérieurs à 6,0 mmol/L, contre 0,4 % dans le groupe placebo. L'essai a inclus des patients sous deux à cinq médicaments antihypertenseurs et a utilisé des mesures automatiques de la pression artérielle en cabinet pour refléter les conditions cliniques réelles.
Mineralys Therapeutics (NASDAQ: MLYS) hat positive Ergebnisse seiner entscheidenden Phase-3-Studie Launch-HTN für Lorundrostat im Journal of the American Medical Association (JAMA) veröffentlicht. Die Studie, die die größte Untersuchung eines Aldosteron-Synthase-Inhibitors bei Patienten mit unkontrolliertem oder therapieresistentem Bluthochdruck darstellt, umfasste 1.083 Teilnehmer.
Die Studie zeigte, dass Lorundrostat 50 mg einmal täglich signifikante Blutdrucksenkungen erzielte: eine Reduktion um 16,9 mmHg in Woche 6 (-9,1 mmHg placebo-adjustiert; p < 0,0001) und eine Reduktion um 19,0 mmHg in Woche 12 (-11,7 mmHg placebo-adjustiert; p < 0,0001). Diese Vorteile zeigten sich konsistent über verschiedene Patientendemografien hinweg.
Das Medikament zeigte ein günstiges Sicherheitsprofil mit überwiegend milden, vorübergehenden Nebenwirkungen. Nur 0,6% der Patienten unter Lorundrostat hatten erhöhte Kaliumwerte über 6,0 mmol/L, verglichen mit 0,4% in der Placebogruppe. Die Studie schloss Patienten ein, die zwei bis fünf bestehende blutdrucksenkende Medikamente einnahmen, und verwendete automatisierte Blutdruckmessungen im Büro, um reale klinische Bedingungen abzubilden.
- Significant blood pressure reduction of 19.0 mmHg at Week 12 (placebo-adjusted -11.7 mmHg)
- Consistent efficacy across diverse patient demographics including age, sex, race, and BMI
- Favorable safety and tolerability profile with mostly mild, transient adverse events
- Large-scale Phase 3 trial with 1,083 participants demonstrating robust data
- Publication in prestigious JAMA journal validating clinical significance
- Three subjects (0.6%) on lorundrostat experienced elevated potassium levels above 6.0 mmol/L
- Some effects on serum electrolytes were observed, though modest and reversible
Insights
Mineralys' lorundrostat shows strong Phase 3 results with significant blood pressure reductions and favorable safety profile, advancing toward potential FDA approval.
The publication of Mineralys Therapeutics' Phase 3 Launch-HTN trial results in JAMA represents a significant milestone in hypertension treatment development. This is the largest trial of an aldosterone synthase inhibitor ever completed in patients with uncontrolled or treatment-resistant hypertension, involving 1,083 participants who remained hypertensive despite taking 2-5 medications.
The data is particularly compelling: lorundrostat 50mg once daily demonstrated systolic blood pressure reductions of 16.9 mmHg at week 6 and 19.0 mmHg at week 12 (placebo-adjusted reductions of 9.1 mmHg and 11.7 mmHg, respectively, with p-values <0.0001). These are substantial reductions for treatment-resistant hypertension patients, for whom each additional mmHg reduction can translate to meaningful cardiovascular risk reduction.
The trial's design adds credibility to the results by utilizing automated office blood pressure measurements and allowing participants to continue existing medications – conditions that closely mirror real-world clinical practice. The diverse participant demographics (high proportions of females, Black/African American, and elderly participants) further strengthen the generalizability of these findings.
From a safety perspective, lorundrostat demonstrated a favorable profile with only 0.6% of participants experiencing confirmed serum potassium levels above 6.0 mmol/L (compared to 0.4% on placebo). The absence of cortisol suppression is particularly important, as this has been a concern with some other medications affecting the renin-angiotensin-aldosterone system.
The focus on aldosterone synthase inhibition represents an innovative mechanistic approach. Dysregulated aldosterone affects up to 30% of all hypertensive patients and is particularly prevalent in treatment-resistant cases. Current treatment options for resistant hypertension are limited, making lorundrostat a potentially valuable addition to the therapeutic armamentarium if approved.
– The Launch-HTN trial is the largest trial of an aldosterone synthase inhibitor completed in participants with uncontrolled or treatment resistant hypertension –
– Lorundrostat 50 mg once daily demonstrated clinically meaningful reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 and a 19.0 mmHg reduction at Week 12 –
– Lorundrostat was generally well-tolerated; and treatment-emergent adverse events were mostly mild, transient, and resolved without intervention –
RADNOR, Pa., June 30, 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 the publication of the positive results from the pivotal Phase 3 Launch-HTN trial in the Journal of the American Medical Association (JAMA). The manuscript titled “Lorundrostat in Participants with Uncontrolled and Treatment-Resistant Hypertension” is featured in the June 30, 2025 issue.
The Launch-HTN trial evaluated the efficacy and safety of lorundrostat, a novel aldosterone synthase inhibitor (ASI), when added to existing background treatment in 1,083 participants with uncontrolled or treatment resistant hypertension. The trial demonstrated that lorundrostat significantly reduced systolic blood pressure (BP) with a favorable safety and tolerability profile.
“Hypertension remains the most prevalent and preventable driver of cardiovascular disease globally, yet a significant proportion of patients continue to struggle with inadequate blood pressure control. We believe lorundrostat has the potential to be a best-in-class treatment for patients with uncontrolled or treatment resistant hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “We are pleased to have the results of Launch-HTN published in a medical journal as prestigious as JAMA. The consistency of results seen in the lorundrostat development program – which includes multiple trials across differentiated patient populations – supports its potential to have a broad role in future hypertension care.”
“Launch-HTN was the largest Phase 3 trial of an ASI in patients with uncontrolled or resistant hypertension, designed to reflect usual clinical practice. It demonstrated consistent blood pressure lowering efficacy and safety with the aldosterone synthase inhibitor, lorundrostat, across a diverse group of patients,” said Dr. Manish Saxena, MBBS, Deputy Clinical Co-Director of Queen Mary University of London’s William Harvey Heart Centre, and Hypertension Specialist at Barts Health NHS Trust and lead investigator on the study. “Dysregulated aldosterone, a key factor in driving hypertension in up to
Key Findings from Launch-HTN
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. Authors noted that the trial recruited a diverse population as reflected in the high proportion of females, Black or African American and elderly participants.
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 (-11.7 mmHg placebo adjusted; p-value < 0.0001). These benefits were consistent across age, sex, race, body mass index, and baseline medication regimen.
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 (
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 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 ASIs 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 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.
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