Sacubitril
Active ingredient
Sold as Neparvis · ENTRESTO
- Drug class
- -
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 24
- FDA reports (12 mo)
- 2,572
Overview
Sacubitril is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 9 | April 2, 2026 |
| GB United Kingdom | MHRA | 7 | May 8, 2026 |
| US United States | FDA | 6 | April 1, 2026 |
| EU European Union | EMA | 2 | January 13, 2026 |
CACanada· Health Canada
9 products
Uses
38 Sandoz Sacubitril-Valsartan (sacubitril/valsartan) Product Monograph Page 3 of 43 PrSANDOZ SACUBITRIL-VALSARTAN sacubitril / valsartan film-coated tablets PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Oral Film coated tablets: 24 mg sacubitril / 26 mg valsartan 49 mg sacubitril / 51 mg valsartan 97 mg sacubitril / 103 mg valsartan Colloidal silicon dioxide, crospovidone, low- substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose and talc.
The film- coating contains hypromellose, iron oxide red (E 172), Macrogol 4000, talc and titanium dioxide (E 171). Sandoz Sacubitril-Valsartan 24 mg sacubitril / 26 mg valsartan and Sandoz Sacubitril-Valsartan 97 mg sacubitril / 103 mg valsartan film-coated tablets also contain iron oxide black (E 172), and Sandoz Sacubitril- Valsartan 49 mg sacubitril / 51 mg valsartan film-coated tablets also contain iron oxide yellow (E 172).
GBUnited Kingdom· MHRA
7 products
Uses
1).
How to take
USUnited States· FDA
6 products
Uses
1 INDICATIONS AND USAGE 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. 1 ) 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 Adult Heart Failure ENTRESTO 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. 1)] . 2 Pediatric Heart Failure ENTRESTO is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
EUEuropean Union· EMA
2 products
Uses
1). 1).
How to take
Drug interactions
Known interactions involving Sacubitril. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 02549018 · revised October 16, 2025
- [2]MHRA (UK) · PL045691900 · revised May 8, 2026
- [3]FDA DailyMed · 000dc81d-ab91-45… · revised October 29, 2025 [PDF]
- [4]European Medicines Agency · EMEA/H/C/004062 · revised January 13, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.