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Also known as MLS-101 (Part I)
MLS-101 · 1 trial · 1 indication
The primary outcome was defined as the change in office-measured (mean of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) SBP from baseline to the end of Study Week 8. The primary efficacy analysis was performed using a mixed model repeated measures (MMRM) approach with defined fixed effects per the statistical analysis plan. A least-square estimate of the mean difference between each dose group and the placebo group is provided for Week 8.
| Arm | Type | Description |
|---|---|---|
| Placebo (Part I) | PLACEBO_COMPARATOR | Placebo tablet(s) by mouth once or twice daily. |
| Dose 1 (Part I) | EXPERIMENTAL | MLS-101 tablet(s) by mouth once or twice daily. |
| Dose 2 (Part I) | EXPERIMENTAL | MLS-101 tablet(s) by mouth once or twice daily. |
| Dose 3 (Part I) | EXPERIMENTAL | MLS-101 tablet(s) by mouth once or twice daily. |
| Placebo (Part II) | PLACEBO_COMPARATOR | Placebo tablet(s) by mouth once daily. |
| Dose (Part II) | EXPERIMENTAL | MLS-101 tablet(s) by mouth once daily. |
| Name | Type | Description |
|---|---|---|
| MLS-101 (Part I) | DRUG | MLS-101 tablet(s) by mouth once or twice daily. |
| Placebo (Part I) | OTHER | Placebo tablet(s) by mouth once or twice daily. |
| Placebo (Part II) | OTHER | Placebo tablet(s) by mouth once daily. |
| MLS-101 (Part II) | DRUG | MLS-101 tablet(s) by mouth once daily. |
Inclusion Criteria: 1. Male and nonpregnant, nonlactating female subjects ≥ 18 years of age. 2. Written informed consent Health Insurance Portability and Accountability Act authorization, and local patient privacy required documentation for this study have been obtained 3. Automated office blood pr...
MLS-101 is an investigational small molecule being developed by Mineralys Therapeutics, Inc. for the treatment of hypertension, including renal hypertension. It is currently at the NDA/BLA stage of development, meaning the company has advanced it beyond clinical trials toward a regulatory filing.
MLS-101 is being developed for hypertension, specifically hypertension in patients with renal involvement. Its clinical program studied adults with uncontrolled hypertension. The drug is an investigational therapy and has not been established as a marketed treatment.
MLS-101 is being developed by Mineralys Therapeutics, Inc., which trades on the Nasdaq under the ticker MLYS. The company sponsors the clinical program for the asset, including the Phase 2 trial conducted in the United States.
MLS-101 is at the NDA/BLA stage, following completion of its clinical trial program. Its single registered trial, NCT05001945, was a completed Phase 2 study. The drug remains investigational and is not described as approved.
MLS-101 has been studied in one registered trial, NCT05001945, titled Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension. It was a completed Phase 2, randomized, double-blind, placebo-controlled study that enrolled 200 adults aged 18 and older in the United States.
Yes. MLS-101 is also referred to as MLS-101 (Part I). Both names refer to the same investigational small molecule developed by Mineralys Therapeutics, Inc. for hypertension, so searches using either name point to the same drug asset and clinical program.