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Also known as lorundrostat Dose 1
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 oral small molecule being developed for hypertension, including uncontrolled and resistant hypertension, and for obstructive sleep apnea in patients who also have hypertension. It is not yet approved and remains in clinical development, with a New Drug Application stage reached in its regulatory path.
Lorundrostat targets CYP11B2, also known as aldosterone synthase. By inhibiting this enzyme, lorundrostat is designed to reduce aldosterone production, which is a driver of sodium retention and elevated blood pressure in hypertension. It belongs to the enzyme inhibitor class of small molecule therapeutics.
Lorundrostat is developed by Mineralys Therapeutics, Inc., which trades on the Nasdaq under the ticker MLYS. The company is the sponsor of the clinical program evaluating lorundrostat in hypertension and in obstructive sleep apnea with hypertension.
Lorundrostat has reached the NDA or BLA stage of development, meaning the sponsor has advanced toward regulatory submission. It is investigational and has not been approved. The program includes completed Phase 2 and Phase 3 trials plus an ongoing open-label extension study.
Lorundrostat has been studied in four registered trials. NCT06153693 was a Phase 3 trial in uncontrolled and resistant hypertension with 1,083 participants, and NCT05769608 was a Phase 2 pivotal study in uncontrolled hypertension with 285 participants. NCT05968430 is an active Phase 3 open-label extension, and NCT06785454 was a Phase 2 study in obstructive sleep apnea with hypertension.
Yes, lorundrostat Dose 1 is an alternative name used for lorundrostat, so searches for either term refer to the same investigational compound developed by Mineralys Therapeutics for hypertension and obstructive sleep apnea with hypertension.