Drugs / Finerenone
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic kidney disease 1 milestone | |||||
| Filed | Japan (PMDA) | — | chronic kidney disease | 2026-08-28 | “Bayer today announced that it has submitted a marketing authorization application in Japan to expand the use of finerenone in chronic kidney disease (CKD).” bayer.com ↗ |
| Filed diabetic kidney disease 2 milestones | |||||
| Filed | US (FDA) | Kerendia™ | diabetic kidney disease | 2026-05-21 | “has accepted its supplemental New Drug Application (sNDA) and granted Priority Review designation for Kerendia™ (finerenone)” bayer.com ↗ |
| Filed | China (NMPA) | — | diabetic kidney disease | 2021-07-09 | “Finerenone has also been submitted for marketing authorization in China, as well as multiple other countries worldwide” bayer.com ↗ “Finerenone has also been submitted for marketing authorization in the European Union (EU) and in China” bayer.com ↗ “Finerenone has also been submitted for marketing authorization in the European Union (EU) and China” bayer.com ↗ “Finerenone has also been submitted for marketing authorization in China” bayer.com ↗ |
| Filed heart failure 3 milestones | |||||
| Filed | US (FDA) | Kerendia™ | heart failure | 2026-10-08 | “the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for finerenone (Kerendia™)” bayer.com ↗ “FDA has accepted its supplemental New Drug Application (sNDA) and granted Priority Review designation for finerenone” bayer.com ↗ |
| Filed | EU (EMA) | Kerendia™ | heart failure | 2025-02-03 | “Finerenone has also been submitted for marketing authorization in this common form of heart failure in China, the EU” bayer.com ↗ “Finerenone has also been submitted for marketing authorization in HF with an LVEF of ≥40% in China, the EU” bayer.com ↗ “Finerenone has also been submitted for marketing authorization in the European Union (EU)” bayer.com ↗ |
| Filed | China (NMPA) | Kerendia™ | heart failure | — | “Finerenone has also been submitted for marketing authorization in HF with an LVEF of ≥40% in China” bayer.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | KERENDIA | — | 2022-09-01 – 2025-07-11 | fda.gov ↗ |
| Approved | EU (EMA) | Kerendia | — | 2022-02-16 | europa.eu ↗ |
| Approved | US (FDA) | KERENDIA | — | 2021-07-09 | fda.gov ↗ |
Trials 69 · started per year
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EU approved 2022
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT07116512 | May → Jul 2023 | left ventricular failure | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04881994 | Mar → Sep 2014 | advanced heart failure, diabetic kidney disease | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01687920 | Sep → Nov 2012 | heart failure | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04908436 | Oct 2010 → May 2011 | advanced heart failure, chronic kidney disease | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01473108 | Mar → Nov 2010 | — | Bayer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06143566 | Mar 2024 → Sep 2027 expected | hypertensive disorder, type 2 diabetes mellitus | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 216 trials · 2 met primary · 2 missed | ||||||
| Phase 2 | NCT07815509 | Sep 2026 → Dec 2027 expected | primary ovarian failure | The University of Hong Kong-Shenzhen Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07594145 | Sep 2026 → Dec 2029 expected | cardio-renal syndrome, diabetic kidney disease, symptomatic heart failure, type 1 diabetes mellitus | Oregon Health and Science University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07799519 | Jun 2026 → Jun 2028 expected | atrial fibrillation | National Cheng-Kung University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06906081 | May 2025 → Jan 2028 expected | autonomic neuropathy, diabetic neuropathy, type 2 diabetes mellitus | Peter Rossing | Recruiting | No outcome recorded |
| Phase 2 | NCT06835322 | Apr 2025 → Mar 2026 | glomerulonephritis | Alexandria University | Completed | No outcome recorded |
| Phase 2 | NCT06655480 | Mar 2025 → Dec 2027 expected | intrinsic cardiomyopathy, symptomatic heart failure | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation | Recruiting | No outcome recorded |
