Numerous clinical trials evaluate finerenone across Phase 1 through Phase 4, including Early Phase 1 and observational studies, focusing on conditions such as chronic kidney disease, type 2 diabetes mellitus, heart failure, primary aldosteronism, and Alport syndrome. Sponsored by pharmaceutical companies like Bayer as well as academic institutions like University Hospital Goettingen, these studies include Phase 3 pediatric heart failure trials and Phase 4 primary aldosteronism evaluations. Across these studies, recruitment statuses range from recruiting and completed to active not recruiting and not yet recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07192952 | RECRUITING | Left Ventricular Systolic Dysfunction; Heart Failure (Pediatric) |
Bayer |
2026-06-01 | PHASE3 |
| NCT07270367 | NOT_YET_RECRUITING | Heart Failure |
Subodh Verma |
2025-12 | PHASE3 |
| NCT07575672 | NOT_YET_RECRUITING | HFpEF - Heart Failure With Preserved Ejection Fraction; TAVI(Transcatheter Aortic Valve Implantation); Finerenone |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2026-07-01 | PHASE3 |
| NCT07594145 | NOT_YET_RECRUITING | Type 1 Diabetes; T1D Heart Failure; Cardio-renal Vascular Function and Failure; Diabetic Chronic Kidney Disease |
Oregon Health and Science University |
2026-11-01 | PHASE2 |
| NCT07188805 | RECRUITING | Left Ventricular Systolic Dysfunction; Heart Failure (Pediatric) |
Bayer |
2025-11-19 | PHASE3 |
| NCT06082063 | RECRUITING | Cardiovascular Diseases; Heart Failure; Type 1 Diabetes; Kidney Failure |
Steno Diabetes Center Copenhagen |
2024-07-01 | PHASE3 |
| NCT07547878 | NOT_YET_RECRUITING | Chronic Kidney Disease; Type 2 Diabetes |
Baylor Research Institute |
2026-04-30 | PHASE4 |
| NCT07775846 | NOT_YET_RECRUITING | Type 2 Diabetic Kidney Disease |
Huijie Zhang |
2026-09-01 | PHASE4 |
| NCT07775482 | NOT_YET_RECRUITING | Acute Kidney Injury; Renal Insufficiency,Chronic; Kidney Diseases |
Jean-Maxime Côté |
2027-01 | |
| NCT07442448 | ENROLLING_BY_INVITATION | Heart Failure and Preserved Ejection Fraction; Heart Failure; Heart Failure and Mildly Reduced Ejection Fraction |
Cathay General Hospital |
2026-04 | PHASE4 |
| NCT05457283 | RECRUITING | Chronic Kidney Disease; Proteinuria; Children |
Bayer |
2022-11-08 | PHASE3 |
| NCT06058585 | RECRUITING | Chronic Kidney Diseases |
The George Institute |
2024-09-04 | PHASE3 |
| NCT07799519 | RECRUITING | Atrial Fibrillation (AF) |
National Cheng-Kung University Hospital |
2026-06-09 | PHASE2 |
| NCT07239570 | RECRUITING | Chronic Kidney Disease(CKD) |
Peter Rossing |
2025-06-20 | PHASE4 |
| NCT07585526 | NOT_YET_RECRUITING | MASLD; Chronic Kidney Diseases |
Institute of Liver and Biliary Sciences, India |
2026-04-15 | |
| NCT06906081 | RECRUITING | Cardiovascular Autonomic Neuropathy; Type 2 Diabetes; Diabetic Neuropathies |
Peter Rossing |
2025-05-02 | PHASE2 |
| NCT07181135 | ENROLLING_BY_INVITATION | Chronic Kidney Disease |
University Medical Center Groningen |
2026-03-13 | PHASE3 |
| NCT07397650 | RECRUITING | Acute Heart Failure |
Juntendo University |
2026-05-11 | PHASE4 |
| NCT06024746 | RECRUITING | Heart Failure |
Colorado Prevention Center |
2024-07-09 | PHASE3 |
| NCT06008197 | RECRUITING | Heart Failure; Acute Heart Failure |
Colorado Prevention Center |
2024-01-17 | PHASE3 |
| NCT07667517 | NOT_YET_RECRUITING | Albuminuria; Type 2 Diabetes Mellitus (T2DM); Chronic Kidney Diseases |
First Affiliated Hospital of Zhejiang University |
2026-07-01 | PHASE4 |
| NCT07583173 | NOT_YET_RECRUITING | Heart Failure |
China National Center for Cardiovascular Diseases |
2026-05-15 | PHASE4 |
| NCT07315191 | RECRUITING | Henoch Schönlein Purpura Nephritis |
