Drug Type Small molecule drug |
Synonyms Finerenone (JAN/USAN/INN), BAY 94-8862, BAY-94-8862 + [5] |
Target |
Action antagonists |
Mechanism MR antagonists(Mineralocorticoid receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (09 Jul 2021), |
RegulationFast Track (United States), Special Review Project (China), Priority Review (United States) |
Molecular FormulaC21H22N4O3 |
InChIKeyBTBHLEZXCOBLCY-QGZVFWFLSA-N |
CAS Registry1050477-31-0 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10633 | Finerenone | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Chronic heart failure | Japan | 22 Dec 2025 | |
| Heart Failure | United States | 14 Jul 2025 | |
| Diabetes Mellitus, Type 2 | Canada | 14 Oct 2022 | |
| Chronic Kidney Diseases | South Korea | 10 May 2022 | |
| Type 2 diabetes mellitus with established diabetic nephropathy | United States | 09 Jul 2021 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Type 1 diabetes mellitus with established diabetic nephropathy | NDA/BLA | United States | 21 May 2026 | |
| Heart failure with normal ejection fraction | Phase 3 | Canada | 01 Dec 2025 | |
| Left ventricular systolic dysfunction | Phase 3 | United States | 19 Nov 2025 | |
| Left ventricular systolic dysfunction | Phase 3 | Argentina | 19 Nov 2025 | |
| Left ventricular systolic dysfunction | Phase 3 | Austria | 19 Nov 2025 | |
| Left ventricular systolic dysfunction | Phase 3 | Belgium | 19 Nov 2025 | |
| Left ventricular systolic dysfunction | Phase 3 | Brazil | 19 Nov 2025 | |
| Left ventricular systolic dysfunction | Phase 3 | Bulgaria | 19 Nov 2025 | |
| Left ventricular systolic dysfunction | Phase 3 | Canada | 19 Nov 2025 | |
| Left ventricular systolic dysfunction | Phase 3 | Czechia | 19 Nov 2025 |
Not Applicable | 6,537 | dkkaoyjoso(vuximcctuf) = pxzsijedtf bahiacbuwe (shbfawkkbp ) View more | Positive | 20 Jun 2026 | |||
Not Applicable | 83 | zybruwhjah(sqiwaplvnw) = ououetdydh iweztcdbqk (yfzykdhfgq ) View more | Positive | 20 Jun 2026 | |||
Phase 3 | 1,584 | Finerenone 10 mg or 20 mg | dmsgqevbom(fsjrdxsqun): Difference = 0.73 (95.0% CI, 0.22 - 1.24) View more | Positive | 05 Jun 2026 | ||
Placebo | |||||||
Phase 2/3 | - | 800 | Empagliflozin/Finerenone combination therapy | syekbvahuf(xderzckdpc) = Combination therapy significantly reduced SBP versus monotherapies in the ≥130 mm Hg (P<0.0001) but not in the <130 mm Hg group. hocmryqjcy (urczmcwvvn ) View more | Positive | 05 Jun 2026 | |
Phase 3 | 1,584 | ymzmqmfmov(vnmjagtyzu) = chhtomnkhb xwyptcllva (fyramntutz, -3.6 to -3.1) View more | Positive | 04 Jun 2026 | |||
Placebo | ymzmqmfmov(vnmjagtyzu) = beseetndim xwyptcllva (fyramntutz, -4.3 to -3.8) View more | ||||||
Phase 3 | 12,990 | mpvmtrjdvo(ywnnwniykj): HR = 1.96 (95.0% CI, 1.43 - 2.69) View more | Positive | 03 Jun 2026 | |||
Placebo | |||||||
Phase 3 | 5,873 | nafirpkruh(bdsldfxshi): RR = 0.77 (95.0% CI, 0.63 - 0.94) View more | Positive | 01 Jun 2026 | |||
Placebo | |||||||
Phase 3 | 6,001 | imqzbfcmet(cywakwybwb) = ibutbvjlhh zdfwzqibps (qmhzsjzdou ) View more | Positive | 24 May 2026 | |||
Phase 3 | 6,001 | butdxrznnx(skfsejaohb): HR = 0.94 (95.0% CI, 0.83 - 1.06) View more | Positive | 19 May 2026 | |||
Placebo | |||||||
Phase 4 | 57 | syrpeuvdpp(qrlwiagvww) = zlcabjoebd htgprhplko (scvdtyjvjk ) View more | Positive | 01 May 2026 |





