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 developed by Bayer AG (ticker BAYRY). It has been studied in Phase 2 clinical trials for diabetic nephropathy and heart failure, including worsening chronic heart failure with left ventricular systolic dysfunction. It is also known as BAY94-8862 (1.25mg) in some references.
BAY94-8862 has been studied in clinical trials for diabetic nephropathies and heart failure. Trial populations included patients with type 2 diabetes mellitus and a clinical diagnosis of diabetic nephropathy, and patients with worsening chronic heart failure and left ventricular systolic dysfunction, with or without chronic kidney disease.
BAY94-8862 is developed by Bayer AG, which trades under the ticker BAYRY. Bayer sponsored the Phase 1 and Phase 2 clinical trials of the compound, including studies conducted in Japan, Germany, and multiple European countries.
BAY94-8862 is in Phase 2 clinical development. It is an investigational small molecule and has not been approved by the FDA. All three completed trials in the program, including the Phase 2 ARTS-DN Japan study, have finished, and no trials are currently active.
BAY94-8862 has been evaluated in completed trials including NCT01968668 (ARTS-DN Japan, Phase 2, 96 patients with diabetic nephropathy), NCT01955694 (Phase 2b, 72 patients with worsening chronic heart failure), NCT01687920 (Phase 1 dose proportionality, 25 healthy male volunteers), and NCT01345656 (Phase 2 dose finding, 457 patients with chronic heart failure and chronic kidney disease).