Capital Institute of Pediatrics, China |
2025-06-13 | PHASE4 |
| NCT07356388 | ACTIVE_NOT_RECRUITING | Kidney Transplantation Recipients; Proteinuria Patients |
kewen Chen,MD |
2025-01-30 | PHASE3 |
| NCT07155694 | NOT_YET_RECRUITING | Diabetic Kidney Disease |
Washington D.C. Veterans Affairs Medical Center |
2026-10-01 | PHASE4 |
| NCT07598864 | NOT_YET_RECRUITING | Diabetic Nephropathy |
Chittagong Medical College |
2026-05-01 | PHASE3 |
| NCT07678151 | NOT_YET_RECRUITING | Hypertension (HTN) |
Heart Health Research Center |
2026-07-13 | |
| NCT05196035 | ACTIVE_NOT_RECRUITING | Chronic Kidney Disease; Proteinuria |
Bayer |
2022-03-28 | PHASE3 |
| NCT07537088 | NOT_YET_RECRUITING | T2DM (Type 2 Diabetes Mellitus); CKD - Chronic Kidney Disease |
First Affiliated Hospital of Wannan Medical College |
2026-05 | PHASE4 |
| NCT06059664 | RECRUITING | Kidney Transplant; Complications |
University of North Carolina, Chapel Hill |
2024-04-23 | PHASE2 |
| NCT07688928 | RECRUITING | Primary Aldosteronism; Endocrine Hypertension |
Bangladesh Medical University |
2026-04-15 | |
| NCT07026539 | RECRUITING | Type 2 Diabetes Mellitus (T2DM); Chronic Kidney Disease Due to Type 2 Diabetes Mellitus; Cardiovascular Diseases |
University of Aarhus |
2024-10-23 | PHASE4 |
| NCT07235891 | NOT_YET_RECRUITING | Retinal Nerve Fiber Layer Thickness; Chronic Kidney Disease |
Alexandria University |
2025-11-20 | PHASE4 |
| NCT06954090 | ENROLLING_BY_INVITATION | Type 2 DM; Type 2 DM /Diabetic Nephropathy; Albuminuria |
Steno Diabetes Center Copenhagen |
2025-11-20 | PHASE4 |
| NCT06573411 | RECRUITING | Primary Membranous Nephropathy |
First Affiliated Hospital, Sun Yat-Sen University |
2024-09-30 | PHASE4 |
| NCT07523867 | NOT_YET_RECRUITING | Heart Failure; Diabetic Kidney Disease; Hyperkalemia |
Hospital de Messejana Dr. Carlos Alberto Studart Gomes |
2026-04 | PHASE4 |
| NCT06033950 | RECRUITING | Heart Failure |
Colorado Prevention Center |
2024-08-20 | PHASE3 |
| NCT06727409 | RECRUITING | Patients With Type 2 Diabetes |
Chinese University of Hong Kong |
2024-12-12 | PHASE4 |
| NCT07223502 | RECRUITING | Hypertension (HTN) |
Sarfez Pharmaceuticals, Inc. |
2025-12-01 | PHASE3 |
| NCT07326631 | NOT_YET_RECRUITING | Diabetic Kidney Disease (DKD); Heart Failure |
College of Physicians and Surgeons Pakistan |
2026-01-01 | |
| NCT06580288 | NOT_YET_RECRUITING | IgA Nephropathy |
Zhejiang University |
2024-10-08 | PHASE3 |
| NCT07056595 | RECRUITING | IgA Nephropathy (IgAN) |
Botkin Hospital |
2025-05-21 | |
| NCT07351864 | NOT_YET_RECRUITING | Heart Failure |
Mansoura University |
2026-01-18 | PHASE4 |
| NCT06835322 | COMPLETED | Glomerulonephritis |
Alexandria University |
2025-04-01 | PHASE2 |
| NCT05047263 | COMPLETED | Non-diabetic Chronic Kidney Disease |
Bayer |
2021-09-21 | PHASE3 |
| NCT06244758 | COMPLETED | Type2diabetes |
University of Erlangen-Nürnberg Medical School |
2024-01-18 | PHASE3 |
| NCT06818305 | TERMINATED | Renal Cell Carcinoma (Kidney Cancer); Renal Cell Carcinoma (RCC); Nephrectomy; Chronic Kidney Disease(CKD) |
Jinling Hospital, China |
2025-01-01 | PHASE2 |
| NCT06094920 | COMPLETED | Diabetes Mellitus Type 2 With Proteinuria; Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes; Diabetes Complications; Albuminuria; Chronic Kidney Diseases; Chronic Kidney Disease Due to Type 2 Diabetes Mellitus; Chronic Kidney Disease stage3; Chronic Kidney Disease stage4; CKD; CKD Stage 3; CKD Stage 4 |
University Medical Center Groningen |
2024-07-29 | PHASE4 |
| NCT05901831 | COMPLETED | Chronic Kidney Disease; Type 1 Diabetes Mellitus |
Bayer |
2024-02-26 | PHASE3 |
