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Drug ReportsSacubitril
Entresto(sacubitril)
Entresto, Neparvis, Sacubitril / Valsartan (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
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FDA approval date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
Trade Name
FDA
EMA
Combinations
Entresto, Sacubitril valsartan
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 SPRINKLENovartisN-218591 RX2024-04-12
2 products, RLD, RS
ENTRESTONovartisN-207620 RX2015-07-07
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
entrestoNew Drug Application2024-07-22
sacubitril and valsartanANDA2024-12-10
Agency Specific
FDA
EMA
Expiration
Code
SACUBITRIL / VALSARTAN, ENTRESTO, NOVARTIS PHARMS CORP
2024-02-16M-82
Patent Expiration
Patent
Expires
Flag
FDA Information
Sacubitril / Valsartan, Entresto, Novartis Pharms Corp
110586672036-05-09U-3170
95172262033-08-22U-3084
99371432033-08-22U-3084
111351922033-08-22U-3084
88779382027-05-27DS, DP
93881342026-11-08U-1723
81016592025-01-15DP
ATC Codes
C: Cardiovascular system drugs
— C09: Agents acting on the renin-angiotensin system
— C09D: Angiotensin ii receptor blockers (arbs), combinations
— C09DX: Angiotensin ii receptor blockers (arbs), other combinations
— C09DX04: Valsartan and sacubitril
HCPCS
No data
Clinical
Clinical Trials
199 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 failureD006333HP_0001635I50418194343123
HypertensionD006973EFO_0000537I10—14146538
Essential hypertensionD000075222—I10—561113
Systolic heart failureD054143EFO_1001207I50.20——1449
Myocardial infarctionD009203EFO_0000612I21—14319
InfarctionD007238EFO_0009463——14218
ObesityD009765EFO_0001073E66.9—31126
Left ventricular dysfunctionD018487———12115
HypertrophyD006984EFO_0002460——411—5
Systolic murmursD054160—R01.1—12115
Show 36 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ventricular remodelingD020257———22—37
CardiomyopathiesD009202EFO_0000318I42—33——5
Hypertrophic cardiomyopathyD002312EFO_0000538I42.1—31——3
Heart diseasesD006331EFO_0003777I51.9—21—13
Renal insufficiencyD051437HP_0000083N19111——3
Inferior wall myocardial infarctionD056989EFO_1000983———1—12
St elevation myocardial infarctionD000072657————2——2
Congenital heart defectsD006330HP_0001627Q24.9—11—12
Pulmonary hypertensionD006976EFO_0001361I27.20——1——1
Erectile dysfunctionD007172EFO_0004234F52.21——1——1
Show 7 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———21———3
Atrial remodelingD064752———1——12
Covid-19D000086382——11——12
Hiv infectionsD015658EFO_0000764B20—2———2
Diastolic heart failureD054144EFO_1000899I50.30—2———2
HypersensitivityD006967HP_0012393T78.40—2———2
Chronic renal insufficiencyD051436—N1821———2
MyositisD009220EFO_0000783G72.49—1———1
Metabolic diseasesD008659EFO_0000589E88.9—1———1
Insulin resistanceD007333HP_0000855——1———1
Show 13 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Thyroid neoplasmsD013964EFO_0003841—1————1
Papillary thyroid cancerD000077273——1————1
Thyroid diseasesD013959HP_0000820E00-E071————1
Therapeutic equivalencyD013810——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FrailtyD000073496—R53.1————11
Hematopoietic stem cell transplantationD018380——————11
HyperkalemiaD006947HP_0002153E87.5————11
Cardio-renal syndromeD059347——————11
LymphomaD008223—C85.9————11
Univentricular heartD000080039—Q20.4————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSacubitril
INNsacubitril
Description
Sacubitril is a member of biphenyls.
Classification
Small molecule
Drug classendopeptidase inhibitors
Image (chem structure or protein)Loading
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-ID149709-62-6
RxCUI—
ChEMBL IDCHEMBL3137301
ChEBI ID—
PubChem CID9811834
DrugBankDB09292
UNII ID17ERJ0MKGI (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Entresto – Novartis
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Estimated US medical usage
Sacubitril
+
Valsartan
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,426 documents
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Safety
Black-box Warning
Black-box warning for: Entresto, Sacubitril and valsartan
Adverse Events
Top Adverse Reactions
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109,861 adverse events reported
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