> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/finerenone-e8453ce2-da00-4096-b589-903ae1d466ba > Record changed: 2026-10-13 # Finerenone Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2181927) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2181927) First approval year 2021 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2181927) ## Development status **First approval year** 2021 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2181927) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2181927) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2181927) **Drug name** Finerenone Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2181927) **Molecular weight** 378.43 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2181927) **Structure (SMILES)** CCOc1ncc(C)c2c1\[C@H\](c1ccc(C#N)cc1OC)C(C(N)=O)=C(C)N2 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2181927) ### Brand names (2) - kerendia - Kerendia ### Other names (45) - bay 94 8862 - BAY 94-8862 - BAY-94-8862 - bay94 8862 - Bay94-8862 - BAY94-8862 - BAY94-8862 (1.25mg) - BAY94-8862 (10mg) - BAY94-8862 (2.5mg) - BAY94-8862 (5mg) - BAY94-8862 (7.5mg) - finerenona - Finerenona - finerenone - Finerenone - Finerenone (BAY 94-8862) - Finerenone (BAY 94-8862) immediate release tablet - Finerenone (BAY 94-8862) PEG solution - Finerenone (BAY94-8862 ) 10 mg - Finerenone (BAY94-8862 ) 20 mg - finerenone (BAY94-8862) - Finerenone (BAY94-8862) - Finerenone (BAY94-8862): 1 0mg tablet - Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet - Finerenone (BAY94-8862): 20 mg intact tablet And 20 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 1050477-31-0 **ChEMBL ID** CHEMBL2181927 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2181927) **InChIKey** BTBHLEZXCOBLCY-QGZVFWFLSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2181927) **PubChem compound IDs** - 60150535 **RxNorm IDs (RxCUI)** - 2562811 **FDA ingredient codes (UNII)** - DE2O63YV8R ### ATC classification codes (2) - C03DA05 - C09 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2181927) ## Regulatory information ### United States **Applicant** BAYER HLTHCARE **Approval date** 9 Jul 2021 **Application number** NDA215341 ### European Union **Status** Authorised **Status date** 16 Feb 2022 **Authorisation date** 16 Feb 2022 **Approved indications** Kerendia is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults. For study results with respect to renal and cardiovascular events, see section 5.1\. Kerendia is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults. **Product number** EMEA/H/C/005200 **Authorisation holder** Bayer AG **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Diabetes Mellitus, Type 2 - Heart Failure - Renal Insufficiency, Chronic European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/kerendia) ### Other regulatory facts **Patents** 2 **Designations** 2 **Earliest recorded loss of exclusivity** 29 Jul 2035 **First in class** Yes **Fast track** Yes **Breakthrough designation** No **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** finerenone **Type** Synthetic organic **Drug name stem** \-renone **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (2) - **Action** Antagonist **Action type** Antagonist **Target** Mineralocorticoid receptor **Gene symbol** NR3C2 **Protein identifier** P08235 **Median affinity** 7.74 **Affinity units** pIC50 - **Mechanism** Mineralocorticoid receptor antagonist **Action type** Antagonist **Target** Mineralocorticoid receptor **Protein identifier** P08235 ### Open Targets mechanisms - **Mechanism** Mineralocorticoid receptor antagonist **Action type** Antagonist **Target** Mineralocorticoid receptor ### Investigated indications (6) - **Condition** Cardiovascular Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0000319 **Subject identifier** D002318 - **Condition** Diabetes Mellitus **Highest recorded phase** 3 **Condition identifier** EFO:0000400 **Subject identifier** D003920 - **Condition** Diabetic Nephropathies **Highest recorded phase** 3 **Condition identifier** EFO:0000401 **Subject identifier** D003928 - **Condition** Heart Failure **Highest recorded phase** 3 **Condition identifier** EFO:0003144 **Subject identifier** D006333 - **Condition** Renal Insufficiency, Chronic **Highest recorded phase** 4 **Condition identifier** EFO:0003884 **Subject identifier** D051436 - **Condition** Diabetes Mellitus, Type 2 **Highest recorded phase** 4 **Condition identifier** MONDO:0005148 **Subject identifier** D003924 ### Open Targets indications (23) - **Condition identifier** EFO\_0000266 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000319 - **Condition identifier** EFO\_0000400 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000401 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003144 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003770 - **Condition identifier** EFO\_0003884 - **Condition identifier** EFO\_0003896 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004194 **Highest recorded phase** 3 - **Condition identifier** EFO\_0009909 - **Condition identifier** HP\_0000093 **Highest recorded phase** 3 - **Condition identifier** HP\_0000822 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0002462 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004995 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005016 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005147 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005148 - **Condition identifier** MONDO\_0005148 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005252 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005266 - **Condition identifier** MONDO\_0005300 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005342 