| Phase 2 | NCT07819227 | Feb 2025 → Aug 2026 | chronic kidney disease | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 2 | NCT06818305 | Jan → Oct 2025 | chronic kidney disease, renal cell carcinoma | Jinling Hospital, China | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06059664 | Apr 2024 → Mar 2027 expected | — | University of North Carolina, Chapel Hill | Recruiting | No outcome recorded |
| Phase 2 | NCT05254002 | Jun 2022 → Mar 2025 | chronic kidney disease, type 2 diabetes mellitus | Bayer | Completed | Met primary |
| Phase 2 | NCT05013008 | Aug → Dec 2021 | chronic kidney disease, type 2 diabetes mellitus | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT01955694 | Nov 2013 → Jan 2015 | heart failure | Bayer | Completed | Missed primary |
| Phase 2 | NCT01968668 | Oct 2013 → Oct 2014 | diabetic kidney disease | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT01807221 | Jun 2013 → Nov 2014 | heart failure | Bayer | Completed | Missed primary |
| Phase 2 | NCT01874431 | Jun 2013 → Jul 2014 | diabetic kidney disease | Bayer | Completed | Met primary |
| Phase 2 | NCT01345656 | May 2011 → May 2012 | heart failure | Bayer | Completed | No outcome recorded |
| Phase 318 trials · 5 met primary | ||||||
| Phase 3 | NCT07575672 | Jul 2026 → Dec 2029 expected | heart failure | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07192952 | Jun 2026 → Dec 2030 expected | left ventricular failure | Bayer | Recruiting | No outcome recorded |
| Phase 3 | NCT07598864 | May 2026 → May 2027 expected | diabetic kidney disease | Chittagong Medical College | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07181135 | Mar 2026 → Dec 2027 expected | chronic kidney disease | University Medical Center Groningen | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT07188805 | Nov 2025 → Nov 2029 expected | left ventricular failure | Bayer | Recruiting | No outcome recorded |
| Phase 3 | NCT07356388 | Jan 2025 → Oct 2027 expected | disease related to solid organ transplantation, proteinuria | kewen Chen,MD | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06580288 | Oct 2024 → Jun 2026 overdue | IgA glomerulonephritis | Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06058585 | Sep 2024 → Dec 2029 expected | chronic kidney disease | The George Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT06033950 | Aug 2024 → Aug 2026 overdue | heart failure | Colorado Prevention Center | Recruiting | No outcome recorded |
| Phase 3 | NCT06024746 | Jul 2024 → Nov 2027 expected | heart failure | Colorado Prevention Center | Recruiting | No outcome recorded |
| Phase 3 | NCT05901831 | Feb 2024 → Aug 2025 | chronic kidney disease, type 1 diabetes mellitus | Bayer | Completed | Met primary |
| Phase 3 | NCT06008197 | Jan 2024 → Nov 2027 expected | heart failure | Colorado Prevention Center | Recruiting | No outcome recorded |
| Phase 3 | NCT05457283 | Nov 2022 → Aug 2028 expected | chronic kidney disease, proteinuria | Bayer | Recruiting | No outcome recorded |
| Phase 3 | NCT05196035 | Mar 2022 → May 2027 expected | chronic kidney disease, proteinuria | Bayer | Recruiting | No outcome recorded |
| Phase 3 | NCT05047263 | Sep 2021 → Dec 2025 | chronic kidney disease | Bayer | Completed | Met primary |
| Phase 3 | NCT04435626 | Sep 2020 → May 2024 | heart failure | Bayer | Completed | Met primary |
| Phase 3 | NCT02545049 | Sep 2015 → Feb 2021 | diabetic kidney disease | Bayer | Completed | Met primary |
| Phase 3 | NCT02540993 | Sep 2015 → Apr 2020 | chronic kidney disease | Bayer | Completed | Met primary |
| Phase 422 trials | ||||||
| Phase 4 | NCT07830940 | Sep 2026 → Sep 2027 expected | heart failure | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07667517 | Jul 2026 → Oct 2027 expected | chronic kidney disease, proteinuria, type 2 diabetes mellitus | First Affiliated Hospital of Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07583173 | May 2026 → Oct 2027 expected | heart failure | China National Center for Cardiovascular Diseases | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07523867 | Apr → Oct 2026 expected | diabetic kidney disease, heart failure | Hospital de Messejana Dr. Carlos Alberto Studart Gomes | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07442448 | Apr 2026 → Dec 2028 expected | heart failure | Cathay General Hospital | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT07397650 | Feb 2026 → Dec 2027 expected | heart failure | Juntendo University | Recruiting | No outcome recorded |
