Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RGLS8429 · 2 trials · 4 indications
Incidence of adverse events over time
Change from baseline in PC1, PC2, NGAL, and KIM-1 urine biomarkers
Incidence and severity of adverse events after administration of RGLS8429
| Arm | Type | Description |
|---|---|---|
| RGLS8429 | EXPERIMENTAL | The randomized,double blind part of the study (Part A) will consist of three sequential cohorts of approximately 12 subjects each randomized centrally to receive RGLS8429 or placebo by subcutaneous injection every other week (Q2W) x 7 doses (36 subjects total). * Cohort 1: first dose level of RGLS8429 or placebo * Cohort 2: second dose level of RGLS8429 or placebo * Cohort 3: third dose level of RGLS8429 or placebo |
| Placebo | EXPERIMENTAL | The randomized double blind part of the study (Part A) will consist of three sequential cohorts of approximately 12 subjects each randomized centrally to receive RGLS8429 or placebo by subcutaneous injection every other week (Q2W) x 7 doses (36 subjects total). * Cohort 1: first dose level of RGLS8429 or placebo * Cohort 2: second dose level of RGLS8429 or placebo * Cohort 3: third dose level of RGLS8429 or placebo |
| Open Label Fixed Dose RGLS8429 | EXPERIMENTAL | The open-label fixed dose part of the study (Part B and Cohort 4) will consist of a single cohort of up to 30 subjects each receiving 300 mg RGLS8429. |
| RGLS8429, first dose level | EXPERIMENTAL | Eligible participants will receive subcutaneous injection of the first dose level RGLS8429 or placebo |
| RGLS8429, second dose level | EXPERIMENTAL | Eligible participants will receive subcutaneous injection of the second dose level RGLS8429 or placebo |
| RGLS8429, third dose level | EXPERIMENTAL | Eligible participants will receive subcutaneous injection of the third dose level RGLS8429 or placebo |
| RGLS8429, fourth dose level | EXPERIMENTAL | Eligible participants will receive subcutaneous injection of the fourth dose level RGLS8429 or placebo |
| Name | Type | Description |
|---|---|---|
| RGLS8429 | DRUG | Solution for subcutaneous injection |
| Placebo | DRUG | Solution for subcutaneous injection |
| Placebo volume-matching RGLS8429 dose | DRUG | solution for subcutaneous injection |
Key Inclusion Criteria: 1. Male or female ADPKD patients, 18 to 70 years old 2. Class 1C, 1D, or 1E Mayo Imaging Classification of ADPKD (based upon either the MRI obtained during screening, or a prior MRI obtained within 5 years of screening with documented Mayo classification) 3. eGFR between 30 ...
RGLS8429 is an investigational small molecule being studied for Autosomal Dominant Polycystic Kidney Disease (ADPKD), a genetic disorder characterized by cyst growth in the kidneys. It has also been evaluated in healthy volunteers to assess its safety and tolerability. The drug is in Phase 1 clinical development and is not yet approved.
RGLS8429 is being developed by Regulus Therapeutics Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol RGLS. The company is conducting clinical trials of RGLS8429 in the United States for Autosomal Dominant Polycystic Kidney Disease and in healthy volunteers.
RGLS8429 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one in healthy volunteers and one in patients with Autosomal Dominant Polycystic Kidney Disease. The drug is investigational and has not been approved by regulatory authorities.
RGLS8429 has been studied in two completed Phase 1 trials. NCT05429073 evaluated the drug in 32 healthy volunteers in the United States. NCT05521191 evaluated the drug in 68 patients with Autosomal Dominant Polycystic Kidney Disease, also in the United States. Both trials were randomized, double-blind, and controlled.
RGLS8429 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is a small molecule being developed by Regulus Therapeutics Inc. for the treatment of Autosomal Dominant Polycystic Kidney Disease.