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 drug developed by Bayer AG. The clinical program described here evaluated a pediatric formulation of finerenone in healthy male subjects to investigate its pharmacokinetics, meaning how the body absorbs, distributes, and clears the drug. This specific study was not conducted in patients with a disease indication.
Finerenone is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the Phase 1 pharmacokinetic study of a pediatric finerenone formulation conducted in Germany.
The finerenone program described here is in Phase 1. The single listed trial, NCT02957396, is a completed Phase 1 study, so this asset remains in clinical development and is investigational rather than approved for the pharmacokinetic evaluation described.
Finerenone has been studied in NCT02957396, titled Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects. This completed Phase 1 trial enrolled 16 healthy male volunteers aged 18 years and older in Germany, used an active-controlled design, and was not blinded.
Yes. Finerenone is also known as BAY94-8862, and the 20 mg intact tablet is one specific formulation referenced under that name. Searches for BAY94-8862 refer to the same small molecule developed by Bayer AG.
The completed Phase 1 study NCT02957396 investigated a pediatric formulation of finerenone in healthy male subjects to characterize pharmacokinetics, which describes how the drug is absorbed, distributed, metabolized, and eliminated. It enrolled 16 participants in Germany, used an active control, and was not double blinded.