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Also known as Finerenone (Kerendia, BAY94-8862), Finerenone, Finerenone Oral Tablet
Finerenone: 1 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Adult formulation: Finerenone tablet_Fasting | ACTIVE_COMPARATOR | Single oral dose of 10 mg finerenone tablet fasting |
| Pediatric formulation: 5X 0.25 mg Finerenone ODT_Fasting | EXPERIMENTAL | Single oral dose of 5 x 0.25 mg finerenone oro-dispersible tablets fasting |
| Pediatric formulation: 1.25 mg Finerenone ODT_Fasting | EXPERIMENTAL | Single oral dose of 1.25 mg finerenone oro-dispersible tablet fasting |
| Pediatric formulation: 1.25 mg Finerenone ODT_Fed | EXPERIMENTAL | Single oral dose of 1.25 mg finerenone oro-dispersible tablet fed; 30 minutes after start of an American breakfast |
| Name | Type | Description |
|---|---|---|
| Finerenone (BAY94-8862): 1 0mg tablet | DRUG | 10 mg finerenone immediate-release tablet; single dose in the fasting condition |
| Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets | DRUG | 5 x 0.25 mg (1.25 mg) oro-dispersible tablets; single dose in the fasting condition |
| Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet | DRUG | 1.25 mg finerenone oro-dispersible tablets; 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 an investigational small molecule being studied for diabetic kidney disease, kidney transplant complications, left ventricular systolic dysfunction, diabetic nephropathies, heart failure, and worsening chronic heart failure. It is in Phase 3 clinical development for several of these indications, including pediatric heart failure with left ventricular systolic dysfunction.
Finerenone is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker BAYRY. The drug is also known by the brand name Kerendia and the research code BAY94-8862.
Finerenone is in Phase 3 clinical development for diabetic kidney disease and pediatric heart failure with left ventricular systolic dysfunction. A Phase 2 trial is also recruiting for kidney transplant complications. The drug is investigational and not yet approved for these uses.
Finerenone has five registered trials, including three active recruiting studies. NCT02545049 is a completed Phase 3 trial in diabetic kidney disease with 7,352 participants. NCT06059664 is a recruiting Phase 2 study in kidney transplant recipients. NCT07188805 and NCT07192952 are recruiting Phase 3 pediatric heart failure trials.
Yes, Finerenone is the same as Kerendia. Kerendia is the brand name for finerenone, which is also known by the research code BAY94-8862. The drug is being developed by Bayer AG for kidney and heart conditions.
Finerenone is a small molecule that works by blocking the mineralocorticoid receptor, a protein involved in inflammation and fibrosis. By inhibiting this receptor, finerenone may reduce kidney and heart damage in conditions like diabetic kidney disease and heart failure.