Latest signals
What changed
The three most recent source-backed changes linked to this drug.
CardiovascularDrug intelligence
Entresto
Sacubitril/Valsartan
Neprilysin inhibitor with an angiotensin II receptor blocker. Developed by Novartis. Clinical, regulatory, and source evidence are connected below.
- Company
- Novartis
- Target / MOA
- Neprilysin · AT1 receptor
- Aliases
- Entresto · Entresto Sprinkle · Neparvis · LCZ696
- Signals
- 22
- Clinical trials
- 9
- Approvals
- 2
- Evidence sources
- 22
Approved uses
What regulators have approved
The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.
United States (FDA label)
Label section 1
1 INDICATIONS AND USAGE 1.1 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. LVEF is a variable measure, so use clinical judgment in deciding whom to treat [see Clinical Studies (14.1)] . 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. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes.
European Union (EMA)
Paediatric heart failure Entresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction. Adult heart failure Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.
Paediatric heart failure Neparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5.1). Adult heart failure Neparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).
EMA's summary; the full indication is in the product information on the EPAR page.
Regulatory history
Approvals over time
US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.
United States
3 efficacy supplements approved
- Apr 12, 2024 · supplement 25
- Feb 16, 2021 · supplement 18
- Oct 1, 2019 · supplement 13
European Union
- Entresto: Authorised since Nov 19, 2015
- Neparvis: Authorised since May 26, 2016
Patents and exclusivity
What FDA lists (US)
Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.
NDA207620 (Orange Book)
8 listed patents, latest expiry May 9, 2036
- US 9388134 · expires Nov 8, 2026 · U-1723
- US 9388134*PED · expires May 8, 2027 · no claim type flagged
- US 8877938 · expires May 27, 2027 · drug substance, drug product
- US 8877938*PED · expires Nov 27, 2027 · no claim type flagged
- US 11135192 · expires Aug 22, 2033 · U-3084
- US 9517226 · expires Aug 22, 2033 · U-3084
- US 9937143 · expires Aug 22, 2033 · U-3084
- US 11058667 · expires May 9, 2036 · U-3170
NDA218591 (Orange Book)
3 listed patents, latest expiry Feb 2, 2037
- US 9388134 · expires Nov 8, 2026 · U-1723
- US 8877938 · expires May 27, 2027 · drug substance, drug product
- US 10722471 · expires Feb 2, 2037 · drug product, U-3896
Generics and biosimilars
16 approved generics (ANDA)
- ALEMBIC PHARMACEUTICALS LTD · ANDA213682 · approved May 28, 2024
- CRYSTAL PHARMACEUTICAL SUZHOU CO LTD · ANDA213605 · approved May 28, 2024
- LAURUS LABS LTD · ANDA213676 · approved May 28, 2024
- ZYDUS PHARMACEUTICALS USA INC · ANDA213719 · approved Jul 9, 2024
- TORRENT PHARMACEUTICALS LTD · ANDA213604 · approved Aug 22, 2024
- BIOCON PHARMA LTD · ANDA213680 · approved Aug 30, 2024
- ALKEM LABORATORIES LTD · ANDA213764 · approved Sep 16, 2024
- MACLEODS PHARMACEUTICALS LTD · ANDA213728 · approved Oct 16, 2024
- LUPIN INC · ANDA213808 · approved Jan 8, 2025
- DR REDDYS LABORATORIES LTD · ANDA213627 · approved Jan 13, 2025
- MSN LABORATORIES PRIVATE LTD · ANDA213748 · approved Jul 16, 2025
- NOVUGEN PHARMA SDN BHD · ANDA213611 · approved Jul 16, 2025
- HETERO LABS LTD UNIT III · ANDA213668 · approved Jul 17, 2025
- SOMERSET THERAPEUTICS LLC · ANDA219983 · approved Jan 20, 2026
- UMEDICA LABORATORIES PRIVATE LTD · ANDA219946 · approved Aug 4, 2026
- AUROBINDO PHARMA LTD · ANDA213631 · approved Sep 2, 2026
*PED is FDA's mark for a patent's period extended by six months of pediatric exclusivity.
FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.
Safety
Boxed warnings and FDA safety communications
The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.
Boxed warning
Entresto, Entresto Sprinkle label
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)
FDA Drug Safety Communications
None on FDA's list names this drug.
Clinical trials
Key active studies
A focused view of recently updated studies · 9 linked records.
Effect of Sacubitril-Valsartan on Cardiac Structure and Function
Mayo Clinic · Updated Oct 9, 2026
Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients
University of Health Sciences Lahore · Updated Oct 2, 2026
Glucagon-like Peptide-1 Metabolism and Acute Neprilysin Inhibition
University of Pennsylvania · Updated Sep 21, 2026
Effect of Sacubitril-Valsartan on Estimated Pulmonary Artery Systolic Pressure in Patients With Heart Failure With Reduced Ejection Fraction Heart Failure
Aswan University · Updated Sep 11, 2026
Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension
Novartis Pharmaceuticals · Updated Aug 14, 2026
Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure
National Heart Institute, Egypt · Updated Aug 13, 2026
Regulatory timeline
Approvals and agency activity
Verified regulatory records in reverse chronological order.
Related intelligence
Connected drugs
Records connected through the current intelligence graph.
Source evidence
Where this profile comes from
Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.