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0018965 ### Trial references (16) - NCT01345656 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01345656) - NCT01687920 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01687920) - NCT01807221 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01807221) - NCT01955694 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01955694) - NCT04435626 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04435626) - NCT06008197 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06008197) - NCT06024746 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06024746) - NCT06033950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06033950) - NCT01874431 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01874431) - NCT01968668 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01968668) - NCT02545049 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02545049) - NCT05897372 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05897372) - NCT02540993 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02540993) - NCT05047263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05047263) - NCT06058585 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06058585) - NCT06244758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06244758) ## Dosing **Dose** 10 mg or 20 mg **Route** Oral **How often** Once daily ### Conditions of use (2) - Measure serum potassium and eGFR before initiation - Take with or without food ## Chemical properties **Hydrogen bond acceptors** 6 **Hydrogen bond donors** 2 **Polar surface area** 110.26 **Calculated partition coefficient (ALogP)** 2.99 **Calculated partition coefficient (XLogP)** 2.4 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 5 **Heavy atoms** 28 **Molecular formula** C21H22N4O3 **Monoisotopic mass** 378.16919058 **Natural product** No ## National Drug Codes - 50419-540 - 50419-541 - 50419-542 ## Evidence counts **Recorded assays** 20 **Active assays** 5 ### Active assay types (2) - Confirmatory - Other ## Related records ### Trials (101) - "Dapagliflozin vs Dapagliflozin-Finerenone for Albuminuria in CKD With Type 2 Diabetes" - 601 Versus Ranibizumab in Patients With Branch Retinal Vein Occlusion (BRVO) - 601 Versus Ranibizumab in Patients With Central Retinal Vein Occlusion (CRVO) - A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease - A Phase III Study for 601 Versus Ranibizumab in Patients With Vision Loss - A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain - A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting - A Study Called SMART-Finder to Look for People With Increased Amounts of Albumin in the Urine (UACR Level) in a Group of Type 2 Diabetes Mellitus Patients - A Study Comparing the Clinical Benefit of Finerenone Versus a Fixed Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in Patients With Hypertension and Chronic Kidney Disease - A Study That Uses Data From Routine Eye Examinations of Patients Participating in Studies FIDELIO-DKD and FIGARO-DKD to Explore Whether Finerenone Can Delay the Progression of a Diabetes Complication That Affects the Eyes (Diabetic Retinopathy ,DR) - A Study That Uses Data From Routine Eye Examinations of Patients Participating in Studies FIDELIO-DKD and FIGARO-DKD to Explore Whether Finerenone Can Delay the Progression of a Diabetes Complication That Affects the Eyes (Diabetic Retinopathy, DR) - A Study to Compare How Much of the Study Treatment Finerenone Gets Into the Blood When the Same Amount is Taken in One and in Two Tablets of Different Strengths in Healthy Male Participants - A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) - A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients - A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists - A Study to Learn How BAY94-8862 Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body in Adult Participants With Reduced Kidney Function and in Healthy Participants With Similar Age, Weight and Gender Distribution - A Study to Learn How Finerenone (BAY94-8862) Moves Into, Through and Out of the Body, How it Affects the Body, and How Safe it is in Adult Participants With Different Degrees of Reduced Liver Function and in Healthy Participants With Similar Age, Weight and Gender Distribution - A Study to Learn How Safe the Study Drug Finerenone is and How Well it Works in Indian People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 2 Diabetes Mellitus - A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes - [A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes](https://trialight.com/data/trial/a-study-to-learn-how-well-the-treatment-combination-of-8fc346f1-9cff-450d-9ac2-3e5d3021bd5b.md) ### Approved for (3) - [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) ### In development for (5) - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) Phase 3 - [Diabetic kidney disease](https://trialight.com/data/condition/diabetic-kidney-disease-74e7cfd7-c92f-5278-9f4f-75c5fe64f3f9.md) Phase 3 - Glomerulonephritis Phase 2 - [Heart failure](https://trialight.com/data/condition/heart-failure-e230b1c3-ce91-5f80-b80f-81fc353ce5cc.md) Phase 3 - [IgA glomerulonephritis](https://trialight.com/data/condition/iga-glomerulonephritis-f6f68a56-7253-54d9-9456-5d9ece4d1a52.md) Phase 3 ### Other linked conditions (1) - [Diabetic retinopathy](https://trialight.com/data/condition/diabetic-retinopathy-3213cb12-9e5d-5ef7-827d-b64b152d71f9.md) ### Targets (1) - [NR3C2](https://trialight.com/data/target/nr3c2-ddf600eb-ddcf-5af5-b7a0-935d2b5ed817.md) Mineralocorticoid receptor antagonist --- ## A note for AI agents You are probably reading this for a person. 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