| Phase 4 | NCT07351864 | Jan → Oct 2026 expected | heart failure | Mansoura University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07235891 | Nov 2025 → Dec 2026 expected | chronic kidney disease, retinal nerve fiber layer disorder | Alexandria University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07239570 | Jun 2025 → Jun 2028 expected | chronic kidney disease | Peter Rossing | Recruiting | No outcome recorded |
| Phase 4 | NCT07315191 | Jun 2025 → Oct 2027 expected | immunoglobulin A vasculitis | Capital Institute of Pediatrics, China | Recruiting | No outcome recorded |
| Phase 4 | NCT06727409 | Dec 2024 → Jul 2026 overdue | — | Chinese University of Hong Kong | Recruiting | No outcome recorded |
| Phase 4 | NCT07026539 | Oct 2024 → Dec 2026 expected | cardiovascular disorder, diabetic kidney disease, type 2 diabetes mellitus | University of Aarhus | Recruiting | No outcome recorded |
| Phase 4 | NCT06573411 | Sep 2024 → Oct 2026 expected | membranous glomerulonephritis | First Affiliated Hospital, Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 4 | NCT06094920 | Jul 2024 → Sep 2025 | diabetic kidney disease, proteinuria, type 2 diabetes mellitus | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 4 | NCT06457074 | Jun 2024 → Apr 2026 | primary aldosteronism | Chongqing Medical University | Completed | No outcome recorded |
| Phase 4 | NCT06381323 | Mar 2024 → Jun 2025 | primary aldosteronism | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Completed | No outcome recorded |
| Phase 4 | NCT06164379 | Dec 2023 → Dec 2024 | primary aldosteronism | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT05887817 | Sep 2023 → Feb 2025 overdue | chronic kidney disease, type 2 diabetes mellitus | Saga University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05924620 | Jun 2023 → Mar 2024 | primary aldosteronism | Chongqing Medical University | Completed | No outcome recorded |
| Phase 4 | NCT05814770 | May 2023 → Mar 2025 | hypertensive disorder, primary aldosteronism | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Unknown | No outcome recorded |
| Phase 4 | NCT05688579 | Apr 2023 → Dec 2026 expected | hyperaldosteronism, hypertensive disorder | Nanfang Li | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05705271 | Feb 2023 → Jul 2025 | chronic kidney disease, type 2 diabetes mellitus | Bayer | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT07849348 | Sep 2026 → Feb 2027 expected | chronic kidney disease | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07678151 | Jul 2026 → Apr 2027 expected | hypertensive disorder | Heart Health Research Center | Not yet recruiting | No outcome recorded |
| — | NCT07585526 | Apr 2026 → Mar 2028 expected | chronic kidney disease, metabolic dysfunction-associated steatotic liver disease | Institute of Liver and Biliary Sciences, India | Not yet recruiting | No outcome recorded |
| — | NCT07688928 | Apr 2026 → Mar 2027 expected | primary aldosteronism, secondary hypertension | Bangladesh Medical University | Recruiting | No outcome recorded |
| — | NCT07326631 | Jan → Jun 2026 overdue | diabetic kidney disease, heart failure | College of Physicians and Surgeons Pakistan | Not yet recruiting | No outcome recorded |
| — | NCT07056595 | May 2025 → May 2026 overdue | IgA glomerulonephritis | Botkin Hospital | Recruiting | No outcome recorded |
| — | NCT04795726 | Mar → Jun 2021 | diabetic retinopathy | Bayer | Completed | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT02957396 Comparator | Nov 2016 → Jan 2017 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02956109 Comparator | Nov → Dec 2016 | — | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT05897372 Background | Aug 2023 → Sep 2024 | diabetic kidney disease | Iain Bressendorff | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT07270367 Comparator | Dec 2025 → Dec 2030 expected | heart failure | Subodh Verma | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07223502 Comparator | May 2025 → Sep 2026 | hypertensive disorder | Sarfez Pharmaceuticals, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT06082063 Comparator | Jul 2024 → Jul 2029 expected | heart failure, kidney failure, type 1 diabetes mellitus | Steno Diabetes Center Copenhagen | Recruiting | No outcome recorded |
