Entresto(sacubitril)
Entresto, Neparvis (sacubitril) is a small molecule pharmaceutical. Sacubitril was first approved as Entresto on 2015-07-07. It has been approved in Europe to treat heart failure.
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Novartis Pharmaceuticals
Searched
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
Trade Name
FDA
EMA
Combinations
Entresto
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sacubitril
+
Valsartan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ENTRESTO | Novartis | N-207620 RX | 2015-07-07 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| entresto | New Drug Application | 2021-02-16 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SACUBITRIL / VALSARTAN, ENTRESTO, NOVARTIS PHARMS CORP | |||
| 2024-02-16 | M-82 | ||
| 2023-04-01 | PED | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Sacubitril / Valsartan, Entresto, Novartis Pharms Corp | |||
| 11058667 | 2036-05-09 | U-3170 | |
| 9517226 | 2033-08-22 | U-3084 | |
| 9937143 | 2033-08-22 | U-3084 | |
| 11135192 | 2033-08-22 | U-3084 | |
| 8877938 | 2027-05-27 | DS, DP | |
| 9388134 | 2026-11-08 | U-1723 | |
| 8101659 | 2025-01-15 | DP | |
| 7468390 | 2023-11-27 | DP | |
| 8404744 | 2023-01-14 | DP | |
| 8796331 | 2023-01-14 | U-1723 | |
HCPCS
No data
Clinical
Clinical Trials
145 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 2 | 11 | 15 | 30 | 23 | 78 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 10 | 7 | 5 | 2 | 23 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | 1 | 2 | 3 | 6 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | 1 | 2 | — | 4 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 2 | 1 | 1 | 1 | 4 |
| Left ventricular dysfunction | D018487 | — | 1 | — | 1 | 1 | 3 | ||
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | 1 | — | 3 |
| Blood pressure | D001794 | EFO_0004325 | — | 1 | — | 1 | — | 2 | |
| Cardiotoxicity | D066126 | EFO_1001482 | — | — | — | 1 | 1 | 2 | |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | — | 1 | 1 | 2 |
Show 13 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Essential hypertension | D000075222 | I10 | — | 2 | 4 | — | — | 6 | |
| Hypertrophic cardiomyopathy | D002312 | EFO_0000538 | I42.1 | — | 3 | 1 | — | — | 3 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 2 | 1 | — | — | 2 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | 1 | — | 1 | 2 | |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | — | 1 | — | — | 1 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | 1 | — | — | 1 |
| Chagas cardiomyopathy | D002598 | EFO_0005529 | — | — | 1 | — | — | 1 | |
| St elevation myocardial infarction | D000072657 | — | — | 1 | — | — | 1 | ||
| Renin-angiotensin system | D012084 | — | 1 | 1 | — | — | 1 | ||
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial remodeling | D064752 | — | 1 | — | — | 1 | 2 | ||
| Ventricular remodeling | D020257 | — | 1 | — | — | 1 | 2 | ||
| Myositis | D009220 | EFO_0000783 | G72.49 | — | 1 | — | — | — | 1 |
| Fibrosis | D005355 | — | 1 | — | — | — | 1 | ||
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | 1 | — | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | 1 | — | — | — | 1 |
| Metabolism | D008660 | GO_0008152 | — | 1 | — | — | — | 1 | |
| Energy metabolism | D004734 | — | 1 | — | — | — | 1 | ||
| Male breast neoplasms | D018567 | — | 1 | — | — | — | 1 |
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Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Frailty | D000073496 | R53.1 | — | — | — | — | 1 | 1 | |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | 1 | 1 | ||
| Cardio-renal syndrome | D059347 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SACUBITRIL |
| INN | sacubitril |
| Description | Sacubitril is a member of biphenyls. |
| Classification | Small molecule |
| Drug class | endopeptidase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCOC(=O)[C@H](C)C[C@@H](Cc1ccc(-c2ccccc2)cc1)NC(=O)CCC(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 149709-62-6 |
| RxCUI | 1656328 |
| ChEMBL ID | CHEMBL3137301 |
| ChEBI ID | — |
| PubChem CID | 9811834 |
| DrugBank | DB09292 |
| UNII ID | 17ERJ0MKGI (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Entresto - Novartis
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,276 documents
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Safety
Black-box Warning
Black-box warning for: Entresto
Adverse Events
Top Adverse Reactions
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686 adverse events reported
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