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- | Journal: Targeting aldosterone to improve cardiorenal outcomes: from nonsteroidal mineralocorticoid receptor antagonists to aldosterone synthase inhibitors. (Pubmed Central) - Feb 27, 2025
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.
- ||||||| lorundrostat (MT-4129) / Mineralys Therap
Trial completion: Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension (clinicaltrials.gov) - Feb 24, 2025
P3, N=1083, Completed, Sponsor: Mineralys Therapeutics Inc.
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. Active, not recruiting --> Completed
- |||| lorundrostat (MT-4129) / Mineralys Therap
Trial completion: A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen (clinicaltrials.gov) - Feb 18, 2025
P2, N=285, Completed, Sponsor: Mineralys Therapeutics Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- lorundrostat (MT-4129) / Mineralys Therap
Efficacy Of Lorundrostat, A Novel Aldosterone Synthase Inhibitor, In Patients With Uncontrolled Hypertension On A Standardized Antihypertensive Medication Regimen - Luke Laffin (Main Tent) - Jan 27, 2025 - Abstract #ACC2025ACC_1696;
- ||||| lorundrostat (MT-4129) / Mineralys Therap
Enrollment closed, Trial completion date: Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension (clinicaltrials.gov) - Nov 18, 2024
P3, N=1083, Active, not recruiting, Sponsor: Mineralys Therapeutics Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Jul 2025 --> Feb 2025
- ||| lorundrostat (MT-4129) / Mineralys Therap
Enrollment closed, Trial completion date, Trial primary completion date: A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen (clinicaltrials.gov) - Nov 18, 2024
P2, N=285, Active, not recruiting, Sponsor: Mineralys Therapeutics Inc.
Recruiting --> Active, not recruiting | Trial completion date: Jul 2025 --> Feb 2025 Recruiting --> Active, not recruiting | Trial completion date: Oct 2024 --> Feb 2025 | Trial primary completion date: Sep 2024 --> Jan 2025
- |||| lorundrostat (MT-4129) / Mineralys Therap
Enrollment status: Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension (clinicaltrials.gov) - Oct 15, 2024
P3, N=1400, Enrolling by invitation, Sponsor: Mineralys Therapeutics Inc.
Recruiting --> Active, not recruiting | Trial completion date: Oct 2024 --> Feb 2025 | Trial primary completion date: Sep 2024 --> Jan 2025 Recruiting --> Enrolling by invitation
- || psilocybin low-dose (MLS101) / MycoMedica
Trial completion: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants (clinicaltrials.gov) - Oct 9, 2024
P1, N=24, Completed, Sponsor: MycoMedica Life Sciences PBC
Recruiting --> Enrolling by invitation Recruiting --> Completed
- || lorundrostat (MT-4129) / Mineralys Therap
Clinical, P1 data, PK/PD data, Journal: First-in-human study evaluating safety, pharmacokinetics, and pharmacodynamics of lorundrostat, a novel and highly selective aldosterone synthase inhibitor. (Pubmed Central) - Aug 17, 2024
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.
- ||||| lorundrostat (MT-4129) / Mineralys Therap
Phase classification, Enrollment change, Trial completion date: Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension (clinicaltrials.gov) - Jul 22, 2024
P3, N=1400, Recruiting, Sponsor: Mineralys Therapeutics Inc.
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. Phase classification: P2/3 --> P3 | N=900 --> 1400 | Trial completion date: Dec 2025 --> Dec 2026
- || psilocybin low-dose (MLS101) / MycoMedica
Enrollment change: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants (clinicaltrials.gov) - May 6, 2024
P1, N=24, Recruiting, Sponsor: MycoMedica Life Sciences PBC
Phase classification: P2/3 --> P3 | N=900 --> 1400 | Trial completion date: Dec 2025 --> Dec 2026 N=80 --> 24
- || Clinical, Review, Journal: Systematic Review Article: New Drug Strategies for Treating Resistant Hypertension-the Importance of a Mechanistic, Personalized Approach. (Pubmed Central) - Apr 24, 2024
These novel drugs, which are orally administered and are able to antagonize different pathophysiological pathways, are represented by non-steroid mineralocorticorticoid receptor antagonists, selective aldosterone synthase inhibitors, and dual endothelin receptor antagonists, all of which have proven to reduce seated office and 24-h ambulatory systolic/diastolic BP levels. The main findings of randomized
- | psilocybin low-dose (MLS101) / MycoMedica
New P1 trial: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants (clinicaltrials.gov) - Mar 22, 2024
P1, N=80, Recruiting, Sponsor: MycoMedica Life Sciences PBC
- || lorundrostat (MT-4129) / Mineralys Therap
Review, Journal: Emerging Therapies for Treatment-Resistant Hypertension: A Review of Lorundrostat and Related Selective Aldosterone Synthase Inhibitors. (Pubmed Central) - Feb 15, 2024
Lorundrostat is more selective for the inhibition of CYP11B2 versus CYP11B1, which makes it preferable to other aldosterone synthase inhibitors that inhibit cortisol synthesis, such as osilodrostat. Phase 3 trials are needed to validate the safety and efficacy of lorundrostat, and further research should be performed on other selective aldosterone synthase inhibitors such as baxdrostat, dexfadrostat, and BI 690517.
