Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Finerenone: intact · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Adult formulation: Finerenone tablet_Fasting | ACTIVE_COMPARATOR | Single oral dose of 20 mg intact finerenone tablet fasting |
| Adult formulation: Finerenone crushed tablet_Fasting | EXPERIMENTAL | Single oral dose of 20 mg crushed and resuspended finerenone tablet fasting |
| Pediatric formulation: Finerenone suspension_Fasting | EXPERIMENTAL | Single oral dose of 20 mg finerenone suspension fasting |
| Pediatric formulation: Finerenone suspension_Fed | EXPERIMENTAL | Single oral dose of 20 mg finerenone suspension fed; 30 minutes after start of an American breakfast |
| Name | Type | Description |
|---|---|---|
| Finerenone (BAY94-8862): 20 mg intact tablet | DRUG | 20 mg intact finerenone immediate-release tablet; single dose in the fasting condition |
| Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet | DRUG | 20 mg crushed and resuspended finerenone immediate-release tablet; single dose in the fasting condition |
| Finerenone (BAY94-8862): 20 mg suspension | DRUG | 20 mg finerenone suspension; single dose in the fasting condition or in the fed condition |
Inclusion Criteria: * Healthy male subjects * Age: 18 to 45 years (inclusive) * Body mass index (BMI) : ≥ 18 and ≤ 29.9 kg/m² * Race: White Exclusion Criteria: * Subjects with conspicuous findings in medical history and pre-study examination in the opinion of the investigator * A history of relev...
Finerenone is a small molecule being studied for pharmacokinetics, specifically in a pediatric formulation. It is an investigational drug in clinical development and is not approved for any indication. The drug is being developed by Bayer AG.
Finerenone is developed by Bayer AG, a company traded under the ticker BAYRY. The drug is a small molecule currently in Phase 1 clinical development for pharmacokinetic studies.
Finerenone is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for pharmacokinetics in a pediatric formulation.
Finerenone has one completed Phase 1 clinical trial, NCT02957396, which studied a pediatric formulation in healthy male subjects. The trial enrolled 16 participants in Germany and was active-controlled but not double-blinded.
Finerenone is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for pharmacokinetic studies. The drug has completed one clinical trial but has not received regulatory approval.