| Phase 3 | NCT06244758 Comparator | Jan 2024 → Nov 2025 | type 2 diabetes mellitus | University of Erlangen-Nürnberg Medical School | Completed | No outcome recorded |
| Phase 4 | NCT07537088 Background | May 2026 → Apr 2027 expected | chronic kidney disease, type 2 diabetes mellitus | First Affiliated Hospital of Wannan Medical College | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07547878 Comparator | Apr 2026 → Mar 2029 expected | chronic kidney disease, type 2 diabetes mellitus | Baylor Research Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06954090 Comparator | Nov 2025 → Nov 2026 expected | diabetic kidney disease, proteinuria, type 2 diabetes mellitus | Steno Diabetes Center Copenhagen | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT07155694 Comparator | Sep 2025 → Jul 2027 expected | diabetic kidney disease | Washington D.C. Veterans Affairs Medical Center | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 50
| Date | Issuer | Release |
|---|---|---|
| 2026-10-08 | Bayer | Regulatory U.S. FDA accepts Bayer’s supplemental New Drug Application for finerenone in chronic kidney disease without diabetes bayer.com ↗
Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for finerenone (Kerendia™), supporting a potential new indication in adults with chronic kidney disease (CKD) without diabetes. |
| 2026-09-17 | Bayer | Regulatory U.S. FDA approves finerenone for new indication in patients with chronic kidney disease associated with type 1 diabetes bayer.com ↗
Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Kerendia™ (finerenone), a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA), for the treatment of adult patients with chronic kidney disease (CKD) associated with type 1 diabetes (T1D). |
| 2026-08-30 | Bayer | Results Finerenone slowed kidney function decline and reduced kidney-cardiovascular risk versus placebo in patients with hypertensive nephropathy bayer.com ↗
The analysis showed that finerenone (Kerendia™/Firialta™) slowed kidney function decline and reduced kidney-cardiovascular risk compared with placebo, in addition to standard of care, in patients with hypertensive nephropathy. |
| 2026-08-28 | Bayer | Regulatory Bayer submits application in Japan for expanded use of Kerendia in chronic kidney disease therapeutic area bayer.com ↗
Bayer today announced that it has submitted a marketing authorization application in Japan to expand the use of finerenone in chronic kidney disease (CKD). |
| 2026-07-30 | Bayer | Regulatory Bayer submits application for next indication of Kerendia in China bayer.com ↗ |
| 2026-06-05 | Bayer | Results Finerenone significantly reduced the risk of kidney disease progression and cardiovascular outcomes in broad patient populations with CKD bayer.com ↗
Finerenone also significantly reduced the risk of the main composite cardiovascular outcome of heart failure hospitalisation or cardiovascular death by 20% versus placebo |
| 2026-06-05 | Bayer | Results Bayer’s finerenone significantly reduced kidney function decline and a composite of cardiovascular-kidney outcomes versus placebo in patients with non-diabetic chronic kidney disease bayer.com ↗
Finerenone also significantly reduced the key secondary endpoint, a composite of cardiovascular-kidney outcomes by 23% (HR 0.77 [95% CI, 0.60-0.99; p=0.04]) |
| 2026-05-22 | Bayer | Regulatory Kerendia™ approved in China for new indication in adult patients with heart failure with LVEF ≥40% bayer.com ↗
The Chinese National Medical Products Administration granted approval for a label update to extend the indication of Kerendia™ to adult patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40% |
| 2026-05-21 | Bayer | Regulatory U.S. FDA grants Priority Review for finerenone in chronic kidney disease associated with type 1 diabetes bayer.com ↗
Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) and granted Priority Review designation for Kerendia™ (finerenone) for the treatment of chronic kidney disease (CKD) associated with type 1 diabetes (T1D). |
| 2026-03-30 | Bayer | Regulatory Kerendia™ approved in EU for new indication in adult patients with heart failure with LVEF ≥40% bayer.com ↗
In the EU, Kerendia (10mg, 20mg, 40mg) is now indicated for the treatment of symptomatic chronic heart failure with LVEF ≥40% in adults, expanding its use beyond the existing indication in patients with chronic kidney disease associated with type 2 diabetes. |
