Drugs / Finerenone
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 64 · started per year
today
US approved 2021
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 213 trials | ||||||
| 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 | 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 | NCT06818305 | Jan → Oct 2025 | chronic kidney disease, renal cell carcinoma | Jinling Hospital, China | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT01874431 | Jun 2013 → Jul 2014 | diabetic kidney disease | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT01345656 | May 2011 → May 2012 | heart failure | Bayer | Completed | No outcome recorded |
| Phase 318 trials | ||||||
| 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 → Aug 2028 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 → Jul 2026 overdue | 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 | No outcome recorded |
| Phase 3 | NCT06008197 | Jan 2024 → Nov 2027 expected | heart failure | Colorado Prevention Center | Recruiting | No outcome recorded |
| Phase 3 | NCT05457283 | Nov 2022 → Nov 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 | No outcome recorded |
| Phase 3 | NCT04435626 | Sep 2020 → May 2024 | heart failure | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT02540993 | Sep 2015 → Apr 2020 | chronic kidney disease | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT02545049 | Sep 2015 → Feb 2021 | diabetic kidney disease | Bayer | Completed | No outcome recorded |
| Phase 421 trials | ||||||
| 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 | NCT07442448 | Apr 2026 → Dec 2028 expected | heart failure | Cathay General Hospital | Enrolling by invitation | 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 | NCT07397650 | Feb 2026 → Dec 2027 expected | heart failure | Juntendo University | Recruiting | No outcome recorded |
| Phase 4 | NCT07351864 | Jan → Apr 2026 overdue | heart failure | Mansoura University | Not yet 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 → Jun 2025 overdue | primary aldosteronism | Qifu Li | Recruiting | 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 applicable6 trials | ||||||
| — | NCT07678151 | Jul 2026 → Apr 2027 expected | hypertensive disorder | Heart Health Research Center | Not yet recruiting | No outcome recorded |
| — | NCT07688928 | Apr 2026 → Mar 2027 expected | primary aldosteronism, secondary hypertension | Bangladesh Medical University | 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 |
| — | 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 |
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 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 21 trial | ||||||
| Phase 2 | NCT05897372 Background | Aug 2023 → Sep 2024 | diabetic kidney disease | Iain Bressendorff | Terminated | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07223502 Comparator | Dec 2025 → Jul 2026 overdue | hypertensive disorder | Sarfez Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07270367 Comparator | Dec 2025 → Dec 2030 expected | heart failure | Subodh Verma | Not yet recruiting | No outcome recorded |
| 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 44 trials | ||||||
| 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 |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 80 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 ↗71“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 202032“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 ↗ “Finerenone (BAY94-8862): intervention A” NCT07116512 ↗ “Drug: Finerenone (Kerendia, BAY94-8862)” NCT05013008 ↗ “Finerenone (BAY 94-8862) PEG solution” NCT01473108 ↗ “Finerenone (BAY94-8862): 1 0mg tablet” NCT02956109 ↗ “Kerendia (Finerenone, BAY94-8862)” NCT06906081 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT07188805 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT05196035 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT07192952 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT05705271 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT05457283 ↗ “Finerenone (BAY94-8862 ) 10 mg” NCT05254002 ↗ “Finerenone (BAY 94-8862)” NCT07667517 ↗ “Finerenone (BAY 94-8862)” NCT07026539 ↗ “Finerenone (BAY 94-8862)” NCT07181135 ↗ “Finerenone (BAY 94-8862)” NCT06818305 ↗ “Finerenone (BAY94-8862)” NCT04435626 ↗ “Finerenone (BAY94-8862)” NCT05047263 ↗ “Finerenone (BAY94-8862)” NCT02540993 ↗ “Finerenone (BAY94-8862)” NCT01874431 ↗ “Finerenone (BAY94-8862)” NCT04908436 ↗ “Finerenone (BAY94-8862)” NCT04795726 ↗ “Finerenone (BAY94-8862)” NCT02545049 ↗ “Finerenone (BAY94-8862)” NCT01807221 ↗ |
| 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 ↗ “Kerendia (Finerenone, BAY94-8862)” NCT06906081 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT07188805 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT05196035 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT05457283 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT07192952 ↗ “Finerenone (Kerendia, BAY94-8862)” NCT05705271 ↗ |
| 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 ↗ |