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Finerenone PEG · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Finerenone (20 mg solution) | EXPERIMENTAL | 3-fold crossover of single dose 20 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
| Finerenone (10 mg solution) | EXPERIMENTAL | 3-fold crossover of single dose 10 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
| Finerenone (5 mg solution) | EXPERIMENTAL | 3-fold crossover of single dose 5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
| Finerenone (20 mg as tablets) | EXPERIMENTAL | 3-fold crossover of single dose 20 mg BAY 94-8862 as 2 x 10 mg tablet, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
| Finerenone (2.5 mg solution) | EXPERIMENTAL | 3-fold crossover of single dose 2.5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo. |
| Name | Type | Description |
|---|---|---|
| Finerenone (BAY 94-8862) PEG solution | DRUG | 2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862 |
| Finerenone (BAY 94-8862) immediate release tablet | DRUG | 20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets |
| Eplerenone (Inspra®) | DRUG | Single oral dose of 50 mg eplerenone |
| Placebo | DRUG | Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step |
Inclusion Criteria: * Healthy male white subjects * 18 to 46 years of age * Body mass index (BMI): 18 - 29.9 kg/m² Exclusion Criteria: * Clinically relevant findings in medical history or in the physical examination * Systolic blood pressure below 100 or above 140 mmHg * Diastolic blood pressure ...
Finerenone PEG is an investigational small molecule being developed by Bayer AG for clinical pharmacology studies. It is currently in Phase 1 development. The drug has been studied in a completed clinical trial involving 67 healthy male volunteers in Germany.
Finerenone PEG is being studied for clinical pharmacology purposes, specifically to investigate its natriuretic effects, safety, tolerability, and pharmacokinetics. It is not approved for any specific disease indication and remains in early-stage clinical development.
Finerenone PEG is developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. The company is conducting clinical research on this investigational small molecule.
Finerenone PEG is in Phase 1 clinical development. It has completed one Phase 1 trial, and there are no active trials currently listed. The drug is investigational and has not been approved by regulatory authorities.
Finerenone PEG has one completed clinical trial, NCT01473108, titled 'Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862'. This Phase 1 study enrolled 67 healthy male volunteers aged 18 years and older in Germany.
Yes, Finerenone PEG is also known as BAY94-8862. The clinical trial NCT01473108 refers to the drug as BAY94-8862, confirming that these names refer to the same investigational compound.