Kerendia(finerenone)
Kerendia (finerenone) is a small molecule pharmaceutical. Finerenone was first approved as Kerendia on 2021-07-09. It has been approved in Europe to treat chronic renal insufficiency and type 2 diabetes mellitus. It is known to target mineralocorticoid receptor.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
urogenital diseases | D000091642 |
nutritional and metabolic diseases | D009750 |
endocrine system diseases | D004700 |
signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Kerendia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Finerenone
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
KERENDIA | Bayer | N-215341 RX | 2021-07-09 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
kerendia | New Drug Application | 2021-07-09 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
FINERENONE, KERENDIA, BAYER HLTHCARE | |||
2026-07-09 | NCE | ||
2025-09-01 | M-279 |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Finerenone, Kerendia, Bayer Hlthcare | |||
8436180 | 2029-04-12 | DS, DP |
HCPCS
No data
Clinical
Clinical Trials
31 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Chronic renal insufficiency | D051436 | N18 | 1 | 2 | 3 | 1 | 5 | 12 | |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | — | 1 | 5 | 8 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Heart failure | D006333 | EFO_0003144 | I50 | 3 | 3 | 1 | — | — | 7 |
Diabetic nephropathies | D003928 | EFO_0000401 | 1 | 2 | 1 | — | — | 4 | |
Proteinuria | D011507 | HP_0000093 | R80 | — | — | 2 | — | — | 2 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pharmacokinetics | D010599 | 2 | — | — | — | — | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | — | 2 | 2 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | FINERENONE |
INN | finerenone |
Description | Finerenone, sold under the brand name Kerendia, 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 (MRA).
|
Classification | Small molecule |
Drug class | aldosterone antagonists (spironolactone type) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CCOc1ncc(C)c2c1[C@H](c1ccc(C#N)cc1OC)C(C(N)=O)=C(C)N2 |
Identifiers
PDB | — |
CAS-ID | 1050477-31-0 |
RxCUI | — |
ChEMBL ID | CHEMBL2181927 |
ChEBI ID | — |
PubChem CID | 60150535 |
DrugBank | DB16165 |
UNII ID | DE2O63YV8R (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 824 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7 adverse events reported
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