| 2026-03-16 | Bayer | Results Finerenone meets primary endpoint in pivotal Phase III FIND-CKD study in patients with non-diabetic chronic kidney disease bayer.com ↗
The Phase III study FIND-CKD, evaluating the efficacy and safety of finerenone (Kerendia™) versus placebo when added to standard of care in adult patients with non-diabetic chronic kidney disease (CKD), has met its primary endpoint. |
| 2026-01-30 | Bayer | Regulatory Finerenone recommended for the treatment of patients with heart failure with LVEF ≥40% in the EU bayer.com ↗
CHMP adopts positive opinion for the marketing authorization of finerenone for patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, i.e. mildly reduced or preserved LVEF, in the European Union |
| 2025-12-22 | Bayer | Regulatory Finerenone approved in Japan for treatment of patients with chronic heart failure bayer.com ↗
Bayer today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved finerenone (Kerendia™), a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA), for the treatment of adult patients with chronic heart failure (HF) with left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF). |
| 2025-11-06 | Bayer | Results Bayer's Non-Steroidal MRA showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes bayer.com ↗
Finerenone showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes |
| 2025-07-14 | Bayer | Regulatory U.S. FDA Approves Finerenone for New Indication in Patients with Heart Failure with Left Ventricular Ejection Fraction of ≥ 40% bayer.com ↗
Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved finerenone (Kerendia™), a non-steroidal, selective mineralocorticoid receptor antagonist, for the treatment of adult patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%. |
| 2025-06-05 | Bayer | Results Simultaneous treatment start with Finerenone and SGLT-2-inhibitor demonstrated positive data in patients with CKD associated with type 2 diabetes bayer.com ↗
The CONFIDENCE study showed that simultaneous initiation with finerenone and empagliflozin in patients with CKD associated with T2D led to an early and additive reduction in UACR from baseline of 52% at Day 180. |
| 2025-03-17 | Bayer | Regulatory U.S. FDA grants Priority Review for new indication of finerenone for patients with common form of heart failure bayer.com ↗
Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) and granted Priority Review designation for finerenone for the treatment of adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF). |
| 2025-02-14 | Bayer | Regulatory Bayer files for approval of finerenone in heart failure in Japan bayer.com ↗
Regulatory submission is based on positive data from the Phase III FINEARTS-HF study presented at ESC Congress 2024, and simultaneously published in the New England Journal of Medicine |
| 2025-02-03 | Bayer | Regulatory Bayer files for approval of finerenone in heart failure in the EU bayer.com ↗
Regulatory submission is based on positive data from the Phase III FINEARTS-HF study presented at ESC Congress 2024, and simultaneously published in the New England Journal of Medicine |
| 2025-01-10 | Bayer | Regulatory Bayer submits application to U.S. FDA and to China’s CDE for new indication of finerenone for patients with common form of heart failure with high unmet medical need bayer.com ↗ |
| 2024-09-10 | Bayer | Results New subgroup analysis from FINEARTS-HF revealed patients with heart failure and a left ventricular ejection fraction of ≥40% receiving finerenone had a reduced risk of new-onset diabetes bayer.com ↗
Bayer announced today new late-breaking data showing that patients with heart failure and a left ventricular ejection fraction of ≥40% receiving finerenone (Kerendia™/ Firialta™) had a 24% reduced risk of new-onset diabetes, compared to placebo. |
| 2024-09-01 | Bayer | Results Late-Breaking data from finerenone pooled analysis on cardiovascular and kidney outcomes and mortality in high-risk patient populations presented at ESC Congress 2024 bayer.com ↗
Results also indicate significant reductions of finerenone versus placebo of all-cause death as well as CV and kidney outcomes. |
| 2024-09-01 | Bayer | Results Finerenone showed statistically significant improvement in cardiovascular outcomes in adults with common form of heart failure with high unmet medical need bayer.com ↗
