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lorundrostat · 4 trials · 2 indications
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 |
| Sequence 1: Lorundrostat then Placebo | EXPERIMENTAL | - |
| Sequence 2: Placebo then Lorundrostat | EXPERIMENTAL | - |
| 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...
Lorundrostat is an investigational small molecule being developed for hypertension and for obstructive sleep apnea with hypertension. It is a -stat class enzyme inhibitor under evaluation in clinical trials for these cardiovascular conditions.
Lorundrostat is being developed by Mineralys Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol MLYS.
Lorundrostat is in clinical development. It has completed Phase 2 trials in hypertension and in obstructive sleep apnea with hypertension, and it has been studied in Phase 3 trials for hypertension. It remains investigational and is not approved.
Lorundrostat has been studied in several trials. NCT05769608 was a Phase 2 study in uncontrolled hypertension, NCT05968430 is an active Phase 3 open-label extension in hypertension, NCT06153693 was a Phase 3 study in uncontrolled and resistant hypertension, and NCT06785454 was a Phase 2 study in obstructive sleep apnea with hypertension.
Lorundrostat is the drug name used in clinical trials for this investigational therapy. No alternative names have been reported for this compound.