Product Description
MLS-101 is a Highly Selective Aldosterone Synthase Inhibitor Designed to Address Abnormally Elevated Aldosterone, an Underlying Cause of Hypertension Prevalent in a Significant Portion of Patients. (Sourced from: https://www.benzinga.com/pressreleases/22/06/n27604835/mineralys-therapeutics-closes-118-million-oversubscribed-series-b-financing-to-advance-the-develop)
Mechanisms of Action: Aldosterone Synthase Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Mineralys Therapeutics Inc.
Company Location:
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Bulgaria, Canada, France, Germany, Italy, Netherlands, Poland, Puerto Rico, Romania, Spain, United Kingdom, United States
Active Clinical Trial Count:
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Mineralys Therapeutics presented P2 Sleep Apnea, Obstructive|Hypertension results on 2026-10-09 for Lorundrostat
- Clinical Outcomes Reported - Mineralys Therapeutics presented P3 Resistant Hypertension results on 2026-10-09 for Lorundrostat
- Clinical Outcomes Reported - Mineralys Therapeutics presented P2 Sleep Apnea, Obstructive|Hypertension results on 2026-10-08 for Lorundrostat
Highest Development Phases
Phase 3: Hypertension|Resistant Hypertension
Phase 2: Albuminuria|Hypertension, Renal|Kidney Failure, Chronic|Sleep Apnea, Obstructive
Phase 1: Depressive Disorder, Major|Healthy Volunteers|Premenstrual Dysphoric Disorder
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06785454 |
MLS-101-207 | P2 |
Completed |
Hypertension|Sleep Apnea, Obstructive |
2025-12-17 |
2026-01-14 |
||
2023-508670-28-00 |
MLS-101-901 | P3 |
Active, not recruiting |
Resistant Hypertension |
2027-09-30 |
2025-05-02 |
Treatments |
|
NCT05968430 |
MLS-101-901 | P3 |
Active, not recruiting |
Hypertension |
2025-12-30 |
15% |
2026-01-31 |
Primary Endpoints |
NCT06150924 |
MLS-101-206 | P2 |
Completed |
Kidney Failure, Chronic|Albuminuria|Hypertension, Renal |
2025-02-27 |
2025-07-09 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT07818720 |
MLS101-104 | P1 |
Not yet recruiting |
Depressive Disorder, Major|Premenstrual Dysphoric Disorder |
2027-09-01 |
2% |
2026-09-15 |
|
NCT06153693 |
MLS-101-301 | P3 |
Completed |
Hypertension |
2024-12-10 |
3% |
2025-02-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06643637 |
24-MLS101-102 | P1 |
Completed |
Healthy Volunteers |
2025-03-12 |
2025-06-13 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT06326606 |
23-MLS101-101 | P1 |
Recruiting |
Healthy Volunteers |
2024-08-01 |
2024-07-23 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
|
NCT05769608 |
MLS-101-202 | P2 |
Completed |
Hypertension |
2025-01-15 |
2025-02-19 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
2023-506425-12-00 |
MLS-101-301 | P3 |
Completed |
Resistant Hypertension |
2025-01-16 |
2025-05-02 |
Treatments |