NDAORALTABLETPriority Review
Approved
Jul 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
7/8 — Comprehensive
Priority Review
ENTRESTO (sacubitril and valsartan) by Novartis is angiotensin 2 receptor antagonists [moa]. Approved for angiotensin 2 receptor blocker [epc]. First approved in 2015.
Drug data last refreshed 14h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENTRESTO is an oral combination tablet of sacubitril (an ARNi) and valsartan (an ARB) approved in 2015 for heart failure. It works by blocking angiotensin II receptors and inhibiting neprilysin, reducing vasoconstriction and neurohormonal stress. The dual mechanism addresses both pressure overload and compensatory neurohormonal activation in heart failure patients.
$3.4BPart D
PeakStable
9.5 years to LOEPeak commercial stage with $3.4B annual spending and 722 linked jobs indicates a mature, well-resourced product team with established infrastructure.
Mechanism of Action
Angiotensin 2 Receptor Antagonists
Pharmacologic Class:
Angiotensin 2 Receptor Blocker
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure)
Started Dec 2024
30 enrolled
Pediatric Chronic Heart Failure
Sacubitril 97 mg and Valsartan 103 mg Film-coated Tablets Relative to Entresto 97 mg/103 mg Film-coated Tablets
Started May 2024
40 enrolled
Healthy Subjects
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Started Sep 2023
1,125 enrolled
Hypertension
Real World, Pharmacy-assessed Adherence to New Onset Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure
Started May 2023
0Heart Failure
Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension
Started Jan 2023
1,405 enrolled
Essential Hypertension
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.