Finerenone clinical trials
Finerenone is named as an intervention in 34 current clinical trials in our Spain, China, Germany, Canada, Taiwan, Brazil, India, Italy, Poland, Czechia, Mexico, South Korea, Denmark, USA, Sweden, Portugal, UK, Belgium, Austria, Turkey, Israel, Australia, Japan, France, Netherlands, Switzerland and Egypt registers. 20 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Bayer (9). The most-studied condition is Chronic Kidney Disease. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Finerenone is approved
All regulators →Of the three regulators tracked here, the first to approve Finerenone was the US, on 9 Jul 2021. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Finerenone patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Finerenone, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 2 listed patents; the last listed expires 29 Jul 2035 (US RE49826).
- Latest patent on the drug substance itself: 29 Jul 2035 (US RE49826).
- Exclusivity I-998: New indication: to reduce urinary albumin-to-creatinine ratio, which is expected to reduce the risk of sustained estimated glomerular filtr…, until 16 Sep 2029.
- Exclusivity I-970: New indication: to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult pat…, until 11 Jul 2028.
- Exclusivity NS: New strength, until 11 Jul 2028.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Finerenone
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Finerenone works
All drug targets →- Mineralocorticoid receptor antagonist AntagonistTarget: NR3C2 nuclear receptor subfamily 3 group C member 2✓ In ChEMBL and the Guide to Pharmacology
- IgA glomerulonephritisPhase 3
- ProteinuriaPhase 3
- Aortic stenosisPhase 3
- Diabetic kidney diseasePhase 3
- Hypertensive disorderPhase 3
- Left ventricular hypertrophyPhase 3
- Type 1 diabetes mellitusPhase 3
- Congestive heart failurePhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2181927, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8678, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Finerenone
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Finerenone. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Finerenone for treating chronic heart failure with preserved or mildly reduced ejection fraction NICE TA1182 | Recommended | 5 Aug 2026 | Current |
| Finerenone for treating chronic kidney disease in type 2 diabetes NICE TA877 | Optimised | 23 Mar 2023 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Finerenone
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: KerendiaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Finerenone
- ChEMBL
- CHEMBL2181927
- DrugBank
- DB16165
- PubChem CID
- 60150535
- CAS number
- 1050477-31-0
- FDA UNII
- DE2O63YV8R
- Wikidata
- Q21099046
- Wikipedia
- Finerenone
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Finerenone
34 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Finerenone in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Finerenone. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
(21467) A Phase 3, single-arm, open-label extension study to evaluate the safety of finerenone in addition to standard of care, in pediatric heart failure patients, from birth to 18 years of age, with left ventricular systolic dysfunction (LVSD)
2024-519830-22-00 · CTIS ↗ · Cardiovascular Diseases
|
Phase 3 | Ongoing | Bayer AG | Czechia, Germany, Greece + 10 more |
Finerenone across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Finerenone on the HPRA medicines list.
- Kerendia 10 mg Film-coated tabletBayer AG · EU/1/21/1616/001-005
- Kerendia 20 mg Film-coated tabletBayer AG · EU/1/21/1616/006-010
- Kerendia 40 mg film-coated tabletsBayer AG · EU/1/21/1616/011-014
Supply shortages
No entry for Finerenone in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Finerenone
38 conditionsAll 38 conditions
| Condition (as registered) | Trials |
|---|---|
| Chronic Kidney Disease | 8 |
| Heart Failure | 8 |
| Type 2 Diabetes Mellitus | 4 |
| Chronic Kidney Diseases | 3 |
| Left Ventricular Systolic Dysfunction | 2 |
| Heart Failure (Pediatric) | 2 |
| Proteinuria | 2 |
| Acute Heart Failure | 2 |
| Albuminuria | 2 |
| Type 2 Diabetes Mellitus (T2DM) | 2 |
| Cardiovascular Diseases | 2 |
| Children | 1 |
| MASLD | 1 |
| Henoch Schönlein Purpura Nephritis | 1 |
| Type 2 Diabetic Kidney Disease | 1 |
| Premature Ovarian Insufficiency | 1 |
| Primary Membranous Nephropathy | 1 |
| Renal Function | 1 |
| HFpEF - Heart Failure With Preserved Ejection Fraction | 1 |
| TAVI(Transcatheter Aortic Valve Implantation) | 1 |
| Finerenone | 1 |
| Alport Syndrome | 1 |
| Hereditary Kidney Disease | 1 |
| Pediatric Kidney Disease | 1 |
| Thin Basement Membrane Disease | 1 |
| Chronic Kidney Disease(CKD) | 1 |
| Chronic Kidney Disease Due to Type 2 Diabetes Mellitus | 1 |
| Type 1 Diabetes | 1 |
| Kidney Failure | 1 |
| Type 2 DM | 1 |
| Type 2 DM /Diabetic Nephropathy | 1 |
| Type 2 Diabetes | 1 |
| Chronic Kidney Disease (CKD) Stages G2 to G3b | 1 |
| Chronic Heart Failure | 1 |
| Heart Failure and Preserved Ejection Fraction | 1 |
| Heart Failure and Mildly Reduced Ejection Fraction | 1 |
| Atrial Fibrillation (AF) | 1 |
| Retinal Nerve Fiber Layer Thickness | 1 |
Sponsors
lead sponsor per trial+ 8 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Finerenone trials
How many clinical trials are testing Finerenone?
34 current trials in our Spain, China, Germany, Canada, Taiwan, Brazil, India, Italy, Poland, Czechia, Mexico, South Korea, Denmark, USA, Sweden, Portugal, UK, Belgium, Austria, Turkey, Israel, Australia, Japan, France, Netherlands, Switzerland and Egypt registers name Finerenone (also registered as Kerendia, BAY94-8862) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Finerenone trials recruiting patients?
Yes. 20 of the 34 trials are recruiting: 9 with sites in Spain, 5 with sites in China, 7 with sites in Germany, 6 with sites in Canada, 6 with sites in Taiwan, 6 with sites in Brazil, 4 with sites in India, 5 with sites in Italy, 5 with sites in Poland, 5 with sites in Czechia, 4 with sites in Mexico, 5 with sites in South Korea, 4 with sites in Denmark, 4 with sites in USA, 4 with sites in Sweden, 4 with sites in Portugal, 3 with sites in UK, 3 with sites in Belgium, 3 with sites in Austria, 3 with sites in Turkey, 3 with sites in Israel, 3 with sites in Australia, 3 with sites in Japan, 1 with sites in France, 1 with sites in Netherlands and 1 with sites in Switzerland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Finerenone clinical trials?
Bayer (9), Colorado Prevention Center (3), Steno Diabetes Center Copenhagen (2) and The George Institute (1), among 23 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Finerenone licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Finerenone, for example Kerendia 10 mg Film-coated tablet (Bayer AG). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Finerenone shortage?
Not in the lists we track: Finerenone has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Finerenone works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Finerenone works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Finerenone (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.