Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06153693 | Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension | PHASE3 | COMPLETED | 1,083 | — | — | Nov 22, 2023 | Jan 24, 2025 | May 1, 2026 | 184 | United States, Australia +11 |
| NCT05968430 | Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension | PHASE3 | ACTIVE NOT_RECRUITING | 1,076 | — | — | Jul 14, 2023 | Dec 1, 2026 | Feb 17, 2026 | 177 | United States, Australia +11 |
| NCT05769608 | A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen | PHASE2 | COMPLETED | 285 | — | — | Mar 13, 2023 | Jan 15, 2025 | Jan 20, 2026 | 104 | United States |
Change from MLS-101-301 baseline automated office blood pressure (AOBP) systolic blood pressure (SBP) at MLS-101-901 Week 36 in subjects who were enrolled in the lorundrostat arms of MLS-101-301 and were not assigned to the placebo arm of the MLS-101-901 RTW substudy
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo once daily (QD) for 12 weeks |
| Dose 1 | EXPERIMENTAL | 50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks |
| Dose 2 | EXPERIMENTAL | 50 mg lorundrostat Dose 1 once daily (QD) for 6 weeks then 100 mg lorundrostat Dose 2 once daily (QD) for 6 weeks for subjects who meet prespecified criteria |
| Open-Label Arm | EXPERIMENTAL | lorundrostat once daily for 52 weeks depending on when the subject enrolled |
| RTW Substudy | EXPERIMENTAL | lorundrostat or placebo once daily for 4 weeks starting at week 12, in the double-blind randomized treatment withdrawal substudy Optional for subjects from the MLS-101-301 parent study only |
| Optional Continuation Period | EXPERIMENTAL | lorundrostat once daily from week 52 or until marketing authorization or early termination of the trial by the sponsor |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo once daily (QD) for 12 weeks |
| lorundrostat Dose 1 | DRUG | 50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks |
| lorundrostat Dose 2 | DRUG | 50 mg lorundrostat Dose 1 once daily (QD) for 6 weeks then 100 mg lorundrostat Dose 2 once daily (QD) for 6 weeks for subjects who meet prespecified criteria |
| lorundrostat | DRUG | Tablet, administered orally |
Inclusion Criteria: 1. At least 18 years of age at the time of signing the informed consent form (ICF) 2. At Screening and Randomization: AOBP SBP of ≥135 and ≤180 mmHg plus AOBP DBP of ≥65 and ≤110 mmHg, or AOBP DBP of ≥90 and ≤110 mmHg 3. Taking between 2 and 5 AHT medications, 4. History of hype...