SACUBITRIL AND VALSARTAN (sacubitril)
This combination therapy helps adults and children manage chronic heart failure by lowering the risk of cardiovascular death and hospital visits. It is particularly effective for adult patients whose hearts show a below-normal ejection fraction, though clinicians use their judgment based on the patient's specific needs. For children aged one year and older, the medication treats symptomatic heart failure and helps improve cardiovascular outcomes by reducing specific biomarkers like NT-proBNP.
How SACUBITRIL AND VALSARTAN Works
This drug works by simultaneously blocking the angiotensin II type-1 receptor and inhibiting the enzyme neprilysin. By stopping neprilysin from breaking down natriuretic peptides and blocking the effects of angiotensin II, the medication helps improve heart and kidney function. This dual approach also prevents the release of aldosterone, further supporting the cardiovascular system.
Details
- Status
- Prescription
- First Approved
- 2024-05-28
- Routes
- ORAL
- Dosage Forms
- TABLET
SACUBITRIL AND VALSARTAN Approval History
What SACUBITRIL AND VALSARTAN Treats
2 indicationsSACUBITRIL AND VALSARTAN is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Heart Failure
- Left Ventricular Systolic Dysfunction
SACUBITRIL AND VALSARTAN Boxed Warning
FETAL TOXICITY • When pregnancy is detected, discontinue Sacubitril and Valsartan Tablets 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 sacubitril and valsartan tablets as soon as possible. (5.1) • Drugs that act directly on the renin-angiotensin system can cause injury and ...
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue Sacubitril and Valsartan Tablets 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 sacubitril and valsartan tablets 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)
SACUBITRIL AND VALSARTAN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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.
SACUBITRIL AND VALSARTAN FDA Label Details
Indications & Usage
SACUBITRIL AND VALSARTAN is indicated for the treatment of Heart Failure; Left Ventricular Systolic Dysfunction.
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue Sacubitril and Valsartan Tablets 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 f...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.