Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 for the treatment of hypertension and renal conditions. It is currently in Phase 2 clinical development for patients with uncontrolled hypertension. The drug is being studied to evaluate its safety and efficacy in this patient population.
MLS-101 is being developed by Mineralys Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol MLYS. The company is conducting clinical trials to evaluate the drug's potential in treating hypertension and renal conditions.
MLS-101 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy for treating hypertension and renal conditions.
MLS-101 has one completed Phase 2 clinical trial registered under NCT05001945. This trial evaluated the safety and efficacy of MLS-101 in patients with uncontrolled hypertension. The study enrolled 200 participants in the United States and was a randomized, double-blind, placebo-controlled trial.
No, MLS-101 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The drug has completed one clinical trial, but it has not yet received regulatory approval and remains under investigation for the treatment of hypertension and renal conditions.