Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY94-8862 · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| BAY94-8862 (2.5 mg) | EXPERIMENTAL | 2.5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 5 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium |
| BAY94-8862 (5 mg) | EXPERIMENTAL | 5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 10 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium |
| Eplerenone | ACTIVE_COMPARATOR | 25 mg eplerenone every other day, i.e. one 25 mg eplerenone capsule on Day 1, Day 3, Day 5, etc. in the morning, 1 placebo capsule on Day 2, Day 4, Day 6, etc. in the morning, and 1 placebo tablet once daily in the morning, with possible up-titration to 25 mg eplerenone once daily at Visit 6 (Day 30), i.e. one 25 mg eplerenone capsule once daily in the morning and 1 placebo tablet once daily in the morning, and a possible up-titration to 25 mg once daily \[if not performed at Visit 6 (Day 30)\] or to 50 mg once daily \[if up-titrated to 25 mg once daily at Visit 6 (Day 30)\] at Visit 8 (Day 60), based on the value of blood potassium |
| BAY94-8862 (7.5 mg) | EXPERIMENTAL | 7.5 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 15 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium Note: This treatment group may be introduced into the study or not after safety and tolerability of these doses has been assessed by an independent Data Monitoring Committee (DMC) (1st dose recommendation DMC meeting). |
| BAY94-8862 (10 mg) | EXPERIMENTAL | 10 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 20 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium Note: Only in case the above mentioned additional treatment arm (BAY94-8862, 7.5 mg) has been added, a second dose decision meeting of the DMC will take place, Again safety and tolerability of all doses will be assessed by an independent DMC (2nd dose recommendation DMC meeting). Based on this data, none or up to two treatment groups (BAY94-8862, 10 mg and BAY94-8862,15 mg) may be introduced into the study. |
| BAY94-8862 (15 mg) | EXPERIMENTAL | 15 mg BAY94-8862 tablet and placebo capsule once daily in the morning, with possible up-titration to 20 mg once daily at Visit 6 (Day 30), and sham up-titration at Visit 8 (Day 60), based on the value of blood potassium Note: Only in case the above mentioned additional treatment arm (BAY94-8862, 7.5 mg) has been added, a second dose decision meeting of the DMC will take place, Again safety and tolerability of all doses will be assessed by an independent DMC (2nd dose recommendation DMC meeting). Based on this data, none or up to two treatment groups (BAY94-8862, 10 mg and BAY94-8862,15 mg) may be introduced into the study. |
| BAY94-8862 (1.25 mg) | EXPERIMENTAL | - |
| BAY94-8862 (5 mg ) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| BAY 94-8862 (15 mg) | EXPERIMENTAL | - |
| BAY 94-8862 (20 mg) | EXPERIMENTAL | - |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | EXPERIMENTAL | - |
| Arm 4 | EXPERIMENTAL | - |
| Arm 5 | PLACEBO_COMPARATOR | - |
| Arm 6 | ACTIVE_COMPARATOR | - |
| BAY94-8862 (1.25mg) | EXPERIMENTAL | single dose BAY94-8862 IR tablet 1.25mg |
| BAY94-8862 (2.5mg) | EXPERIMENTAL | single dose BAY94-8862 IR tablet 2.5mg |
| BAY94-8862 (5mg) | EXPERIMENTAL | single dose BAY94-8862 IR tablet 5mg |
| BAY94-8862 (7.5mg) | EXPERIMENTAL | single dose BAY94-8862 IR tablet 7.5mg |
| BAY94-8862 (10mg) | EXPERIMENTAL | single dose BAY94-8862 IR tablet 10mg |
| Name | Type | Description |
|---|---|---|
| BAY94-8862 | DRUG | 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets |
| Eplerenone | DRUG | INSPRA 25 and 50 mg tablets (MAH: Pfizer) will be used for eplerenone 25 and 50 mg tablets |
| Placebo | DRUG | matching placebo |
| BAY 94-8862 | DRUG | 15 mg BAY 94-8862 tablet once daily in the morning |
| Spironolactone | DRUG | Part B only: 25 mg spironolactone once daily with up-titration to 50 mg once daily starting at day 15, if serum potassium is less or equal to 4.8 mmol/L, for duration of 4 weeks |
| BAY94-8862 (1.25mg) | DRUG | - |
| BAY94-8862 (2.5mg) | DRUG | - |
| BAY94-8862 (5mg) | DRUG | - |
| BAY94-8862 (7.5mg) | DRUG | - |
| BAY94-8862 (10mg) | DRUG | - |
Inclusion Criteria: * Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous (IV) diuretics at hospital * Subjects with either type 2 DM or moderate CKD Exclusion Criteria: * Acute de-novo heart failure or acute inflammatory heart...
BAY94-8862 is an investigational small molecule being developed for heart failure and diabetic nephropathies. It is in Phase 2 clinical development and has been studied in patients with chronic heart failure, including those with chronic kidney disease, and in patients with type 2 diabetes mellitus and diabetic nephropathy.
BAY94-8862 is being developed by Bayer AG, a German pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The drug is currently in Phase 2 clinical development for heart failure and diabetic nephropathies.
BAY94-8862 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has completed three clinical trials, including two Phase 2 studies and one Phase 1 study, with a total enrollment of 554 participants.
BAY94-8862 has completed three clinical trials. NCT01345656 was a Phase 2 dose-finding trial in chronic heart failure with chronic kidney disease. NCT01687920 was a Phase 1 dose proportionality study. NCT01955694 was a Phase 2b study in worsening chronic heart failure. NCT01968668 was a Phase 2 study in diabetic nephropathy.
BAY94-8862 is also known as finerenone. It is a nonsteroidal mineralocorticoid receptor antagonist being developed by Bayer AG. The drug is in Phase 2 clinical development for heart failure and diabetic nephropathies, and has completed trials in these indications.