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Also known as Finerenone (BAY 94-8862) PEG solution
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 a PEG-based oral solution formulation of finerenone, a small molecule drug candidate developed by Bayer AG. It was studied in a Phase 1 clinical pharmacology trial evaluating natriuretic effects, safety, tolerability, and pharmacokinetics. The trial enrolled 67 healthy male volunteers in Germany.
Finerenone PEG targets NR3C2, the mineralocorticoid receptor, and acts as an antagonist. By blocking this receptor, the drug is designed to modulate sodium and fluid regulation. This mechanism underlies its investigation for natriuretic effects in the Phase 1 study.
Finerenone PEG is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the Phase 1 clinical pharmacology study of this formulation.
Finerenone PEG is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single Phase 1 trial has been completed, and no active trials are currently listed.
Finerenone PEG was studied in one completed Phase 1 trial, NCT01473108, titled "Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862." It was a randomized, controlled trial that enrolled 67 healthy male volunteers in Germany.
Yes, Finerenone PEG is also known as Finerenone (BAY 94-8862) PEG solution. BAY 94-8862 is the compound code for finerenone, and the PEG solution refers to this specific formulation studied in the Phase 1 trial.