- ||| lorundrostat (MT-4129) / Mineralys Therap
Enrollment open, Combination therapy: 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 (clinicaltrials.gov) - Jan 9, 2024
P2, N=80, Recruiting, Sponsor: Mineralys Therapeutics Inc.
Phase 3 trials are needed to validate the safety and efficacy of lorundrostat, and further research should be performed on other selective aldosterone synthase inhibitors such as baxdrostat, dexfadrostat, and BI 690517. Not yet recruiting --> Recruiting
- || lorundrostat (MT-4129) / Mineralys Therap
P2 data, Journal: More on aldosterone biosynthesis inhibition and resistant hypertension: a Phase-2 study with lorundrostat. (Pubmed Central) - Jan 8, 2024
Not yet recruiting --> Recruiting No abstract available
- |||||| lorundrostat (MT-4129) / Mineralys Therap
Enrollment open: Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension (clinicaltrials.gov) - Dec 21, 2023
P3, N=1000, Recruiting, Sponsor: Mineralys Therapeutics Inc.
No abstract available Not yet recruiting --> Recruiting
- || lorundrostat (MT-4129) / Mineralys Therap
Review, Journal: Hypertension and Lorundrostat: Key Discoveries from the TARGET-HTN Trial. (Pubmed Central) - Dec 17, 2023
In conclusion, the Target-HTN trial has demonstrated that lorundrostat, an aldosterone synthase inhibitor, holds promise as an innovative therapeutic approach for reducing systolic blood pressure, especially in hypertensive patients with suppressed plasma renin activity and elevated serum aldosterone levels. These findings advocate for the initiation of Phase 3 trials to further validate the safety and efficacy of lorundrostat in a larger and more diverse patient population.
- |||| lorundrostat (MT-4129) / Mineralys Therap
Trial completion date, Trial primary completion date: Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension (clinicaltrials.gov) - Dec 5, 2023
P2/3, N=900, Recruiting, Sponsor: Mineralys Therapeutics Inc.
These findings advocate for the initiation of Phase 3 trials to further validate the safety and efficacy of lorundrostat in a larger and more diverse patient population. .
- |||||||||| lorundrostat (MT-4129) / Mineralys Therap
New P3 trial: Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension (clinicaltrials.gov) - Nov 30, 2023
P3, N=1000, Not yet recruiting, Sponsor: Mineralys Therapeutics Inc.
. .
- |||| lorundrostat (MT-4129) / Mineralys Therap
New P2 trial, Combination therapy: 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 (clinicaltrials.gov) - Nov 29, 2023
P2, N=80, Not yet recruiting, Sponsor: Mineralys Therapeutics Inc.
- || lorundrostat (MT-4129) / Mineralys Therap
Trial completion date, Trial primary completion date: A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen (clinicaltrials.gov) - Nov 28, 2023
P2, N=261, Recruiting, Sponsor: Mineralys Therapeutics Inc.
- || lorundrostat (MT-4129) / Mineralys Therap
Clinical, Journal: Aldosterone Synthase Inhibition With Lorundrostat for Uncontrolled Hypertension: The Target-HTN Randomized Clinical Trial. (Pubmed Central) - Sep 10, 2023
P2
Among individuals with uncontrolled hypertension, use of lorundrostat was effective at lowering blood pressure compared with placebo, which will require further confirmatory studies. ClinicalTrials.gov Identifier: NCT05001945.
- ||||| lorundrostat (MT-4129) / Mineralys Therap
Trial initiation date: Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension (clinicaltrials.gov) - Aug 14, 2023
P2/3, N=900, Recruiting, Sponsor: Mineralys Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05001945. Initiation date: Mar 2023 --> Jul 2023
- lorundrostat (MT-4129) / Mineralys Therap
Lorundrostat for Treatment of Obesity-Related, Aldosterone-Dependent Hypertension - An Endotype-Specific, Targeted Approach to the Treatment of Uncontrolled Hypertension (Zone 4, Science and Technology Hall, Level 200) - Aug 12, 2023 - Abstract #AHA2023AHA_4062;
Initiation date: Mar 2023 --> Jul 2023 Abstract is embargoed at this time.