| NCT05705271 | COMPLETED | Chronic Kidney Disease; Type 2 Diabetes Mellitus |
Bayer |
2023-02-08 | PHASE4 |
| NCT06381323 | COMPLETED | Primary Aldosteronism; Finerenone; Mineralocorticoid Receptor Antagonist |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
2024-03-01 | PHASE4 |
| NCT06457074 | UNKNOWN | Primary Aldosteronism |
Qifu Li |
2024-06-04 | PHASE4 |
| NCT05254002 | COMPLETED | Type 2 Diabetes Mellitus; Chronic Kidney Disease |
Bayer |
2022-06-23 | PHASE2 |
| NCT05814770 | UNKNOWN | Primary Aldosteronism; Hypertension |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
2023-05 | PHASE4 |
| NCT05887817 | UNKNOWN | Type 2 Diabetes; Chronic Kidney Diseases |
Saga University |
2023-09-07 | PHASE4 |
| NCT06164379 | UNKNOWN | Primary Aldosteronism |
Shanghai Jiao Tong University School of Medicine |
2023-12-16 | PHASE4 |
| NCT06330974 | Not yet recruiting | Asthma|Asthma in Children|Allergy|Rhinitis Allergic|Atopic Dermatitis|Allergen Immunotherapy |
Tampere University|Professor Lauri Lehtimäki|Professor Mika Mäkelä|Professor Sanna Toppila-Salmi|Professor Ilkka Junttila |
2024-10 | -- |
| NCT05897372 | TERMINATED | Diabetic Kidney Disease |
Iain Bressendorff |
2023-08-01 | PHASE2 |
| NCT06402760 | Not yet recruiting | Psoriasis|Diabetes |
Shanghai Yueyang Integrated Medicine Hospital|Shanghai Hongkou District Center for Disease Control And Prevention |
2024-07-01 | Early Phase 1 |
| NCT04435626 | COMPLETED | Heart Failure |
Bayer |
2020-09-14 | PHASE3 |
| NCT06359418 | Not yet recruiting | Obesity|Pre-diabetes |
Guang''anmen Hospital of China Academy of Chinese Medical Sciences|Hubei Hospital of Traditional Chinese Medicine|The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine|Dongfang Hospital Beijing University of Chinese Medicine|Guangdong Provincial Hospital of Traditional Chinese Medicine|Heilongjiang Academy of traditional Chinese Medicine |
2024-04-10 | Not Applicable |
| NCT05924620 | COMPLETED | Primary Aldosteronism |
Chongqing Medical University |
2023-06-21 | PHASE4 |
| NCT07116512 | COMPLETED | Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent; Healthy Volunteers |
Bayer |
2023-05-02 | PHASE1 |
| NCT05013008 | COMPLETED | Chronic Kidney Disease; Type 2 Diabetes Mellitus |
Bayer |
2021-08-18 | PHASE2 |
| NCT04795726 | COMPLETED | Diabetic Retinopathy |
Bayer |
2021-03-10 | |
| NCT02545049 | COMPLETED | Diabetic Kidney Disease |
Bayer |
2015-09-17 | PHASE3 |
| NCT02540993 | COMPLETED | Chronic Kidney Disease |
Bayer |
2015-09-17 | PHASE3 |
| NCT02957396 | COMPLETED | Pharmacokinetics |
Bayer |
2016-11-17 | PHASE1 |
| NCT02956109 | COMPLETED | Pharmacokinetics |
Bayer |
2016-11-16 | PHASE1 |
| NCT01807221 | COMPLETED | Heart Failure |
Bayer |
2013-06-17 | PHASE2 |
| NCT04881994 | COMPLETED | Worsening Chronic Heart Failure; Diabetic Nephropathy |
Bayer |
2014-03-25 | PHASE1 |
| NCT01874431 | COMPLETED | Diabetic Nephropathies |
Bayer |
2013-06-12 | PHASE2 |
| NCT04908436 | COMPLETED | Worsening Chronic Heart Failure; Chronic Kidney Disease |
Bayer |
2010-10-27 | PHASE1 |
| NCT01473108 | COMPLETED | Clinical Pharmacology |
Bayer |
2010-03-29 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-06-29)
Check the
Finerenone (BAY 94-8862)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Finerenone (BAY 94-8862) Solubility in DMSO
- Finerenone (BAY 94-8862) Stock Solution
- Finerenone (BAY 94-8862) Storage
- Finerenone (BAY 94-8862) Stability
- Finerenone (BAY 94-8862) Molecular Weight
- Finerenone (BAY 94-8862) SMILES
- Finerenone (BAY 94-8862) CAS Number
- Finerenone (BAY 94-8862) Chemical Structure (2D and 3D)
- Finerenone (BAY 94-8862) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.