Finerenone
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2021
- First approval year
- 2021
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Finerenone
- Molecular weight
- 378.43
- Structure (SMILES)
- CCOc1ncc(C)c2c1[C@H](c1ccc(C#N)cc1OC)C(C(N)=O)=C(C)N2
- kerendia
- Kerendia
- 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.
- CAS registry numbers
- 1050477-31-0
- ChEMBL ID
- CHEMBL2181927
- InChIKey
- BTBHLEZXCOBLCY-QGZVFWFLSA-N
- PubChem compound IDs
- 60150535
- RxNorm IDs (RxCUI)
- 2562811
- FDA ingredient codes (UNII)
- DE2O63YV8R
- C03DA05
- C09
Sources for recorded values
- Applicant
- BAYER HLTHCARE
- Approval date
- 9 Jul 2021
- Application number
- NDA215341
- 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
- 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 name
- finerenone
- Type
- Synthetic organic
- Drug name stem
- -renone
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- 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
- 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
- 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
- NCT01345656
- NCT01687920
- NCT01807221
- NCT01955694
- NCT04435626
- NCT06008197
- NCT06024746
- NCT06033950
- NCT01874431
- NCT01968668
- NCT02545049
- NCT05897372
- NCT02540993
- NCT05047263
- NCT06058585
- NCT06244758
- Dose
- 10 mg or 20 mg
- Route
- Oral
- How often
- Once daily
- Measure serum potassium and eGFR before initiation
- Take with or without food
- 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
- 50419-540
- 50419-541
- 50419-542
- Recorded assays
- 20
- Active assays
- 5
- 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
Approved for (3)
In development for (5)
- Diabetes mellitus Phase 3
- Diabetic kidney disease Phase 3
- Glomerulonephritis Phase 2
- Heart failure Phase 3
- IgA glomerulonephritis Phase 3
Other linked conditions (1)
Targets (1)
- NR3C2 Mineralocorticoid receptor antagonist