ENTRESTO
Entresto is a combination medication indicated to reduce the risk of cardiovascular death and hospitalization in adults with chronic heart failure. The drug is also approved for the treatment of symptomatic heart failure in pediatric patients aged one year and older who have systemic left ventricular systolic dysfunction. In adult populations, therapeutic benefits are most clearly evident in patients with a left ventricular ejection fraction below normal. The treatment is expected to improve cardiovascular outcomes and has been shown to reduce NT-proBNP levels.
How ENTRESTO Works
Entresto functions through the dual action of a neprilysin inhibitor, sacubitril, and an angiotensin II receptor blocker, valsartan. Sacubitril’s active metabolite inhibits the enzyme neprilysin, which increases levels of beneficial peptides, such as natriuretic peptides, that are normally degraded by that enzyme. Simultaneously, valsartan selectively blocks the angiotensin II type-1 receptor, which inhibits the vasoconstrictive effects of angiotensin II and the release of aldosterone. These combined mechanisms result in cardiovascular and renal effects that assist in the management of heart failure.
Details
- Status
- Prescription
- First Approved
- 2015-07-07
- Routes
- ORAL
- Dosage Forms
- TABLET
ENTRESTO Approval History
What ENTRESTO Treats
2 indicationsENTRESTO is approved for 2 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic heart failure in adults
- Symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older
ENTRESTO Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue ENTRESTO as soon as possible (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue ENTRESTO as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue ENTRESTO as soon as possible (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue ENTRESTO as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ENTRESTO FDA Label Details
ProIndications & Usage
FDA Label (PDF)ENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. 1.1 Adu...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue ENTRESTO as soon as possible (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. Whe...
ENTRESTO Patents & Exclusivity
Patents (72 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.