- |||||| lorundrostat (MT-4129) / Mineralys Therap
Enrollment open, Trial initiation date: Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension (clinicaltrials.gov) - Aug 4, 2023
P2/3, N=900, Recruiting, Sponsor: Mineralys Therapeutics Inc.
Abstract is embargoed at this time. Not yet recruiting --> Recruiting | Initiation date: Jul 2023 --> Mar 2023
- |||||||||| lorundrostat (MT-4129) / Mineralys Therap
New P2/3 trial: Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension (clinicaltrials.gov) - Aug 1, 2023
P2/3, N=900, Not yet recruiting, Sponsor: Mineralys Therapeutics Inc.
- ||||| lorundrostat (MT-4129) / Mineralys Therap
New P2 trial: A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen (clinicaltrials.gov) - Mar 15, 2023
P2, N=300, Recruiting, Sponsor: Mineralys Therapeutics Inc.
- ||| lorundrostat (MT-4129) / Mineralys Therap
Trial completion: Target-HTN: Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension (clinicaltrials.gov) - Feb 21, 2023
P2, N=200, Completed, Sponsor: Mineralys Therapeutics Inc.
Not yet recruiting --> Recruiting | Initiation date: Jul 2023 --> Mar 2023 Recruiting --> Completed
- MT-4129 / Mineralys Therap
FIRST-IN-HUMAN STUDY OF MLS-101, A POTENT AND HIGHLY SELECTIVE ALDOSTERONE SYNTHASE INHIBITOR (Poster Hall_Hall F) - Jan 4, 2023 - Abstract #ACCWCC2023ACC_WCC_1662;
In contrast with aldosterone receptor blockers, which increase aldosterone production, MLS-101 produced comparable renal effects while substantially reducing circulating aldosterone. As aldosterone can signal via both genomic and non-genomic pathways, there is potential for this new class of antihypertensive to differentiate from mineralocorticoid receptor antagonists in individuals with hypertension and other cardiorenal conditions.
- MT-4129 / Mineralys Therap
HIGHLY EFFECTIVE BLOOD PRESSURE LOWERING WITH MLS-101, A NEW ALDOSTERONE SYNTHASE INHIBITOR, IN INDIVIDUALS WITH OBESITY AND RAAS DYSREGULATION (Heart Failure and Cardiomyopathies Moderated Poster Theater 9_Hall F) - Jan 4, 2023 - Abstract #ACCWCC2023ACC_WCC_1336;
MLS-101 demonstrated robust BP reduction during wakefulness and sleep. This is the first antihypertensive in a randomized, placebo-controlled trial demonstrated to be uniquely effective in an obese hypertensive population.
- lorundrostat (MT-4129) / Mineralys Therap
Lorundrostat for Treatment of Obesity-Related, Aldosterone-Dependent Hypertension - An Endotype-Specific, Targeted Approach to the Treatment of Uncontrolled Hypertension (Zone 4, Science and Technology Hall, Level 200) - Aug 11, 2022 - Abstract #AHA2022AHA_4062;
This is the first antihypertensive in a randomized, placebo-controlled trial demonstrated to be uniquely effective in an obese hypertensive population. Abstract is embargoed at this time.
- | lorundrostat (MT-4129) / Mineralys Therap
New P2 trial: Target-HTN: Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension (clinicaltrials.gov) - Aug 11, 2021
P2, N=180, Recruiting, Sponsor: Mineralys Therapeutics Inc.
- ||| lorundrostat (MT-4129) / Mineralys Therap
Trial completion: A Clinical Study to See How the Study Drug MT-4129 is Taken up by the Body in Healthy Volunteers (clinicaltrials.gov) - May 18, 2017
P1, N=116, Completed, Sponsor: Mitsubishi Tanabe Pharma Corporation
Abstract is embargoed at this time. Recruiting --> Completed
- ||| lorundrostat (MT-4129) / Mineralys Therap
Enrollment open: A Clinical Study to See How the Study Drug MT-4129 is Taken up by the Body in Healthy Volunteers (clinicaltrials.gov) - Dec 13, 2016
P1, N=116, Recruiting, Sponsor: Mitsubishi Tanabe Pharma Corporation
Recruiting --> Completed Not yet recruiting --> Recruiting
- ||| lorundrostat (MT-4129) / Mineralys Therap
New P1 trial: A Clinical Study to See How the Study Drug MT-4129 is Taken up by the Body in Healthy Volunteers (clinicaltrials.gov) - Nov 2, 2016
P1, N=116, Not yet recruiting, Sponsor: Mitsubishi Tanabe Pharma Corporation