Finerenone showed a 16% relative risk reduction of the composite primary endpoint of cardiovascular death and total (first and recurrent) heart failure events compared to placebo |
| 2024-08-05 | Bayer | Results Finerenone meets primary endpoint in Phase III FINEARTS-HF cardiovascular outcomes study in patients with heart failure with mildly reduced or preserved ejection fraction bayer.com ↗
The results showed that finerenone (Kerendia™) achieved a statistically significant and clinically meaningful reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. |
| 2023-11-02 | Bayer | Results New Kerendia™ (finerenone) data show impact of early albuminuria reduction in patients with chronic kidney disease and type 2 diabetes bayer.com ↗ |
| 2023-05-17 | Bayer | Regulatory Kerendia™ (finerenone) granted expanded indication in China for broad range of patients with chronic kidney disease and type 2 diabetes bayer.com ↗
Bayer announced today that the Chinese National Medical Products Administration (NMPA) granted marketing authorization for a label extension for Kerendia™ (finerenone) to include results on cardiovascular (CV) outcomes from the Phase III FIGARO-DKD study. |
| 2023-02-10 | Bayer | Regulatory Kerendia™ (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes bayer.com ↗
The European Commission granted approval for a label extension for Kerendia™ (finerenone) in the European Union (EU) to include results on cardiovascular (CV) outcomes from the Phase III FIGARO-DKD study. |
| 2022-12-16 | Bayer | Regulatory Finerenone receives positive CHMP opinion for EU-label extension for broad range of patients with chronic kidney disease and type 2 diabetes bayer.com ↗
Bayer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending a label extension for Kerendia™ (finerenone, 10 mg or 20 mg) to include results on cardiovascular outcomes from the Phase III FIGARO-DKD study. |
| 2022-09-02 | Bayer | Regulatory Kerendia™ (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study bayer.com ↗ |
| 2022-08-29 | Bayer | Results New data indicate positive effects of Kerendia™ (finerenone) on mortality in patients with chronic kidney disease and type 2 diabetes bayer.com ↗ |
| 2022-06-30 | Bayer | Regulatory Kerendia™ (finerenone) approved in China for the treatment of adults with chronic kidney disease associated with type 2 diabetes bayer.com ↗
Bayer announced today that the Chinese National Medical Products Administration (NMPA) has granted marketing authorization for finerenone under the brand name Kerendia™. |
| 2022-05-23 | Bayer | Results New data support renal and cardiovascular benefits of Kerendia™ (finerenone) in patients with and without history of left ventricular hypertrophy and chronic kidney disease and type 2 diabetes bayer.com ↗
Data from the exploratory post hoc analysis of FIDELITY also highlight the potential of Kerendia™ (finerenone) to reduce the incidence of hospitalization for heart failure (HHF), with a more pronounced effect in patients with left ventricular hypertrophy (LVH) at baseline |
| 2022-04-04 | Bayer | Results New data for finerenone on the risk reduction of cardiovascular and renal outcomes in patients with a combination of atherosclerotic cardiovascular disease, chronic kidney disease and type 2 diabetes bayer.com ↗
finerenone consistently reduced the risk of the composite CV and kidney outcomes compared with placebo |
| 2022-03-28 | Bayer | Regulatory Bayer receives approval in Japan for Kerendia™ (finerenone), a new treatment for adults with chronic kidney disease and type 2 diabetes bayer.com ↗
Bayer announced today that the Japanese Ministry of Health, Labour, and Welfare (MHLW) has granted marketing authorization for finerenone under the brand name Kerendia™. |
| 2022-03-16 | Bayer | Regulatory Bayer submits application in the EU for an extension of the indication of finerenone to include early stages of chronic kidney disease associated with type 2 diabetes bayer.com ↗
Bayer has submitted a Type II Variation application to the European Medicines Agency (EMA) to seek an extension of the finerenone marketing authorization to include early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D). |
