finerenone
Trade name: KERENDIA
Small moleculeapprovedFast Track FDA
Approved
Jul 9, 2021
Finerenone, marketed under the brand name Kerendia among others, is a medication used to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes. Finerenone is a non-steroidal mineralocorticoid receptor antagonist. It is taken orally. — Wikipedia
Clinical trial activity
58 trials · 45 clinical orgs · 2 marketing orgs
Phase 1
10
Phase 2
30
Phase 3
17
Phase 4
15
Earliest trial started Mar 1, 2010 (NCT01473108)
Timeline
2010s
2020s
- Jul 9, 2021
Bayer — Earliest FDA Approval
- Jul 9, 2021
Bayer — Marketing Organization
- Jul 9, 2021
Bayer — NDA Secondary Org
- Jul 9, 2021
Bayer — NDA Organization
- May 14, 2026
Macleods Pharmaceuticals, Ltd — Marketing Organization
Indications
Approved for
Studied for
- Albuminuria · Phase 4
- Carcinoma, Renal Cell · Phase 2
- Cardiovascular Diseases · Phase 4
- Child · Phase 3
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Diabetes Complications · Phase 4
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 1 · Phase 3
- Diabetes Mellitus, Type 2 · Phase 4
- Diabetic Nephropathies · Phase 4
- Diabetic Neuropathies · Phase 2
- Drug Therapy · Phase 4
- Glomerulonephritis · Phase 2
- Glomerulonephritis, IGA · Phase 3
- Healthy Volunteers · Phase 1
- Heart Failure · Phase 3
- Hyperaldosteronism · Phase 4
- Hypertension · Phase 4
- Hypertrophy, Left Ventricular · Phase 3
- Kidney Diseases · Phase 4
- Kidney Transplantation · Phase 2
- Mineralocorticoid Receptor Antagonists · Phase 4
- Neoplasms · Phase 1
- Nephrectomy · Phase 2
- Pharmacokinetics · Phase 1
- Pharmacology, Clinical · Phase 1
- Proteinuria · Phase 3
- Renal Insufficiency, Chronic · Phase 4
Mechanism of action
- Mineralocorticoid receptorANTAGONIST
NR3C2 antagonist
Approval history
- approvedPriority reviewFast trackJul 9, 2021
Chemistry & pharmacology
Loading structure…
SMILES
CCOc1ncc(C)c2c1[C@H](c1ccc(C#N)cc1OC)C(C(N)=O)=C(C)N2- Mol. weight
- 378.43 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
First in class
Sources
- WikipediaFinerenone ↗
- ChEMBLCHEMBL2181927 ↗
Also known as
- bay 94-8862
- finerenone
- finerenone
- finerenone
- finerenone
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07192952 | Phase 3 | Jan 5, 2026 | Bayer |
| NCT07270367 | Phase 3 | Dec 31, 2025 | Bayer, Canadian Medical and Surgical Knowledge Translation Research Group |
| NCT07181135 | Phase 3 | Dec 1, 2025 | University of Groningen |
| NCT07223502 | Phase 3 | Dec 1, 2025 | Sarfez Pharmaceuticals, Inc. |
| NCT07188805 | Phase 3 | Nov 28, 2025 | Bayer |
| NCT07235891 | Phase 4 | Nov 20, 2025 | Alexandria University |
| NCT07155694 | Phase 4 | Sep 30, 2025 | Bayer, Department of Veteran Affairs |
| NCT07239570 | Phase 4 | Jun 20, 2025 | INCLIVA, Lund University, Steno Diabetes Center Copenhagen, University of Groningen, University of Hamburg |
| NCT06954090 | Phase 4 | Jun 1, 2025 | Mosaiques Diagnostics GmbH, Steno Diabetes Center Copenhagen |
| NCT07056595 | N/A | May 21, 2025 | Botkin Hospital |
| NCT06906081 | Phase 2 | May 2, 2025 | Aarhus University, Steno Diabetes Center Copenhagen |
| NCT06694480 | Phase 1 | Apr 1, 2025 | Fulgent Pharma LLC. |
| NCT06835322 | Phase 2 | Feb 20, 2025 | Alexandria University |
| NCT06818305 | Phase 2 | Jan 1, 2025 | Jinlin University, Nanjing Medical University, Qingdao University, Shandong University, Xuzhou Medical University |
| NCT06727409 | Phase 4 | Dec 2, 2024 | Chinese University of Hong Kong |
| NCT07026539 | Phase 4 | Oct 23, 2024 | Aarhus University |
| NCT06580288 | Phase 3 | Oct 8, 2024 | Zhejiang University |
| NCT06573411 | Phase 4 | Sep 30, 2024 | Sun Yat-Sen University |
| NCT06033950 | Phase 3 | Jun 30, 2024 | Bayer, Colorado Prevention Center, Saint Luke's Health System |
| NCT06457074 | Phase 4 | Jun 4, 2024 | Changzhi Medical College, Chongqing Medical University, Southwest Medical University, Zhejiang University, Zhengzhou University |
Showing 20 of 58 trials
Page 1 / 3
Organizations
Research & Development (45)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bayer | For profit | 35 | 28 | 5 | 2010 |
| Steno Diabetes Center Copenhagen | Academic/Hospital | 4 | 4 | 3 | 2024 |
| Aarhus University | Academic/Hospital | 3 | 1 | 3 | 2024 |
| Colorado Prevention Center | Academic/Hospital | 3 | 3 | 1 | 2023 |
| Saint Luke's Health System | Academic/Hospital | 3 | 0 | 1 | 2023 |
| University of Groningen | Academic/Hospital | 3 | 2 | 2 | 2024 |
| Alexandria University | Academic/Hospital | 2 | 2 | 2 | 2025 |
| Chongqing Medical University | Academic/Hospital | 2 | 2 | 1 | 2023 |
| Nanjing University | Academic/Hospital | 2 | 2 | 1 | 2023 |
| University of Copenhagen | Academic/Hospital | 2 | 1 | 2 | 2023 |
| Zhejiang University | Academic/Hospital | 2 | 1 | 2 | 2024 |
| Boehringer Ingelheim | For profit | 1 | 0 | 1 | 2024 |
| Botkin Hospital | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Canadian Medical and Surgical Knowledge Translation Research Group | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Changzhi Medical College | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Chinese University of Hong Kong | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Department of Veteran Affairs | Government | 1 | 1 | 1 | 2025 |
| Fulgent Pharma LLC. | For profit | 1 | 1 | 1 | 2025 |
| Herning Hospital | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Hospital of South West Jutland | Academic/Hospital | 1 | 0 | 1 | 2024 |
45 organizations
Page 1 / 3
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bayer | For profit | MKTG | Jul 9, 2021 |
| Bayer | For profit | NDA2 | Jul 9, 2021 |
| Bayer | For profit | NDA | Jul 9, 2021 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | May 14, 2026 |