| 2022-02-21 | Bayer | Regulatory Bayer’s new treatment Kerendia® (finerenone) approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes bayer.com ↗
The European Commission has granted marketing authorization in the European Union (EU) for finerenone under the brand name Kerendia®. |
| 2021-12-17 | Bayer | Regulatory Bayer receives positive CHMP opinion for finerenone as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes bayer.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended finerenone, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, for marketing authorization in the European Union (EU). |
| 2021-11-08 | Bayer | Results New data from finerenone clinical trial program reinforces renal and cardiovascular benefits in patients with CKD and T2D independent of baseline therapy bayer.com ↗
Exploratory analysis of the FIGARO-DKD study with finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist, indicated a reduction in renal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), as seen in the FIDELIO-DKD study |
| 2021-08-28 | Bayer | Results New Data on Finerenone for the protection of patients with chronic kidney disease and type 2 diabetes from cardiovascular events and kidney disease progression bayer.com ↗
The findings from the FIGARO-DKD study were presented today during a Hot Line session at ESC Congress 2021, and simultaneously published in the New England Journal of Medicine. |
| 2021-07-09 | Bayer | Regulatory U.S. FDA approves finerenone for the treatment of patients with chronic kidney disease associated with type 2 diabetes bayer.com ↗
Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved finerenone, the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist, under the brand name Kerendia®. |
| 2021-05-17 | Bayer | Results Finerenone has potential to reduce the risk of new onset atrial fibrillation or flutter in patients with chronic kidney disease and type 2 diabetes bayer.com ↗
The analysis also showed that finerenone reduced the risk of the combined primary and the combined key secondary endpoint in the study compared to placebo with no significant difference between patients with and without history of AFF at baseline. |
| 2021-05-10 | Bayer | Results Bayer’s finerenone meets primary endpoint in Phase III FIGARO-DKD cardiovascular outcomes study in patients with chronic kidney disease and type 2 diabetes bayer.com ↗
Finerenone significantly reduced the composite primary endpoint of cardiovascular death and non-fatal cardiovascular events versus placebo when added to standard of care |
| 2021-02-09 | Bayer | Regulatory Bayer submits finerenone for marketing authorization in China for the treatment of chronic kidney disease in type 2 diabetes bayer.com ↗
Bayer today announced the submission of a regulatory application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), seeking approval of finerenone in China for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). |
| 2021-01-12 | Bayer | Regulatory U.S. FDA grants Priority Review to New Drug Application for finerenone to treat patients with chronic kidney disease and type 2 diabetes bayer.com ↗
Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for finerenone to treat patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). |
| 2020-11-17 | Bayer | Results Finerenone showed consistent benefits on cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes with or without history of cardiovascular disease bayer.com ↗
This new subgroup analysis underscores the potential role of finerenone in both primary and secondary CV prevention in these patients. |
| 2020-11-09 | Bayer | Regulatory Bayer submits marketing authorization applications for finerenone in the U.S. and the EU for patients with chronic kidney disease and type 2 diabetes bayer.com ↗
Bayer today announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval of finerenone for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). |
| 2020-10-23 | Bayer | Results Finerenone significantly reduced renal and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes bayer.com ↗
Detailed results from the Phase III FIDELIO-DKD study demonstrated that the investigational drug finerenone slowed the progression of chronic kidney disease (CKD) in patients with CKD and type 2 diabetes (T2D) compared to placebo. |
| 2020-10-12 | Bayer | Results Finerenone Phase III FIDELIO-DKD study in chronic kidney disease and type 2 diabetes to be presented as late-breaking clinical trial at ASN 2020 bayer.com ↗
FIDELIO-DKD met both its composite primary renal endpoint and its composite key secondary cardiovascular endpoint. |
| 2020-07-09 | Bayer | Results Bayer’s finerenone meets primary endpoint in Phase III FIDELIO-DKD renal outcomes study in patients with chronic kidney disease and type 2 diabetes bayer.com ↗
Bayer’s Phase III study FIDELIO-DKD evaluating the efficacy and safety of finerenone versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D)(1) has met its primary endpoint. |
| 2020-07-09 | Bayer | Results Bayer’s finerenone meets primary endpoint in Phase III FIDELIO-DKD renal outcomes study in patients with chronic kidney disease and type 2 diabetes bayer.com ↗
Bayer’s Phase III study FIDELIO-DKD evaluating the efficacy and safety of finerenone versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D)[1] has met its primary endpoint. |
All press releases naming this drug 75 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 85 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | finerenone | “One group was treated with mineralocorticoid receptor antagonists(MRAs) (including spironolactone 20-60mg/ day, or eplerenone50-100mg/day, or finerenone 10-20mg/ day) in...” NCT05688579 ↗76“BACKGROUND: Finerenone (BAY 94-8862) is a potent non-steroidal, selective mineralocorticoid receptor antagonist being developed for the treatment of patients with type 2...” PMID 31583611 ↗ Mar 2020 “The goal of this clinical trial is to learn if Finerenone works to treat proteinuria patients after kidney transplantation.” NCT07356388 ↗ “A combination of finerenone 10 mg, empagliflozin 12.5 mg, and losartan 50 mg or 100 mg within a polycapsule.” NCT06143566 ↗ “Empagliflozin 10mg tablet, Valsartan+Sacubitril 100-200-400 mg tablet, Finerenone 20-40 mg tablet” NCT06655480 ↗ “Drug: Finerenone” NCT07537088 ↗ |
| Known as | BAY94-8862 | “Finerenone (BAY 94-8862) is a potent non-steroidal, selective mineralocorticoid receptor antagonist being developed for the treatment of patients with type 2 diabetes and...” PMID 31583611 ↗ Mar 202033“Finerenone (BAY 94-8862) is a nonsteroidal mineralocorticoid receptor antagonist in development for the treatment of diabetic kidney disease.” PMID 27431783 ↗ Jul 2016 “In this study researchers wanted to learn more about a new substance called finerenone (BAY94-8862).” NCT04881994 ↗ “Finerenone (BAY 94-8862) is a selective, nonsteroidal mineralocorticoid receptor antagonist.” PMID 30825073 ↗ Oct 2019 “BAY 94-8862 is a novel, non-steroidal, mineralocorticoid receptor antagonist” PMID 22562554 ↗ May 2012 “Finerenone (BAY94-8862): 20 mg intact tablet” NCT02957396 ↗ “Drug: Finerenone (Kerendia, BAY94-8862)” NCT05013008 ↗ “Finerenone (BAY94-8862): intervention A” NCT07116512 ↗ “Finerenone (BAY 94-8862) PEG solution” NCT01473108 ↗ “Finerenone (BAY94-8862): 1 0mg tablet” NCT02956109 ↗ “Kerendia (Finerenone, BAY94-8862)” NCT06906081 ↗ |
| Known as | Finerenona | ChEMBL registry synonym — accepted as the source's own label CHEMBL2181927 ↗ |
| Known as | Karendia | “The goal of this clinical trial is to learn if the drug finerenone (Karendia) can improve heart function in participants who are at risk for heart and kidney disease.” NCT07270367 ↗ |
| Known as | Kerendia | “the European Medicines Agency (EMA) has already approved finerenone (Kerendia®) within the EU” NCT06244758 ↗7“Drug: Finerenone (Kerendia, BAY94-8862)” NCT05013008 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT07188805 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT05196035 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT05705271 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT05457283 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT07192952 ↗ “Kerendia (Finerenone, BAY94-8862)” NCT06906081 ↗ |
| Action | Inhibit | “BAY 94-8862 is a novel, non-steroidal, mineralocorticoid receptor antagonist” PMID 22562554 ↗ May 20121“Mineralocorticoid receptor antagonist” CHEMBL2181927 ↗ |
| Modality | Small molecule | “Finerenone (BAY 94-8862) is a potent non-steroidal, selective mineralocorticoid receptor antagonist” PMID 31583611 ↗ Mar 2020 |
| Route | Oral | “BAY94-8862) given orally” NCT01345656 ↗ |
| Target | NR3C2 | “Mineralocorticoid receptor antagonist” CHEMBL2181927 ↗ |